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This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol.
MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Arm | Experimental | Omission of the drug mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omission of the drug mycophenolate mofetil | Other | Elimination of the immunosuppressive drug mycophenolate mofetil (MMF) from the post-transplant regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment failure | Evaluate the feasibility of eliminating the drug Mycophenolate Mofetil (MMF) from the transplant regimens as determined by an acceptable rate of engraftment failure (<10%). Engraftment failure is when the blood-forming cells received on transplant day do not start to grow and make healthy blood cells. | 60 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neutrophil and platelet engraftment | Days to neutrophil and platelet engraftment since transplant. | 60 days post-transplant |
| Rate of severe acute GVHD by day +100. | Proportion of patients with severe acute GVHD at day 100 post-transplantation.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Paquette, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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Open-label safety trial
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| 100 days post-transplant |
| Treatment-related mortality | Rate of treatment-related mortality | 5 days post- transplant to 2-years |
| Rate of severe chronic GVHD at 1 year | Proportion of patients with severe chronic GVHD at day 365 post-transplantation. -Chronic GVHD is when the donated stem cells attack the body after 100 days post-transplant. Chronic GVHD is defined by NIH Consensus Criteria for chronic GVHD. | 1-year post-transplant |
| Relapse | Relapse rate at 1 and 2 years | 1 year post-transplant and 2 years post-transplant |
| Overall Survival (OS) | Overall survival at 1 and 2 years | 1-year post-transplant and 2-years post-transplant |
| Graft Versus Host Disease (GVHD)-free, Relapse Free Survival | Rate of GVHD-free, Relapse Free Survival | 1-year post- transplant and 2-years post-transplant |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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