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

November 25, 2015 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  5. 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 (22,23). Hence these patients will be eligible if no other therapy (22,23). Hence these patients will be eligible if no other accelerated phase signs are present.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-Intron + ARA-C
Peg Interferon Alpha 2b (Peg Intron) 4.5 micrograms/kg once a week. ARA-C 10 mg under the skin daily.
Drug: Peg Interferon Alpha 2b (Peg Intron)
4.5 micrograms/kg once a week
Drug: Ara-C (cytosine arabinoside)
10 mg under the skin daily
Other Names:
  • Cytosar
  • Cytarabine
  • DepoCyt
  • Cytosine arabinosine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Cytogenetic Response Rate after One Year on Therapy
Time Frame: 1 year
Cytogenetic responses evaluated by routine cytogenetics.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Schering-Plough

Investigators

  • Principal Investigator: Jorge E Cortes, MD, The University of Texas N.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria

March 15, 2006

First Posted (ESTIMATE)

March 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM99-127
  • NCI-2010-00887 (REGISTRY: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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