Skip to content
Triangle logo TriangleGet started
← Study library

NCT01230983 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia or Advanced Lymphoblastic Non-Hodgkin's 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
2013-06-06

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's 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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: T-cell acute lymphoblastic leukemia (ALL) Registration on current ALL classification study (POG-9400) required within 6 working days prior to entry DR-, T+ DR-, T- or DR+, T+ eligible if T-cell ALL confirmed at the Johns Hopkins Reference Laboratory Biopsy-proven diffuse lymphoblastic lymphoma Murphy stage III/IV disease Registered on ALL classification study (POG-9400) PATIENT CHARACTERISTICS: Age: Over 12 months to under 22 years for T-ALL Under 22 years for lymphoma PRIOR CONCURRENT THERAPY: No prior therapy other than steroids or emergency mediastinal irradiation in patients with severe respiratory distress from mediastinal disease Steroid treatment allowed provided that physical examination and complete blood count with differential were performed immediately prior to beginning steroids and results of both are known
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Closed 09/2000 Induction (Vincristine sulfate, Prednisone, doxorubicin hydrochloride, Methotrexate (MTX), mercaptopurine (6-MP), methotrexate/cytarabine), Consolidation (Vincristine sulfate), Prednisone, doxorubicin hydrochloride, mercaptopurine (6-MP), asparaginase, IT methotrexate /cytarabine radiation therapy (XRT)). Continuation (Vincristine sulfate, Prednisone, IT methotrexate/Ara-C,mercaptopurine (6-MP), IT methotrexate/cytarabine)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: doxorubicin hydrochloride
    4. Drug: mercaptopurine
    5. Drug: methotrexate
    6. Drug: prednisone
    7. Drug: therapeutic hydrocortisone
    8. Drug: vincristine sulfate
    9. Radiation: radiation therapy
    label
    Treatment 1: (No HD MTX / No Zinecard)
    type
    EXPERIMENTAL
  2. description
    Closed 09/2000 Induction (Vincristine sulfate, Prednisone, doxorubicin hydrochloride, Methotrexate (MTX), mercaptopurine (6-MP), methotrexate/cytarabine, dexrazoxane hydrochloride (Zinecard or DZR)), Consolidation (Vincristine sulfate), Prednisone, doxorubicin hydrochloride, mercaptopurine (6-MP), asparaginase, dexrazoxane hydrochloride (Zinecard or DZR), IT methotrexate /cytarabine, radiation therapy (XRT)). Continuation (Vincristine sulfate, Prednisone, IT methotrexate/Ara-C,mercaptopurine (6-MP), IT methotrexate/cytarabine)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: dexrazoxane hydrochloride
    4. Drug: doxorubicin hydrochloride
    5. Drug: mercaptopurine
    6. Drug: methotrexate
    7. Drug: prednisone
    8. Drug: therapeutic hydrocortisone
    9. Drug: vincristine sulfate
    10. Radiation: radiation therapy
    label
    Treatment 2: (No HD MTX / Zinecard)
    type
    ACTIVE_COMPARATOR
  3. description
    Closed 09/2001 Induction (Vincristine sulfate, Prednisone, doxorubicin hydrochloride, Methotrexate (MTX), mercaptopurine (6-MP), leucovorin calcium (LCV), HD methotrexate/cytarabine), Consolidation (Vincristine sulfate), Prednisone, doxorubicin hydrochloride, mercaptopurine (6-MP), asparaginase, leucovorin calcium (LCV), HD methotrexate /cytarabine radiation therapy (XRT)). Continuation (Vincristine sulfate, Prednisone, IT methotrexate/Ara-C,mercaptopurine (6-MP), HD methotrexate/cytarabine)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: doxorubicin hydrochloride
    4. Drug: leucovorin calcium
    5. Drug: mercaptopurine
    6. Drug: methotrexate
    7. Drug: prednisone
    8. Drug: therapeutic hydrocortisone
    9. Drug: vincristine sulfate
    10. Radiation: radiation therapy
    label
    Treatment 3: (HD MTX / No Zinecard)
    type
    ACTIVE_COMPARATOR
  4. description
    Closed 09/2001 Induction (Vincristine sulfate, Prednisone, doxorubicin hydrochloride, Methotrexate (MTX), mercaptopurine (6-MP), leucovorin calcium (LCV), HD methotrexate/cytarabine, dexrazoxane hydrochloride (Zinecard or DZR)), Consolidation (Vincristine sulfate), Prednisone, doxorubicin hydrochloride, mercaptopurine (6-MP), asparaginase, HD methotrexate /cytarabine, dexrazoxane hydrochloride (Zinecard or DZR), radiation therapy (XRT)). Continuation (Vincristine sulfate, Prednisone, IT methotrexate/Ara-C,mercaptopurine (6-MP), HD methotrexate/cytarabine)
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: dexrazoxane hydrochloride
    4. Drug: doxorubicin hydrochloride
    5. Drug: leucovorin calcium
    6. Drug: mercaptopurine
    7. Drug: methotrexate
    8. Drug: prednisone
    9. Drug: therapeutic hydrocortisone
    10. Drug: vincristine sulfate
    11. Radiation: radiation therapy
    label
    Treatment 4: (HD MTX / Zinecard)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    asparaginase
