PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation

NCT00866346 | Withdrawn Phase 1

• 2 other identifiers: 2003-0564NCI-2012-01651
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor. Secondary Objectives:

1. 1.To evaluate the immunological response following PR1-CTL treatment
2. 2.To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months

Conditions

Chronic Myelogenous Leukemia

Keywords

Chronic Myelogenous Leukemia; CML; Allogeneic Hematopoietic Transplantation; Bone Marrow Transplant; PR1-Specific Cytotoxic T-Lymphocyte Infusion

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL)

  Continuous reassessment, infusion day 0 and second infusion day 60+/- 7

Study Arms (1)

PR1-CTL

EXPERIMENTAL

Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg.

Biological: PR1-primed lymphocyte (PR1-CTL) Infusion

Interventions

PR1-primed lymphocyte (PR1-CTL) Infusion BIOLOGICAL

Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg.

Also known as: AHT, Allogenic Hemotopoietic Transplantation, PR1-CTL

PR1-CTL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic myelogenous leukemia (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
• (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
• (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.
• 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 hematopoetic transplantation. Patient must be HLA-A2 positive
• ECOG performance status \< or = 2
• Serum bilirubin \< or = 2 mg/dl
• Serum transaminases \< 4 x normal
• Serum creatinine \< or = 2 mg/dl
• No active uncontrolled infection
• HIV negative
• No acute and/or chronic GVHD requiring systemic steroid therapy
• Patient is not pregnant or breast feeding.
• Signed informed consent
• Patients must be off all immunosuppressive medications for at least 2 weeks prior to study entry.

You may not qualify if:

• None.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muzaffar H. Qazilbash, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Richard E. Champlin, MD, BS

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 20, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2015
• Last Updated: March 4, 2014

Record last verified: 2014-03