Study Stopped
Halted due to high incidence of veno-oclusive disease of the liver.
Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
1 other identifier
interventional
13
1 country
1
Brief Summary
The goal of this clinical research study is to learn if the combination of rabbit anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug combination will also be studied. Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin, sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from human leukocyte antigen (HLA) identical related or unrelated donors. Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 20, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedSeptember 24, 2020
September 1, 2020
4.1 years
July 20, 2007
January 7, 2014
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Failure Rate
Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).
Baseline to 100 days post transplant
Number of Participants With Acute Graft-versus-host Disease (aGVHD)
Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).
Baseline to 100 days post transplant
Study Arms (1)
Thymoglobulin + Sirolimus + MMF
EXPERIMENTALThymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
Interventions
15 mg/kg by vein or by mouth every 12 hours.
1.5 mg/kg by vein daily for 4 days
6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
Stem cell infusion on Day 0.
Eligibility Criteria
You may qualify if:
- Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse. High risk hematological malignancies include: Acute myelogenous or lymphocytic leukemia with induction failure of after relapse, myelodysplastic syndrome of intermediate and high risk according to Greenberg criteria, chronic myelogenous leukemia in accelerated phase or blast crisis, non-Hodgkin's and Hodgkin's lymphoma with induction failure or relapse after chemotherapy and refractory or relapsed chronic lymphocytic leukemia.
- HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
- Age 18-75 years.
- Bilirubin \</=1.5 mg/dl, serum glutamic-pyruvic transaminase (SGPT) \</= 200 IU/ml.
- Creatinine \</=1.6 mg/dl.
You may not qualify if:
- Regimens including rituximab or alemtuzumab in the preparative regimen.
- Patients can not have received prior treatment with gemtuzumab.
- Planned conditioning chemotherapy for transplant can not include gemtuzumab.
- Planned conditioning chemotherapy for transplant can not include the busulfan and cyclophosphamide regimen.
- HIV seropositivity
- Uncontrolled infection, not responding to adequate antimicrobial therapy after 7 days of treatment. The protocol PI is the final arbiter of eligibility.
- Pregnancy
- Inability to sign consent.
- Patients who are past recipients of allogeneic or autologous stem cell transplants from any source.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A decision to terminate this trial was made due to the high incidence of veno-occlusive disease of the liver in participants receiving this graft-versus-host disease (GVHD) prophylaxis regimen.
Results Point of Contact
- Title
- Amin Alousi, MD /Professor, Stem Cell Transplantation
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amin Alousi, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2007
First Posted
July 25, 2007
Study Start
September 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
September 24, 2020
Results First Posted
February 20, 2014
Record last verified: 2020-09