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Study Summary
No. 2003-0564:.......Blood And Marrow Transplantation......Muzaffar H. Qazilbash......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2003-0564
Study Title:A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients with recurrent CML after Allogeneic Hematopoietic Transplantation
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Physician New Patient Referral
Name:Muzaffar H. QazilbashPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4326
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow TransplantationSupported By:N/A
Phase of Study:Phase IReturn
Visit:
Every week for first 4 weeks, then every month for 6 months after the last
PR1-CTL infusion, then q 3 months until 1 year
Treatment
Agents:
PR1Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
28 days
Description/
Intervention:
The goal of this clinical research study is to find the highest safe dose of
cells donated form a donor that can be given to treat leukemia in patients with
CML.
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Study Objectives / Outcomes
Primary objective: to determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent CML after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.

Secondary objectives:

1. To evaluate the immunological response following PR1-CTL treatment

2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months
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Study Status Information
Study Activation / Registration Date:03/20/2009
IRB Review and Approval Date:02/20/2004
Study Type:
Recruitment Status:Closed
Projected Accrual:30
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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 with CML who have previously undergone allogeneic hematopoietic transplantation and have evidence of disease, as defined by a,b or c (a) >5% Philadelphia chromosome positive cells on cytogenetic studies >/= 3 months post-transplant

2) (b) For patients in cytogenetic remission post-transplant, molecular evidence of disease at any time, defined as recurrence of quantitative PCR positivity for bcr-abl after achieving a molecular remission confirmed by 2 assays, 3 months apart or sooner if clinically indicated; OR a >10-fold increase in the relative expression of bcr-abl/abl detected and confirmed by a minimum of 2 consecutive PCR analysis, 3 months apart or sooner

3) (c) Molecular evidence of persistent disease on Real time PCR (bcr-abl/ abl x 100 of 0.05 and not declining) >3 months post-transplantation after treatment with imatinib mesylate.

4) Patients must have an HLA compatible related or unrelated donor capable of donating peripheral blood stem cells using apheresis techniques. This must be the same donor used for the original allogeneic hematopoitic transplantation. Patient must be HLA-A2 positive

5) ECOG performance status < or = 2

6) Serum bilirubin < or = 2 mg/dl

7) Serum transaminases < 4 x normal

8) Serum creatinine < or = 2 mg/dl

9) No active uncontrolled infection

10) HIV negative

11) No acute and/or chronic GVHD requiring systemic steroid therapy

12) Patient is not pregnant or breast feeding.

13) Signed informed consent

14) Patients must be off all immunosuppressive medications for at least 2 weeks prior to study entry.

Exclusion Criteria:1) None

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Links
Registration Number: NCT00866346
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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