Trial Information

TREATMENT OF ALL IN FIRST BONE MARROW RELAPSE AFTER BFM PROTOCOLS

OBJECTIVES: I. Evaluate the feasibility, at GATLA, of a study of the treatment of ALL in
first hematologic relapse following treatment on a BFM protocol. II. Evaluate the efficacy
of induction with vincristine/daunorubicin/asparaginase/prednisone in producing a second
complete remission in these patients, and evaluate the toxicity of this regimen. III.
Evaluate the efficacy and toxicity of the Capizzi I regimen
(vincristine/asparaginase/methotrexate) and Capizzi II regimen
(cytarabine/asparaginase/daunorubicin) when given to maintain and prolong complete
remission. IV. Offer the option of bone marrow transplantation to those patients who are in
second remission and who have a histocompatible donor, and compare outcome of these patients
with those on chemotherapy alone.

OUTLINE: Nonrandomized study. Patients achieving remission on Induction proceed to Interim
Maintenance, then to Continued Maintenance; those failing to achieve remission receive
Salvage Re-induction, followed, if remission is achieved, by Interim Maintenance, then
Continued Maintenance. Induction: 4-Drug Combination Chemotherapy with CNS
Prophylaxis/Therapy. Vincristine, VCR, NSC-67574; Prednisone, PRED, NSC-10023; Asparaginase,
ASP, NSC-109229; Daunorubicin, DNR, NSC-82151; with Intrathecal Cytarabine, IT ARA-C,
NSC-63878; Intrathecal Dexamethasone, IT DM, NSC-34521. Interim Maintenance: 3-Drug
Combination Chemotherapy with, as indicated, Radiotherapy. VCR; ASP; Methotrexate, MTX,
NSC-740; with, as indicated, testicular irradiation (equipment not specified). Continued
Maintenance: 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy
with CNS Prophylaxis and, as indicated, Radiotherapy. Capizzi II: ARA-C; ASP; DNR; followed
by Capizzi I: VCR; ASP; MTX; with IT ARA-C; IT DM; and, as indicated, cranial irradiation
(equipment not specified). Salvage Re-induction: 2-Drug Combination Chemotherapy. ARA-C;
ASP.

PROJECTED ACCRUAL: At least 72 evaluable patients will be entered. Accrual is expected to be
completed in 3 years.