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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Chemotherapy with ROAP (RBD/VCR/ARA-C/PRED) plus Immunotherapy with MER for Acute Myelogenous Leukemia in Patients Over Age 50

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Supportive care, Treatment Closed over 50 MDA-DT-7760

Objectives

I.  Determine whether the protected environment prophylactic antibiotic (PEPA) 
program and prophylactic white blood cell transfusions can reduce the 
frequency of severe infections and improve the remission rate in patients over 
age 50 with acute leukemia.
II.  Determine the efficacy of the chemotherapy regimen ROAP:  rubidazone 
(RBD), vincristine (VCR), cytosine arabinoside (ARA-C), and prednisone (PRED).
III.  Determine the effect of methanol extraction residue (MER) of BCG.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over 50 years old with acute 
myelogenous leukemia and an absolute infiltrate of at least 50% leukemic cells 
or evidence of progressive disease.  Patients must not have had extensive 
prior therapy and must have adequate cardiac status.

Expected Enrollment

Protocol closed 02/79.

Outline

Randomized study.  If wbc donors are available, administer wbc transfusions to 
all patients and randomize them to Arm III or IV.  If wbc donors are not 
available randomize patients to Arm I or II, then rerandomize these patients 
to Arm III or IV.
Arm I:  Protected environment prophylactic antibiotic (PEPA) program.
Arm II:  No Prophylactic Program.
Arm III:  Induction and Consolidation:  4-Drug Combination Chemotherapy.  
ROAP:  Rubidazone, RBD, NSC-164011; Vincristine, VCR, NSC-67574; Cytosine 
Arabinoside, ARA-C, NSC-63878; Prednisone, PRED, NSC-10023.
Maintenance:  Single-agent Chemotherapy.  Cyclocytidine, CYC, NSC-145668.
Arm IV:  Induction and Consolidation:  4-Drug Combination Chemotherapy plus 
Immunotherapy.  ROAP; plus MER-BCG, MER, NSC-143769.
Maintenance:  Single-agent Chemotherapy.  CYC.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair
Ph: 713-792-2570; 800-392-1611

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.