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PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
Schering-Plough
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00303290
  Purpose

The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied. In some patients, extra blood samples will be taken to measure the effect of treatment on leukemia cells.


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: Peg Interferon Alpha 2b (Peg Intron)
Drug: Ara-C (cytosine arabinoside)
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Cytarabine Cytarabine hydrochloride Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To maintain the proportion of patients achieving a major cytogenetic response in patients with Ph-positive early chronic phase CML using PEG-Intron subcutaneously weekly and Ara-C subcutaneously daily.

Estimated Enrollment: 76
Study Start Date: January 2000
Detailed Description:

The objective of the clinical trial is to maintain the proportion of patients achieving a major cytogenetic response in patients with Ph-positive early chronic phase CML using PEG-Intron subcutaneously weekly and Ara-C subcutaneously daily.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 12 years or older with a diagnosis of Ph-positive or bcr-positive CML in early chronic phase CML (diagnosis < 12 months).
  • Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance status of 2 or less on Zubrod scale.
  • Patients under age 55 years should have HLA A,B,C, and DR typing performed on themselves and their siblings. Patients under age 20 years and patients with late chronic phase, accelerated phase or blastic phase will be offered allogeneic bone marrow transplantation from a matched sibling as the first priority.

Exclusion Criteria:

  • Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or lactating females
  • Women of pregnancy potential must practice birth control methods because of the potential risk of fetal teratogenicity with these agents.
  • Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
  • Definition of CML Phases: a. Early chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c. Accelerated phase CML: presence of any of the following features: - Peripheral or marrow blasts 15% or more - Peripheral or marrow basophils 20% or more - Thrombocytopenia < 100 x 109L unrelated to therapy - Documented extramedullary blastic disease outside liver or spleen
  • Continuation of # 4 d. Clonal evolution defined as the presence of additional clones other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-A therapy. Hence these patients will be eligible if no other therapy. Hence these patients will be eligible if no other accelerated phase signs are present.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303290

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Schering-Plough
Investigators
Principal Investigator: Jorge E Cortes, MD The University of Texas N.D. Anderson Cancer Center
  More Information

M.D. Anderson's website  This link exits the ClinicalTrials.gov site

Study ID Numbers: DM99-127
Study First Received: March 15, 2006
Last Updated: July 20, 2007
ClinicalTrials.gov Identifier: NCT00303290  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Early Chronic Phase CML
Peg Interferon Alpha 2b
Peg Intron
Ara-C
Cytosine Arabinoside

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Chronic myelogenous leukemia
Hematologic Diseases
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Peginterferon alfa-2b
Bone Marrow Diseases
Interferon Alfa-2a
Interferon Alfa-2b
Cytarabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009