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Pegasys in Patients With Chronic Myeloid Leukemia (CML)

Primary Purpose

Leukemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PEG-IFNá-2a

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Chronic Myeloid Leukemia, CML, Tyrosine Kinase Inhibitors, TKI, Complete cytogenetic remission, CCyR, Minimal residual disease, MRD, PEG-IFNa-2a, Pegasys, Peginterferon Alpha-2a, Philadelphia chromosome (Ph)-positive, BCR-ABL1-positive

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
Patients are receiving an FDA-approved TKI for the management of CML.
Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
Patients must be in complete cytogenetic remission.
Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: 1. The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. The patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
Patients must not have had a known continuous interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and serum glutamate pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) </= 2.5x ULN.
Men and women of childbearing potential should practice effective methods of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.

Exclusion Criteria:

Patients receiving any non-FDA approved TKI.
Patients who are pregnant or breast-feeding.
Patients with clinically significant heart disease (NYHA Class III or IV).

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-IFNá-2a

Arm Description

PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.

Outcomes

Primary Outcome Measures

Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)

Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).

Secondary Outcome Measures

Full Information

NCT ID

NCT01392170

First Posted

July 8, 2011

Last Updated

April 13, 2015

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01392170

Brief Title

Pegasys in Patients With Chronic Myeloid Leukemia (CML)

Official Title

Phase II Study of Pegylated Ifná-2a (Pegasys) in Patients With Chronic Myeloid Leukemia Who Have Minimal Residual Disease While Receiving Therapy With Tyrosine Kinase Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Slow Accrual

Study Start Date

October 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied. Pegasys is a form of the drug interferon. It is designed to help the body's immune system to fight infections. It may also affect the body's response to cancer. A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from growing, and may cause them to die. You are already receiving a TKI. This consent form will describe the administration of Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys, and any risks/benefits there may be from receiving Pegasys.

Detailed Description

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive Pegasys through a needle under the skin 1 time each week while you are on study. You will be taught how to use the study drug at the first visit and will administer it to yourself at all future doses. You will continue receiving the TKI you are already taking at the dose and frequency you have been receiving it when you began taking part in this study. Study Visits: At every study visit, you will be asked about any side effects you may have had and to list any drugs you may be taking. Every 1-2 weeks for 8 weeks, then every 6-8 weeks after that, blood (about 1-2 teaspoons) will be drawn for routine tests. Every 3 months for 6 months, then every 6-12 months after that, you will have a complete physical exam, including measurement of your vital signs. Every 3-6 months for 1 year, you will have a bone marrow aspirate to check the status of the disease and to check for changes in your chromosomes. Every 3-6 months for 1 year, then every 6-12 months after that, blood (about 1 teaspoon) will be drawn to check the levels of leukemia in the blood. Length of Study: You may continue taking Pegasys for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. Pegasys is FDA approved and commercially available for the treatment of CML. TKIs (imatinib, nilotinib, and dasatinib) are FDA approved and commercially available for the treatment of CML. The combination of these drugs to treat CML is investigational. Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

Leukemia, Chronic Myeloid Leukemia, CML, Tyrosine Kinase Inhibitors, TKI, Complete cytogenetic remission, CCyR, Minimal residual disease, MRD, PEG-IFNa-2a, Pegasys, Peginterferon Alpha-2a, Philadelphia chromosome (Ph)-positive, BCR-ABL1-positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEG-IFNá-2a

Arm Type

Experimental

Arm Description

PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.

Intervention Type

Drug

Intervention Name(s)

PEG-IFNá-2a

Other Intervention Name(s)

Pegasys, Peginterferon Alpha-2a

Intervention Description

45 mcg given subcutaneously as a single weekly dose for 24 months.

Primary Outcome Measure Information:

Title

Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)

Description

Time Frame

12 months from start of treatment with PEG-IFNá-2a

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR). Patients are receiving an FDA-approved TKI for the management of CML. Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months. Patients must be in complete cytogenetic remission. Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: 1. The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. The patient has received therapy for at least 5 years and does not have a sustained complete molecular response. Patients must not have had a known continuous interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Eastern Cooperative Oncology Group (ECOG) performance status </= 2. Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and serum glutamate pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) </= 2.5x ULN. Men and women of childbearing potential should practice effective methods of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment. Exclusion Criteria: Patients receiving any non-FDA approved TKI. Patients who are pregnant or breast-feeding. Patients with clinically significant heart disease (NYHA Class III or IV).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfonso Quintas-Cardama, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Pegasys in Patients With Chronic Myeloid Leukemia (CML)

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