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PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

NCT00303290•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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.

Detailed Description

If you agree to take part in this study, during treatment, you will have blood tests every 1 to 4 weeks. After 10 years, blood tests are recommended 2 times per year. Bone marrow samples will be taken every 3 months during the first year and then every 3 to 6 months. If you are on this study for 10 years or longer, the bone marrow collections will only be performed if the doctor thinks it is needed. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. During treatment, you will receive PEG-Intron once a week. You will also receive Ara-C injections under the skin. You will be taught to inject yourself, or a family member or friend can be taught how to give injections. Treatment will be given to you in the outpatient clinic at MD Anderson or in a clinic close to you. You will receive treatment as long as it is helping to control the disease. Treatment will go on for about 5 to 20 years. This is an investigational study. The FDA has approved PEG-Intron only for research studies. About 100 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients age 12 years or older with a diagnosis of Ph-positive or bcr-positive CML in early chronic phase CML (diagnosis \< 12 months).
•2. Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance status of 2 or less on Zubrod scale.
•3. 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

•1. Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or lactating females
•2. Women of pregnancy potential must practice birth control methods because of the potential risk of fetal teratogenecity with these agents.
•3. 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.
•4. 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

Locations (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 1, 2000

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

November 26, 2015

Enrollment

ACTUAL participants

Conditions

Chronic Myeloid Leukemia

Interventions

Peg Interferon Alpha 2b (Peg Intron)

DRUG

Ara-C (cytosine arabinoside)

DRUG

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High-risk Myelodysplastic SyndromeChronic Myelomonocytic Leukemia (CMML)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML

Inclusion Criteria

Exclusion Criteria

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies