Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed under 60 EORTC-LAM-4

Objectives

I.  Determine the efficacy of combination chemotherapy with ADR/VCR/ARA-C in 
Phase II treatment of acute myelogenous leukemia.
II.  Determine the influence of reinforcement therapy with ADR/ARA-C on the 
duration of remission in a Phase III study.
III.  Determine the differences in extent of remissions obtained with 
immunotherapy alone, chemotherapy alone or with combination chemoimmunotherapy.
IV.  Investigate whether partial responders following three remission 
induction courses may be brought into complete remission by prolongation of 
the induction course.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients less than 60 years of age 
with acute myelogenous leukemia.  Patients may be in early stages of the 
disease and may have more than 30% blast cells in the bone marrow.

Expected Enrollment

Protocol closed.

Outline

Study randomized for Reinforcement and Maintenance.  Enter all patients to 
Induction.  Complete responders are randomized to Arms I and II.  Responders 
are then rerandomized to Maintenance Arms III, IV, and V.
Induction:  3-Drug Combination Chemotherapy.  Adriamycin, ADR, NSC-123127; 
Vincristine, VCR, NSC-67574; Cytosine arabinoside, ARA-C, NSC-63878.
Reinforcement:
Arm I:  2-Drug Combination Chemotherapy.  ADR; ARA-C.
Arm II:  Control.  No Reinforcement Therapy.
Maintenance:
Arm III:  Immunotherapy.  Pasteur BCG, BCG, NSC-B116328, plus irradiated 
leukemic cells.
Arm IV:  2-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, NSC-26271; 
CCNU, NSC-79037.
Arm V:  2-Drug Combination Chemotherapy plus Immunotherapy.  CTX; CCNU; plus 
BCG and irradiated leukemic cells.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maurice J. Staquet, MD, Protocol chair		Ph: 32-2-541-3501