Clinical trial · Interventional
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
A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies
NCT00429416CI-TRIAL-00024945completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) | Biological | — | UNRESOLVED |
| Hematopoietic stem cell transplantation (HSCT) | Procedure | — | UNRESOLVED |
| L-leucyl-L-leucine Methyl Ester (LLME) | Drug | — | UNRESOLVED |
| Mesna | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LLME to Decrease GVHD Following HSC T
- description
- To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
- interventionNames
- Drug: L-leucyl-L-leucine Methyl Ester (LLME)
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: Cyclophosphamide
- Drug: Tacrolimus
- Drug: Mesna
- Biological: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
- Procedure: Hematopoietic stem cell transplantation (HSCT)
Primary outcomes (1)
- measure
- Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality
- timeFrame
- Through 100 days post-transplant or death
- description
- Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events. This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.