Status:
TERMINATED
Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bellicum Pharmaceuticals
Conditions:
Leukemia
Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving genetically changed immune cells, called T-cells, after chemotherapy will improve the response to a stem cell transplant. The safety of t...
Detailed Description
Gene Transfer: Gene transfer involves drawing blood from a transplant donor, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, ...
Eligibility Criteria
Inclusion
- Age \>/= 18 years and \</= 65 years.
- One of the following: a. Acute leukemia past first remission, in first or subsequent relapse, in second or greater remission. Patients in first remission should have with intermediate or high cytogenetic risk factors or flt3 mutation. Patients with relapsed disease. Patients with primary induction failure or relapse are eligible if they have \< 10% bone marrow blasts, and no circulating blasts. b. Myelodysplastic syndrome with intermediate or high risk IPSS score, or treatment related MDS. c. CML resistant to tyrosine kinase treatment in a first or subsequent chronic phase or after transformation to accelerated phase or blast crisis.
- 2 (continued): d. CLL, Lymphoma or Hodgkin's disease which has failed to achieve remission or recurred following initial chemotherapy. Patients must have at least a PR to salvage therapy, or low bulk untreated relapse (\< 2 cm largest mass). e. Multiple myeloma which has relapsed or progressed and has achieved a partial response to salvage chemotherapy.
- Patients must have one of the following donor types identified who are willing to donate peripheral blood: a. Related donor, 8/8 HLA-matched for HLA-A, -B, C and DR matched or, b. Matched Unrelated Donor (MUD), 8/8 HLA-matched for HLA A, B, C and DRB1 using allele level typing.
- Performance score of at least 80% by Karnofsky.
- Adequate major organ system function as demonstrated by: a. Creatinine \< 1.8 mg/dl (or creatinine clearance \> 40 ml/min) b. Bilirubin \< 1.5 mg/dl except for Gilbert's disease c. ALT \< 300 IU/ml d. Left ventricular ejection fraction equal or greater than 40%. e. Pulmonary function test (PFT) demonstrating a diffusion capacity of least 50% predicted, corrected for hemoglobin.
- Patient or patient's legal representative, able to sign informed consent.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study 2006-0676.
- The patient will need to be available for evaluation within 72 hours of symptoms of GVHD, occurring within 60 days of the planned donor lymphocyte infusion.
Exclusion
- Uncontrolled active infection.
- Positive Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Women of child bearing potential not willing to use an effective contraceptive measure while on study.
- Men not willing to use an effective contraception method while on study.
- Known sensitivity to any of the products that will be administered during the study.
- HIV seropositive.
- Prior allogeneic transplant.
Key Trial Info
Start Date :
December 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01875237
Start Date
December 27 2013
End Date
March 7 2017
Last Update
July 16 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030