Status:
TERMINATED
Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the be...
Detailed Description
Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups involving the dose of T-cells in the donor lymphocyte infusion. ...
Eligibility Criteria
Inclusion
- Age \>/= 18 years and \</= 65 years with 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 intermediate or high cytogenetic risk factors or flt3 mutation. 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 inhibitor treatment in a first or subsequent chronic phase, or in accelerated phase. 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 and willing to donate: a. Related donor, HLA-matched for HLA-A, -B, C and DR matched or, b. Matched Unrelated Donor (MUD), HLA-matched for HLA A, B, C and DRB1 using allele level typing.
- Performance score of at least 80% by Karnofsky or performance score 0 to 2 (ECOG).
- Estimated creatinine clearance \>40 ml/min (based on serum creatinine)
- Bilirubin \<1.5 mg/dl except for Gilbert's disease.
- ALT \< 300 IU/ml d.
- Left ventricular ejection fraction equal or greater than 40%.
- Pulmonary function test (PFT) demonstrating a diffusion capacity (corrected for hemoglobin) of least 50% predicted.
- Patient or patient's legal representative able to sign informed consent.
Exclusion
- Patients who have had prior autologous transplants or prior allogeneic transplants are not eligible.
- 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.
- Subject has known sensitivity to any of the products that will be administered during the study.
- Patients who are HIV seropositive.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01518153
Start Date
February 1 2012
End Date
August 1 2014
Last Update
March 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030