Status:
COMPLETED
Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies
Lead Sponsor:
Robert Lowsky
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor periphe...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of purifying allogeneic CD8+ memory T-cells suitable for clinical application and to determine the safety and maximum tolerated dose (MTD) of these...
Eligibility Criteria
Inclusion
- Patients must have undergone a human leukocyte antigen (HLA) matched (sibling) allogeneic HCT for a hematologic or lymphoid malignancy other than chronic myelogenous leukemia (CML) who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1x10\^8cells/kg will be eligible for CD8+ memory T cell infusion
- Patients must have no evidence of active graft-versus-host disease and must be on a stable immunosuppressive regimen without a change in drugs dosage in the 4 weeks prior to the planned CD8+ memory T cell infusion
- Patients must not have any active infections
- Patients must have a performance status of \> 70% on the Karnofsky scale
- Serum creatinine of \< 2 mg/dl or creatinine clearance of \> 50 cc/min
- Bilirubin of \< 3 mg/dl Transaminases \< 3 times the upper limit of normal
- Patients must have negative antibody serology for the human immunodeficiency virus (HIV1 and 2) and hepatitis C virus and negative test for hepatitis B surface antigen
- DONOR:
- Donors must be an HLA matched sibling
- Donors must be 18-75 years of age, inclusive
- Donors must be in a state of general good health
- Donors must have a white blood cell count \> 3.5 x 10\^9/liter DONOR: Platelets \> 150 x 10\^9/liter
- Donors: Hematocrit \> 35%
- Donors must be capable of undergoing leukapheresis
- Donors must not be seropositive for HIV 1 and 2, Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, human T-lymphotropic virus (HTLV) antibody, cytomegalovirus (CMV) immunoglobulin (Ig)M, or Rapid Plasma Reagin (RPR) (Treponema)
- Female donors must not be pregnant or lactating
Exclusion
- Diagnosis of CML except patients who have failed prior donor leukocyte infusion with a minimum cell dose of 1x10\^8 cells/kg
- Patients who have been diagnosed with a second cancer (except carcinoma in situ of the cervix and basal cell carcinoma of the skin) which is currently active or has been treated within three years prior to screening
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01523223
Start Date
January 1 2012
End Date
October 1 2016
Last Update
November 22 2023
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305