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Phase III Randomized Trial of Low-Dose ARA-C vs cis-Retinoic Acid in Preleukemia, ANLL, and CML

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedover 18UCCRC-3723
ICC-82L4, NCI-V83-0135

Objectives

I.  Compare the antileukemic activities of cytosine arabinoside administered 
in daily low doses vs. cis-retinoic acid in patients with peripheral 
cytopenias resulting from myeloproliferative disorders.
II.  Examine the abilities of cytosine arabinoside and cis-retinoic acid to 
cause leukemic cells to differentiate.
III.  Assess toxicity associated with these regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Adults who fall into one of the 
following categories:  dysmyelopoietic syndrome (FAB criteria); patients with 
evolving secondary ANLL; elderly patients who are not candidates for intensive 
chemotherapy for ANLL; patients with refractory ANLL or CML after conventional 
therapy.

Expected Enrollment

Protocol closed June 1985.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy.  Cytosine arabinoside, ARA-C, NSC-63878.
Arm II:  Single-agent Chemotherapy.  cis-Retinoic acid.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Harvey Golomb, MD, Protocol chair
Ph: 773-702-9200; 888-824-0200

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.

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