Search / Trial NCT00002574

Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Aug 9, 2004

Trial Information

Current as of December 26, 2024

Completed

Keywords

Relapsing Chronic Myelogenous Leukemia Chronic Phase Chronic Myelogenous Leukemia

ClinConnect Summary

OBJECTIVES:

I. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase.

OUTLINE:

Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Chronic myelogenous leukemia (CML) in chronic phase
  • Clonal evolution (i.e., the presence of clones other than the Ph chromosome) allowed Ph chromosome variants or complex Ph chromosome translocations are not considered disease acceleration
  • Ineligible for known therapy of higher efficacy or priority
  • Allogeneic bone marrow transplantation should be considered priority therapy for CML patients with a matched related donor
  • No blastic phase CML (30% or more blasts in peripheral blood or bone marrow)
  • No accelerated phase CML, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils
  • Thrombocytopenia (platelets less than 100,000) unrelated to therapy
  • Documented extramedullary disease outside of liver or spleen
  • PATIENT CHARACTERISTICS:
  • Age: 15 and over
  • Performance status: Zubrod 0-2
  • Life expectancy: Sufficient to fully evaluate the effects of 2 courses of therapy
  • Bilirubin no greater than 2.0 mg/dL
  • SGOT less than 300
  • Creatinine less than 2.0 mg/dL OR creatinine clearance at least 60 mL/min
  • No severe heart disease (class III/IV)
  • No pregnant or nursing women
  • Effective contraception required of fertile women
  • PRIOR CONCURRENT THERAPY:
  • No prior interferon alpha
  • At least 2 weeks since antileukemic therapy, with recovery required
  • Patients who received hydroxyurea within the past 2 weeks and have WBC greater than 50,000 may enter protocol after discussion with the primary investigator

Trial Officials

Susan M. O'Brien, MD

Study Chair

M.D. Anderson Cancer Center

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Houston, Texas, United States

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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