Clinical trial · Interventional
Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Halted due to high incidence of veno-oclusive disease of the liver.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mycophenolate Mofetil (MMF) | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thymoglobulin + Sirolimus + MMF
- description
- Thymoglobulin 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.
- interventionNames
- Drug: Mycophenolate Mofetil (MMF)
- Drug: Thymoglobulin
- Drug: Sirolimus
- Procedure: Stem Cell Transplant
Primary outcomes (2)
- measure
- Failure Rate
- timeFrame
- Baseline to 100 days post transplant
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority. 3. Age 18-75 years. 4. Bilirubin \</=1.5 mg/dl, serum glutamic-pyruvic transaminase (SGPT) \</= 200 IU/ml. 5. Creatinine \</=1.6 mg/dl. Exclusion Criteria: 1. Regimens including rituximab or alemtuzumab in the preparative regimen. 2. Patients can not have received prior treatment with gemtuzumab. 3. Planned conditioning chemotherapy for transplant can not include gemtuzumab. 4. Planned conditioning chemotherapy for transplant can not include the busulfan and cyclophosphamide regimen. 5. HIV seropositivity 6. Uncontrolled infection, not responding to adequate antimicrobial therapy after 7 days of treatment. The protocol PI is the final arbiter of eligibility. 7. Pregnancy 8. Inability to sign consent. 9. Patients who are past recipients of allogeneic or autologous stem cell transplants from any source.
References
Publications (0)
Data not yet available