Skip to content
Triangle logo TriangleGet started
← Study library

NCT00004228 · CITED IN SOURCE DOCUMENTS

Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2019-08-06

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Event-free Survival

→

outcome · POSTED

Percentage of Patients With Overall Survival as Assessed by Time to Death

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma\* * Less than 25% tumor cells in the bone marrow * Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours) * Stage III or IV disease * NOTE: \*Localized lymphoblastic lymphoma is closed to accrual as of 10/2005 PATIENT CHARACTERISTICS: Age: * 1 to 30 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * Adequate cardiac function PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy Radiotherapy: * Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy Surgery: * Not specified Other: * No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
healthy Volunteers
false
maximum Age
30 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: mercaptopurine
    8. Drug: methotrexate
    9. Drug: prednisone
    10. Drug: thioguanine
    11. Drug: vincristine sulfate
    label
    A0 (localized disease Stg I/II) Modified CCG BFM
    type
    EXPERIMENTAL
  2. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: mercaptopurine
    8. Drug: methotrexate
    9. Drug: prednisone
    10. Drug: thioguanine
    11. Drug: vincristine sulfate
    label
    A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    type
    EXPERIMENTAL
  3. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: mercaptopurine
    8. Drug: methotrexate
    9. Drug: prednisone
    10. Drug: thioguanine
    11. Drug: vincristine sulfate
    label
    A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    type
    EXPERIMENTAL
  4. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: leucovorin calcium
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    type
    EXPERIMENTAL
  5. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: leucovorin calcium
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    type
    EXPERIMENTAL
  6. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: leucovorin calcium
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    type
    EXPERIMENTAL
  7. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: leucovorin calcium
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    asparaginase
    other Names
    1. E.coli L-asparaginase
    2. EC 3.5.2.2
    3. colaspase
    4. L-asnase
    5. Elspar
    6. Kidrolase
    7. Crasnitin
    8. Leunase
    9. NSC#109229
    type
    DRUG
  2. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. Cytoxan
    2. NSC #26271
    type
    DRUG
  3. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    cytarabine
    other Names
    1. cytosine arabinoside
    2. Ara-C
    3. Cytosar
    4. NSC #63878
    type
    DRUG
  4. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    daunorubicin hydrochloride
    other Names
    1. daunomycin
    2. rubidomycin
    3. Cerubidine
    4. NSC #82151
    type
    DRUG
  5. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    dexamethasone
    other Names
    1. Decadron
    2. Hexadrol
    3. Dexone
    4. Dexameth
    5. NSC #34521
    type
    DRUG
  6. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    doxorubicin hydrochloride
    other Names
    1. Adriamycin
    2. NSC #123127
    type
    DRUG
  7. arm Group Labels
    1. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    2. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    3. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    4. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    leucovorin calcium
    other Names
    1. LCV
    2. Wellcovorin
    3. citrovorum factor
    4. folinic acid
    5. NSC #003590
    type
    DRUG
  8. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    mercaptopurine
    other Names
    1. 6-MP
    2. Purinethol
    3. 6-mercaptopurine
    4. NSC #000755
    type
    DRUG
  9. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    methotrexate
    other Names
    1. MTX
    2. amethopterin
    3. Trexall
    4. NSC #000740
    type
    DRUG
  10. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    prednisone
    other Names
    1. Deltasone
    2. Meticorten
    3. Orasone
    4. Liquid Pred
    5. Pediapred
    6. Sterapred
    7. NSC #010023
    type
    DRUG
  11. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given PO
    name
    thioguanine
    other Names
    1. 6-thioguanine
    2. 2-amino-1,7-dihydro-6H-purine-6-thione
    3. WR-1141
    4. Tabloid
    5. Lanvis
    6. NSC # 751
    type
    DRUG
  12. arm Group Labels
    1. A0 (localized disease Stg I/II) Modified CCG BFM
    2. A1 (Disseminated, No CNS - CCG mod BFM w/out intens
    3. A2 (Disseminated, No CNS - CCG mod BFM w/ intens
    4. B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
    5. B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
    6. B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
    7. B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    description
    Given IV
    name
    vincristine sulfate
    other Names
    1. Oncovin
    2. VCR
    3. LCR
    4. NSC #67574
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
393
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
    measure
    Event-free Survival
    time Frame
    5 years
secondary Outcomes
  1. description
    Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
    measure
    Percentage of Patients With Overall Survival as Assessed by Time to Death
    time Frame
    5 years
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
detailed Description
OBJECTIVES: * Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens\*. * Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHL/BFM 90 in these patients. * Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients. * Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease. * Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens. * Determine the prevalence of bone marrow involvement at presentation in these patients. * Determine whether peripheral blood can replace bone marrow in the initial staging of these patients. * Determine the clinical significance of bone marrow and peripheral blood involvement in these patients. NOTE: \*All patients as of 4/2006 receive treatment on Arm III regimen only OUTLINE: Patients are stratified by disease characteristics (disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma \[localized lymphoblastic lymphoma is closed to accrual as of 10/2005\]) and age. Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms\*. Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy. Patients with localized lymphoblastic lymphoma (closed to accrual as of 10/2005) are not randomized. NOTE: \*All patients as of 4/2006 receive treatment on Arm III only * Localized lymphoblastic lymphoma (closed to accrual as of 10/2005): * Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; oral prednisone on days 0-27; and asparaginase intramuscularly (IM) on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate intrathecally (IT) on days 7 and 28 and cytarabine IT on day 0. * Consolidation (5 weeks): Patients receive methotrexate IT on days 0, 7, 14, and 21 followed by cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days. * Interim maintenance (8 weeks): Patients receive methotrexate IT on days 0 and 28; oral mercaptopurine on days 0-41; and oral methotrexate on days 7, 14, 21, and 35. * Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, and 14; asparaginase IM on day 3 and then 3 times a week for 6 doses; oral dexamethasone on days 0-30; cyclophosphamide IV over 1 hour on day 28; and cytarabine IV or SC on days 28-31 and 35-38. Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days 28 and 35. * Maintenance (84 day course): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; oral mercaptopurine on days 0-83; and methotrexate IT on day 0. * Disseminated lymphoblastic lymphoma: * Arm I (closed to accrual as of 4/2006): Patients receive same induction, consolidation, and interim maintenance therapy schedule as localized lymphoblastic lymphoma patients. * Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42. * Maintenance (84 day course): Patients receive same therapy as localized lymphoblastic lymphoma patients, except methotrexate IT is administered on day 0 and 28 (for first 4 courses). * Arm II (closed to accrual as of 4/2006): Patients receive consolidation, interim maintenance, and maintenance therapy as in arm I. * Induction (5 weeks): Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-27; and asparaginase IM on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate IT on days 7 and 28; cyclophosphamide IV over 1 hour on day 2; and cytarabine IT on day 0. * Delayed intensification (7 weeks): Patients receive vincristine IV on days 0, 7, 14, 21; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42. * Arm III: * Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 1 hour on days 0, 7, 14, and 21 and oral prednisone on days 0-37. Patients also receive asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7 and 28; and cytarabine IT on day 0. * Consolidation (5 weeks): Patients receive methotrexate IT and cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV or SC on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days. * Interim maintenance (9 weeks): Patients receive methotrexate IT and IV on days 7, 21, 35, and 49; oral mercaptopurine on days 0-55; and leucovorin calcium IV at 42, 48, and 54 hours after methotrexate IV. * Delayed intensification (10 weeks): Patients receive vincristine IV and doxorubicin IV over 1 hour on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42. * Maintenance (84 day courses): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and oral mercaptopurine on days 0-83. * Arm IV (closed to accrual as of 4/2006): Patients receive consolidation and interim maintenance therapy as in arm III. * Induction: Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-37; asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7, 14, 21, and 28; cyclophosphamide IV on day 2; and cytarabine IT on day 0. * Delayed intensification (10 weeks): Patients receive vincristine IV on days 7, 14, 21, and 28; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42. * Maintenance (84 day courses): Patients receive therapy as in arm III. Patients who are over 1 year of age and have CNS disease at diagnosis undergo cranial radiotherapy once daily 5 days a week beginning on day 0. Patients over 2 years of age undergo radiotherapy over 11-14 days (6-9 days for 1-2 years of age). Patients are followed monthly for one year, every 3 months for 1 year, every 6 months for 1.5 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 250-400 patients will be accrued for this study within 5 years.
Source references
references
  1. citation