    other Names
    1. E. coli
    2. Elspar
    3. NSC #10922
    type
    DRUG
  2. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    cytarabine
    other Names
    1. Cytosine Arabinoside
    2. AraC
    3. Cytosar
    4. NSC #06387
    type
    DRUG
  3. arm Group Labels
    1. Treatment 2: (No HD MTX / Zinecard)
    2. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    dexrazoxane hydrochloride
    other Names
    1. DZR
    2. ADR-529
    3. ZINECARD
    4. ICRF-187
    5. NSC #169780
    type
    DRUG
  4. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    doxorubicin hydrochloride
    other Names
    1. Doxorubicin
    2. NSC #123127
    type
    DRUG
  5. arm Group Labels
    1. Treatment 3: (HD MTX / No Zinecard)
    2. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    leucovorin calcium
    other Names
    1. LCV
    2. Wellcovorin
    3. citrovorum factor
    4. folinic acid
    5. NSC #003590
    type
    DRUG
  6. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given orally
    name
    mercaptopurine
    other Names
    1. 6-MP
    2. Purinethol
    3. NSC #000755
    type
    DRUG
  7. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    methotrexate
    other Names
    1. MTX
    2. amethopterin
    3. NSC #000740
    type
    DRUG
  8. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given orally
    name
    prednisone
    other Names
    1. Deltasone
    2. Meticorten
    3. Liquid Pred
    4. NSC #010023
    type
    DRUG
  9. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IT
    name
    therapeutic hydrocortisone
    other Names
    1. hydrocortisone sodium succinate
    2. Solu-cortef
    3. NSC #010483
    type
    DRUG
  10. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Given IV
    name
    vincristine sulfate
    other Names
    1. VCR
    2. Oncovin
    3. NSC #067574
    type
    DRUG
  11. arm Group Labels
    1. Treatment 1: (No HD MTX / No Zinecard)
    2. Treatment 2: (No HD MTX / Zinecard)
    3. Treatment 3: (HD MTX / No Zinecard)
    4. Treatment 4: (HD MTX / Zinecard)
    description
    Radiation to cranium
    name
    radiation therapy
    other Names
    1. XRT
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
573
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Since all patients receive the same induction, the endpoint will be CCR , i.e. complete continuous remission (the time to failure for any cause among patients achieving a complete response)
    measure
    Complete Continuous Remission
    time Frame
    Time to failure for any cause among patients achieving a complete response
secondary Outcomes
  1. description
    Endpoint will be abnormalities in the 31 week and the year 3 echocardiograms (i.e. year 1 off therapy). Secondarily, we shall compare the CCR rates for the two treatment regimens, in a two sided fashion.
    measure
    Abnormalities in the 31 week and the year 3 echocardiograms
    time Frame
    1 year off therapy
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.
detailed Description
OBJECTIVES: I. Determine, in a randomized trial, the effectiveness of high-dose methotrexate when added to a multiagent chemotherapy backbone (the Dana Farber Cancer Institute regimen, protocol DFCI-87001) proven effective in T-cell acute lymphoblastic leukemia (T-ALL) and advanced lymphoblastic non-Hodgkin's lymphoma (NHL). II. Determine the role of dexrazoxane in preventing cardiotoxicity in children with T-ALL and advanced lymphoblastic NHL treated with an anthracycline-based regimen. III. Study the biology of T-cell lymphoid malignancies by accumulating data on the concurrent ALL classification study (POG-9400) and analyzing the data relative to outcome. IV. Evaluate the correlation of minimal residual disease (using the TAL 1 proto-oncogene) with event-free survival. V. Determine the role of p53 and p16 tumor suppressor genes in T-ALL. VI. Determine whether drug sensitivity profiles of blast cells to doxorubicin, methotrexate, and cytarabine correlate with initial response and subsequent relapse. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease category (acute lymphoblastic leukemia (ALL) with no CNS disease vs. ALL with CNS disease vs. non-Hodgkin's lymphoma (NHL) with no CNS disease vs. NHL with CNS disease), gender, race (Caucasian vs. African American vs. Hispanic). Patients are randomized to one of four treatment arms. ARM I: During induction therapy, patients receive vincristine IV once daily on days 1, 8, 15, and 22, oral prednisone three times a day on days 1-21, doxorubicin IV daily on days 1, 2, and 22, methotrexate IV once, at least 8 hours after doxorubicin on day 2, and oral mercaptopurine daily on days 22-35. Patients receive triple intrathecal therapy (TIT) consisting of methotrexate, cytarabine, and hydrocortisone on weeks 1, 3, 4, 5, and 6. Patients with CNS 2 or 