Trial Information

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

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.

- 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.

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