    Patel JL, Smith LM, Anderson J, Abromowitch M, Campana D, Jacobsen J, Lones MA, Gross TG, Cairo MS, Perkins SL. The immunophenotype of T-lymphoblastic lymphoma in children and adolescents: a Children's Oncology Group report. Br J Haematol. 2012 Nov;159(4):454-61. doi: 10.1111/bjh.12042. Epub 2012 Sep 21.
    pmid
    22994934
    type
    RESULT
  2. citation
    Termuhlen AM, Smith LM, Perkins SL, Lones M, Finlay JL, Weinstein H, Gross TG, Abromowitch M. Outcome of newly diagnosed children and adolescents with localized lymphoblastic lymphoma treated on Children's Oncology Group trial A5971: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1229-33. doi: 10.1002/pbc.24149. Epub 2012 Apr 5.
    pmid
    22488718
    type
    RESULT
  3. citation
    Coustan-Smith E, Sandlund JT, Perkins SL, Chen H, Chang M, Abromowitch M, Campana D. Minimal disseminated disease in childhood T-cell lymphoblastic lymphoma: a report from the children's oncology group. J Clin Oncol. 2009 Jul 20;27(21):3533-9. doi: 10.1200/JCO.2008.21.1318. Epub 2009 Jun 22.
    pmid
    19546402
    type
    RESULT
  4. citation
    Abromowitch M, Termuhlen A, Chang M, et al.: High-dose methotrexate and early intensification of therapy do not improve 3 year EFS in children and adolescents with disseminated lymphoblastic lymphoma: results of the randomized arms of COG A5971. [Abstract] Blood 112 (11): A-3610, 2008.
    type
    RESULT
  5. citation
    Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL; Children's Oncology Group. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Oct;51(4):489-94. doi: 10.1002/pbc.21666.
    pmid
    18618503
    type
    RESULT
  6. citation
    Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-d861ccda54948b5fdec5
      requested nct id
      NCT00004228
      primary nct id
      NCT00004228
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      f1f1a2b5d12aecd8245482e171eae02ca47aedde6097c4c21b97855f62bb55e0
      payload sha256
      c554243ef718bbdede896a7db8c46403d6d039749aaa44ebac52d031ea70ff55
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-d861ccda54948b5fdec5
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00004228
      occurrences
      1. context exact
        .[<a href="#cit/section_1.31">31</a>]</li><li><strong>T-cell lymphoblastic lymphoma:</strong> A Children's Oncology Group (COG) study (<a href="/clinicaltrials/NCT00004228">A5971 [NCT00004228]</a>) demonstrated a 2-year EFS rate of 91% for patients who had an MDD level by flow cytometry lower than 1% (n = 73), compared with 68% i
        end
        39669
        exact text
        NCT00004228
        start
        39658
      2. context exact
        ion_1.31">31</a>]</li><li><strong>T-cell lymphoblastic lymphoma:</strong> A Children's Oncology Group (COG) study (<a href="/clinicaltrials/NCT00004228">A5971 [NCT00004228]</a>) demonstrated a 2-year EFS rate of 91% for patients who had an MDD level by flow cytometry lower than 1% (n = 73), compared with 68% if the MDD level exce
        end
        39689
        exact text
        NCT00004228
        start
        39678
      3. context exact
        otherapy (low-stage treatment regimens for lymphoblastic lymphoma):</p> <div class="pdq-content-list"><ol id="_2049"><li><strong><a href="/clinicaltrials/NCT00004228">COG-A5971 (NCT00004228)</a></strong><strong>:</strong> Stage I or stage II patients (arm A0; localized disease) received a modified Children's Cancer Group (C
        end
        306654
        exact text
        NCT00004228
        start
        306643
      4. context exact
        tment regimens for lymphoblastic lymphoma):</p> <div class="pdq-content-list"><ol id="_2049"><li><strong><a href="/clinicaltrials/NCT00004228">COG-A5971 (NCT00004228)</a></strong><strong>:</strong> Stage I or stage II patients (arm A0; localized disease) received a modified Children's Cancer Group (CCG) BFM regimen and a re
        end
        306678
        exact text
        NCT00004228
        start
        306667
      5. context exact
        <div class="pdq-content-list"><ul id="_2421"><li>The 5-year DFS rate was 88%, and the OS rate was 85%.</li></ul></div></li><li><strong><a href="/clinicaltrials/NCT00004228">COG-A5971 (NCT00004228)</a></strong><strong>:</strong> This trial evaluated two strategies for CNS prophylaxis, without the use of CNS irradiation, for patien
        end
        307716
        exact text
        NCT00004228
        start
        307705
      6. context exact
        list"><ul id="_2421"><li>The 5-year DFS rate was 88%, and the OS rate was 85%.</li></ul></div></li><li><strong><a href="/clinicaltrials/NCT00004228">COG-A5971 (NCT00004228)</a></strong><strong>:</strong> This trial evaluated two strategies for CNS prophylaxis, without the use of CNS irradiation, for patients with stage III and st
        end
        307740
        exact text
        NCT00004228
        start
        307729
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/fd36e5abb88f40b91c.html
      source file sha256
      f1f1a2b5d12aecd8245482e171eae02ca47aedde6097c4c21b97855f62bb55e0
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:02.430571+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      82ec317f50f4df507988e345c98b7f250d282967704c0ba2eddd7b442373575f
      source title
      Childhood Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 17, 2025
        datetime
        2025-04-17T12:00:00Z
        display
        April 17, 2025

    Preserved source evidence · Not medical advice