Trial · NCT00429416
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
NCT00429416, Phase 1, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; results first posted 2013-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT00429416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT00429416
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Conditions
- Hematologic Malignancies
- Interventions
L-leucyl-L-leucine Methyl Ester (LLME), Fludarabine, Cytarabine, Cyclophosphamide, Tacrolimus, Mesna, Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF), Hematopoietic stem cell transplantation (HSCT)
- First posted
- 2007-01-31
- Last updated
- 2016-11-29
- Results first posted
- 2013-12-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality | Through 100 days post-transplant or death | 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. |
| Secondary | Rate of Engraftment of Non-Myeloablative Transplants | Through 30 days post-transplant | Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products. |
| Secondary | Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) | Through 24 months post-treatment | Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit. |
| Secondary | Rate of Serious Infectious Complications | Through 3 months post-transplant | Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy. CD4 counts will be measured monthly for the first 3 months after transplant. |
| Secondary | Number of Patients Who Achieve a CD4 Count > 200/Micro-liters | Through 60 Days Post Transplant | Determine the number of patients who achieve a CD4 count \> 200/micro-liters by 60 days after transplant. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality | Through 100 days post-transplant or death | participants | NUMBER | |
| SECONDARY | Rate of Engraftment of Non-Myeloablative Transplants | Through 30 days post-transplant | participants | NUMBER | |
| SECONDARY | Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) | Through 24 months post-treatment | participants | NUMBER | |
| SECONDARY | Rate of Serious Infectious Complications | Through 3 months post-transplant | participants | NUMBER | |
| SECONDARY | Number of Patients Who Achieve a CD4 Count > 200/Micro-liters | Through 60 Days Post Transplant | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality | LLME to Decrease GVHD Following HSC T | 1 | participants | ||
| Rate of Engraftment of Non-Myeloablative Transplants | LLME to Decrease GVHD Following HSC T | 13 | participants | ||
| Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) | LLME to Decrease GVHD Following HSC T | Developed grade II-IV GVHD | 3 | participants | |
| Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) | LLME to Decrease GVHD Following HSC T | Developed cGVHD (Chronic GVHD) | 1 | participants | |
| Rate of Serious Infectious Complications | LLME to Decrease GVHD Following HSC T | 2 | participants | ||
| Number of Patients Who Achieve a CD4 Count > 200/Micro-liters | LLME to Decrease GVHD Following HSC T | 13 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LLME to Decrease GVHD Following HSC T | 14 | |
| Overall Study | COMPLETED | LLME to Decrease GVHD Following HSC T | 13 | |
| Overall Study | NOT COMPLETED | LLME to Decrease GVHD Following HSC T | 1 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Diarrhea | General disorders | LLME to Decrease GVHD Following HSC T | 2 | 14 | 2 |
| serious | Bone marrow cellularity | General disorders | LLME to Decrease GVHD Following HSC T | 1 | 14 | 1 |
| serious | Infection | General disorders | LLME to Decrease GVHD Following HSC T | 3 | 14 | 7 |
| serious | Pancyptopenia | General disorders | LLME to Decrease GVHD Following HSC T | 1 | 14 | 1 |
| serious | Hematoma | General disorders | LLME to Decrease GVHD Following HSC T | 1 | 14 | 1 |
| serious | Death | General disorders | LLME to Decrease GVHD Following HSC T | 7 | 14 | 7 |
| serious | Hypersensitivity | General disorders | LLME to Decrease GVHD Following HSC T | 1 | 14 | 1 |
| serious | Chest pain | General disorders | LLME to Decrease GVHD Following HSC T | 2 | 14 | 2 |
| serious | Progressive disease | General disorders | LLME to Decrease GVHD Following HSC T | 1 | 14 | 1 |
| serious | Nausea | General disorders | LLME to Decrease GVHD Following HSC T | 3 | 14 | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LLME to Decrease GVHD Following HSC T | ||
| Total, other adverse events | LLME to Decrease GVHD Following HSC T | 0 | 0 |
| Total, serious adverse events | LLME to Decrease GVHD Following HSC T | 10 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00429416
GET https://conductscience.org/api/trials/v1/NCT00429416/registered