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

Chronic Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303290
• Other study ID #: DM99-127
• Secondary ID: NCI-2010-00887
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2006
• Last updated: November 25, 2015
• Start date: January 2000
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Peg Interferon Alpha 2b (Peg Intron)
4.5 micrograms/kg once a week
• Ara-C (cytosine arabinoside)
10 mg under the skin daily

Locations

Country	Name	City	State
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Cytogenetic Response Rate after One Year on Therapy	Cytogenetic responses evaluated by routine cytogenetics.	1 year	No

External Links

•   University of Texas MD Anderson Cancer Center Website