Phase 2
Completed N=14
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
Source: ClinicalTrials.gov NCT00429416 ↗Enrolled (actual)
14
Serious AEs
71.4%
Results posted
Dec 2013
Primary outcomePrimary: Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality — 1 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality |
1 | — |
| SECONDARY Rate of Engraftment of Non-Myeloablative Transplants |
13 | — |
| SECONDARY Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) |
3; 1 | — |
| SECONDARY Rate of Serious Infectious Complications |
2 | — |
| SECONDARY Number of Patients Who Achieve a CD4 Count > 200/Micro-liters |
13 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00429416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.