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NCT00059839 · CITED IN SOURCE DOCUMENTS

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell 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
2014-09-22

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.

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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

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival (EFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Newly diagnosed advanced anaplastic large cell lymphoma * Cluster of differentiation antigen 30 (CD30+) * Murphy stage III or IV * No B-cell large cell lymphoma * No disease limited to the skin (regardless of how wide-spread) PATIENT CHARACTERISTICS: Age * Under 21 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma) Renal * Not specified Cardiovascular * Shortening fraction (SF) at least 27% by echocardiogram OR * Ejection fraction (EF) at least 50% by radionuclide angiogram Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Prior steroids for management of a mediastinal mass allowed Radiotherapy * Prior limited-dose radiotherapy for a mediastinal mass allowed Surgery * Not specified
healthy Volunteers
false
maximum Age
20 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: doxorubicin hydrochloride
    2. Drug: mercaptopurine
    3. Drug: methotrexate
    4. Drug: prednisone
    5. Drug: vincristine sulfate
    label
    Standard APO with Vincristine (Arm I )
    type
    EXPERIMENTAL
  2. description
    In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: doxorubicin hydrochloride
    2. Drug: mercaptopurine
    3. Drug: methotrexate
    4. Drug: prednisone
    5. Drug: vinblastine sulfate
    label
    Consolidation with Vinblastine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Consolidation with Vinblastine
    2. Standard APO with Vincristine (Arm I )
    description
    Given IV
    name
    doxorubicin hydrochloride
    type
    DRUG
  2. arm Group Labels
    1. Consolidation with Vinblastine
    2. Standard APO with Vincristine (Arm I )
    description
    Given by mouth
    name
    mercaptopurine
    type
    DRUG
  3. arm Group Labels
    1. Consolidation with Vinblastine
    2. Standard APO with Vincristine (Arm I )
    description
    Given IV and intrathecally
    name
    methotrexate
    type
    DRUG
  4. arm Group Labels
    1. Consolidation with Vinblastine
    2. Standard APO with Vincristine (Arm I )
    description
    Given by mouth
    name
    prednisone
    type
    DRUG
  5. arm Group Labels
    1. Consolidation with Vinblastine
    description
    Given IV
    name
    vinblastine sulfate
    type
    DRUG
  6. arm Group Labels
    1. Standard APO with Vincristine (Arm I )
    description
    Given IV
    name
    vincristine sulfate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
129
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.
    measure
    Event-free Survival (EFS)
    time Frame
    From first enrollment up to 3 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. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
detailed Description
OBJECTIVES: * Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine, in terms of event-free survival, in patients with advanced anaplastic large cell lymphoma. * Compare overall survival of patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Correlate biological tumor characteristics and outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine (VBL). * Induction therapy: All Patients receive doxorubicin IV over 15 minutes on days 1 and 22; vincristine IV on days 1, 8, 15, 22, and 29; oral prednisone 3 times daily on days 1-28; and intrathecal (IT) methotrexate on days 1, 8, and 22 (patients with central nervous system (CNS) disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36). Patients undergo restaging after Induction such that consolidation therapy is started on day 43. All patients with complete response (CR), complete response unconfirmed (CRu) or partial response (PR) proceed to Consolidation based on CT or MRI scans at the end of induction (week 6). All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study. Follow-up data will be required unless consent is withdrawn. * Standard APO (Arm I): Patients receive course-specific regimens without vinblastine. * Courses 1-3: Patients receive doxorubicin IV over 15 minutes, vincristine IV, and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5. * Courses 4-5: Patients receive doxorubicin, vincristine, prednisone, and mercaptopurine as in courses 1-3. * Courses 6-15: Patients receive vincristine, prednisone, and mercaptopurine as in courses 1-3 and methotrexate IV on day 1. * Consolidation with vinblastine (Arm II): Patients receive course-specific regimens including vinblastine. * Courses 1-3: Patients receive doxorubicin, methotrexate IT, prednisone, and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15. * Courses 4-5: Patients receive doxorubicin, prednisone, and mercaptopurine as in arm I and vinblastine as in arm II (courses 1-3). * Courses 6-15: Patients receive prednisone and mercaptopurine as in arm I, vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1. In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.
Source references
references
  1. citation
    Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. doi: 10.1002/pbc.25187. Epub 2014 Aug 23.
    pmid
    25156886
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        cit/section_3.66">66</a>] The prognostic implication of the small cell variant of anaplastic large cell lymphoma was also shown in the <a href="/clinicaltrials/NCT00059839">COG-ANHL0131</a> (NCT00059839) study, despite using a different chemotherapy backbone.[<a href="#cit/section_3.67">67</a>]</p> </section> <p id="_
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        rognostic implication of the small cell variant of anaplastic large cell lymphoma was also shown in the <a href="/clinicaltrials/NCT00059839">COG-ANHL0131</a> (NCT00059839) study, despite using a different chemotherapy backbone.[<a href="#cit/section_3.67">67</a>]</p> </section> <p id="_1952" tabindex="-1">For informa
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        a>] This suggests that the longer therapy in the vinblastine group delayed, but did not prevent, relapse. </li></ul></div></li><li>The <a href="/clinicaltrials/NCT00059839">COG-ANHL0131 (NCT00059839)</a> trial showed that the addition of vinblastine to the doxorubicin, prednisone, and vincristine (APO) regimen increased toxicity,
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        longer therapy in the vinblastine group delayed, but did not prevent, relapse. </li></ul></div></li><li>The <a href="/clinicaltrials/NCT00059839">COG-ANHL0131 (NCT00059839)</a> trial showed that the addition of vinblastine to the doxorubicin, prednisone, and vincristine (APO) regimen increased toxicity, but did not improve the su
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    Preserved source evidence · Independent clinical review pending · Not medical advice