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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Schering-Plough |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00303290 |
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 |
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) |
Estimated Enrollment: | 76 |
Study Start Date: | January 2000 |
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Jorge E Cortes, MD | The University of Texas N.D. Anderson Cancer Center |
Study ID Numbers: | DM99-127 |
Study First Received: | March 15, 2006 |
Last Updated: | July 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00303290 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Early Chronic Phase CML Peg Interferon Alpha 2b Peg Intron Ara-C Cytosine Arabinoside |
Antimetabolites Interferon-alpha Interferon Type I, Recombinant Immunologic Factors Hematologic Diseases Interferons Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Immunosuppressive Agents |
Angiogenesis Inhibitors Antiviral Agents Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peginterferon alfa-2b Chronic Myelogenous Leukemia Bone Marrow Diseases Interferon Alfa-2a Interferon Alfa-2b Cytarabine |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Chronic-Phase Leukemia Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Cytarabine Interferon-alpha |
Neoplasms by Histologic Type Hematologic Diseases Growth Substances Interferons Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peginterferon alfa-2b Interferon Alfa-2a Bone Marrow Diseases |