3 disease receive TIT on week 2. During weeks 7-33, patients receive consolidation therapy consisting of vincristine IV once every 3 weeks, oral prednisone three times a day over 5 days, every 3 weeks, doxorubicin IV once every 3 weeks, oral mercaptopurine daily for 14 days, every 3 weeks, and asparaginase intramuscularly (IM) weekly on weeks 7-26. Patients receive TIT on week 10 and 22 (on week 16 for patients with CNS 2 or 3 disease). Patients receive radiotherapy beginning on week 22. During weeks 34-108, patients receive continuation therapy consisting of vincristine IV once every 3 weeks, oral prednisone three times a day over 5 days, every 3 weeks, methotrexate IV or IM weekly (omitted during TIT) and oral mercaptopurine daily for 14 days, every 3 weeks. Patients receive TIT on weeks 40, 58, 76, and 94. Arm II: Patients receive induction therapy as in Arm I with an addition of dexrazoxane IV given prior to doxorubicin on days 1, 2, and 22. Patients receive consolidation therapy as in Arm I with an addition of dexrazoxane IV given prior to doxorubicin once every 3 weeks. Patients receive continuation therapy as in Arm I. Arm III: Patients receive induction therapy as in Arm I in addition to high dose methotrexate IV on week 4 and leucovorin calcium IV or orally every 6 hours for 7 doses beginning 36 hours after high dose methotrexate. Patients receive consolidation therapy as in Arm I in addition to high dose methotrexate IV on weeks 7, 10, and 13 followed by leucovorin calcium as in induction therapy. Patients receive continuation therapy as in Arm I. Arm IV: Patients receive induction therapy and consolidation therapy as in Arms I, II, and III. Patients receive continuation therapy as in Arm I. Treatment continues for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 3 years, then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 494 patients will be accrued for this study.
Source references
references
  1. citation
    Cleaver AL, Beesley AH, Firth MJ, Sturges NC, O'Leary RA, Hunger SP, Baker DL, Kees UR. Gene-based outcome prediction in multiple cohorts of pediatric T-cell acute lymphoblastic leukemia: a Children's Oncology Group study. Mol Cancer. 2010 May 12;9:105. doi: 10.1186/1476-4598-9-105.
    pmid
    20459861
    type
    BACKGROUND
  2. citation
    Salzer WL, Devidas M, Carroll WL, Winick N, Pullen J, Hunger SP, Camitta BA. Long-term results of the pediatric oncology group studies for childhood acute lymphoblastic leukemia 1984-2001: a report from the children's oncology group. Leukemia. 2010 Feb;24(2):355-70. doi: 10.1038/leu.2009.261. Epub 2009 Dec 17.
    pmid
    20016527
    type
    BACKGROUND
  3. citation
    Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.
    type
    BACKGROUND
  4. citation
    Seibel NL, Asselin BL, Nachman JB, et al.: Treatment of high risk T-cell acute lymphoblastic leukemia (T-ALL): comparison of recent experience of the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG). [Abstract] Blood 104 (11): A-681, 2004.
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-df2597815e5c8564cb3b
      requested nct id
      NCT01230983
      primary nct id
      NCT01230983
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      8416f6a719c496873bd76f9837e64f45de187c289bc5ec0bf994c3e18f233983
      payload sha256
      85fe841923c5365e4b6725c987f1cce4a84dea5347ed744247d8817c5f966630
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-df2597815e5c8564cb3b
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT01230983
      occurrences
      1. context exact
        e 5 years posttreatment.</li><li>A greater long-term protective effect was noted in girls than in boys.</li></ul></div></li><li>On the <a href="/clinicaltrials/NCT01230983">POG-9404</a> trial, patients with T-ALL were randomly assigned to receive dexrazoxane or not before each dose of doxorubicin (cumulative dose 360 mg/m<span cl
        end
        579262
        exact text
        NCT01230983
        start
        579251
      2. context exact
        9"><li>Protocols of the former Pediatric Oncology Group (POG) treated children with T-ALL differently from children with B-ALL. On the <a href="/clinicaltrials/NCT01230983">POG-9404</a> protocol, patients with T-ALL were treated using a regimen based on the DFCI 87-001 protocol, which included multiple doses of L-asparaginase and
        end
        765551
        exact text
        NCT01230983
        start
        765540
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/346ccc02fe964bb078.html
      source file sha256
      8416f6a719c496873bd76f9837e64f45de187c289bc5ec0bf994c3e18f233983
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:53.377184+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      d68ab4be374e916e0de9c7632347ccef2167b36c83a023ce62cc9bb0575973b9
      source title
      Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice