Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

Basic Trial Information

Objectives

1. 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.
2. Compare overall survival of patients treated with these regimens.
3. Compare the toxic effects of these regimens in these patients.
4. Correlate biological tumor characteristics and outcome in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Newly diagnosed advanced anaplastic large cell lymphoma
  • CD30+ disease
  • Murphy stage III or IV
• No B-cell large cell lymphoma
• No disease limited to the skin (regardless of how wide-spread)

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

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)
• AST or ALT less than 2.5 times ULN (unless due to lymphoma)

Renal

• Not specified

Cardiovascular

• Shortening fraction at least 27% by echocardiogram

  OR

• Ejection fraction at least 50% by radionuclide angiogram

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.

Outcomes

Event-free survival
Toxicity

Overall survival
Disease response

Outline

This is a randomized, multicenter study.

• Induction therapy: 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 CNS disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36).

  Patients then begin consolidation therapy on day 43.

• Consolidation therapy: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive course-specific regimens.
    • 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.

  • Arm II: Patients receive course-specific regimens.
    • 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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Jacqueline Kraveka, DO, Protocol chair		Ph: 843-792-2957 Email: kravekjm@musc.edu

Registry Information
Official Title		A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation with a Regimen Including Vinblastine
Trial Start Date		2003-11-03
Trial Completion Date		2009-12-02
Registered in ClinicalTrials.gov		NCT00059839
Date Submitted to PDQ		2003-03-06
Information Last Verified		2010-11-12
NCI Grant/Contract Number		CA98543

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