MDACC Study Summary 2011-0184

Study Summary
No. 2011-0184:.......Leukemia......Alfonso Quintas-Cardama......Leukemia

Study Summary Title



Study Summary Number:	2011-0184

Study 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

Physician

New Patient Referral



Name:	Alfonso Quintas-Cardama	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4009 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Peginterferon Alpha-2a	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:

Description/
Intervention:

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.

Study Objectives / Outcomes

Primary Objectives
1. To determine the clinical activity of adding PEG-IFNa-2a to ongoing a tyrosine kinase inhibitor (TKI) therapy in patients with CML in complete cytogenetic remission (CCyR) but still harboring minimal residual disease (MRD).

Secondary Objectives
1. To determine the safety of adding PEG-IFNa-2a to ongoing TKI therapy in patients with CML in CCyR with MRD.

2. To investigate the effect of PEG-IFNa-2a on anti-CML T cell immunity and its correlation with molecular response during PEG-IFNa-2a therapy.

3. To explore the effect of the addition of PEG-IFNa to TKI therapy on the growth of clonal BCR-ABL1-positive cells.

4. To explore the effect of the addition of PEG-IFNa to TKI therapy on microRNA (miR) expression in bone marrow cells

Exploratory Objectives
1. To investigate the long-term outcome of patients in whom, after achieving a complete molecular response (CMR) on PEG-IFNa-2a, TKI therapy is discontinued.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/28/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).

2) Patients are receiving an FDA-approved TKI for the management of CML.

3) Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.

4) Patients must be in complete cytogenetic remission.

5) 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.

6) 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.

7) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

8) ECOG performance status </= 2.

9) Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and sGPT or sGOT </= 2.5x ULN.

10) 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:

1) Patients receiving any non-FDA approved TKI.

2) Patients who are pregnant or breast-feeding.

3) Patients with clinically significant heart disease (NYHA Class III or IV).

Links

Registration Number: NCT01392170
Study Information on Clinical Trials Registry (clinicaltrials.gov)