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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 transplantation

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: Cyclophosphamide; Cytarabine; Fludarabine; Fludarabine phosphate; Mesna; Molgramostim; Sargramostim; Tacrolimus; Vidarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.