Status:
COMPLETED
Research Study to Determine if an Experimental Agent, LLME Can Decrease the Incidence and Severity of Graft-Versus-Host-Disease (GVHD) Following Blood (Hematopoietic) Stem Cell Transplantation
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to determine if an experimental agent, LLME can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following blood (hematopoietic) stem cell ...
Detailed Description
We believe that the risks of allogeneic transplant can be drastically reduced if the following criteria can be met: (1) consistent engraftment, (2) little or no GVHD with the ability to rapidly withdr...
Eligibility Criteria
Inclusion
- Patients must be \> 18 years of age, with no upper age limit.
- Patients must have an ECOG performance status of 0 or 1.
- Any patient with a hematologic malignancy which is unlikely to be cured by conventional treatment is eligible for this study.
- Patients for whom a disease specific protocol exists will be transplanted on those protocols as discussed in the introduction.
- Patients who have had prior autografts may be treated on this protocol.
- Patients must have adequate physical function as measured by the following criteria:
- Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be \>40%.
- Hepatic: Aspartate transaminase (AST) micro 3x the upper limits of normal and total serum bilirubin \< 2.5 mg/dL. Patients with a higher bilirubin from "benign conditions" such as Gilbert's disease may still be eligible for the study.
- Renal: Serum creatinine within the normal range or if creatinine outside normal range then creatinine clearance \> 60 ml/min/1.73m2. Serum creatinine must be less than or equal to 2.0 mg/dl.
- Pulmonary: Asymptomatic or, if symptomatic, DLCO (diffusion capacity) \> 45% of predicted (corrected for hemoglobin)
- The patient or guardian(s) must be able to give informed consent to the study.
- Patient must have a suitable donor who is identical for HLA (human leukocyte antigens) -A, -B, -C, -DR. Single antigen mismatches for HLA-A, -B, -C, -DR are also permitted. Donors obtained through the National Marrow Donor Program (NMDP) will follow NMDP guidelines.
Exclusion
- Patients who are eligible for a standard myeloablative transplant and for whom a standard myeloablative transplant is preferable will not be treated on this protocol.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00429416
Start Date
March 1 2004
End Date
May 1 2009
Last Update
November 29 2016
Active Locations (1)
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1
Thomas Jefferson University'
Philadelphia, Pennsylvania, United States, 19107