Myelofibrosis Clinical Trial
Official title:
Pilot Safety and Feasibility Trial of Mycophenolate and Sirolimus for Prevention of GVHD in Mismatched Unrelated and Related Donor Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such as sirolimus and mycophenolate mofetil, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be better in preventing graft-versus-host disease.
PRIMARY OBJECTIVES:
I. Evaluate the safety and feasibility of administering sirolimus and mycophenolate mofetil
(MMF) as prophylaxis of grade III-IV acute graft versus host disease (aGvHD) in patients
undergoing mismatched unrelated and related donor hematopoietic stem cell transplant (HSCT).
OUTLINE:
Patients receive sirolimus orally (PO) starting on day -3, 3 times a week during
hospitalization and then once a week for up to 6 months. Patients undergo HSCT on day 0.
Patients also receive mycophenolate mofetil intravenously (IV) or PO three times a day (TID)
on days 1-180. Treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up at days 30, 60, 100, 180, 270,
and 365, and then yearly thereafter.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
Not yet recruiting |
NCT06345495 -
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
|
Phase 2 | |
Terminated |
NCT04866056 -
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
|
Phase 1/Phase 2 | |
Completed |
NCT02784496 -
Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
|
Phase 2 | |
Completed |
NCT00069680 -
Genetic Analysis of Gray Platelet Syndrome
|
||
Active, not recruiting |
NCT04097821 -
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03289910 -
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
|
Phase 2 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Not yet recruiting |
NCT06397313 -
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
|
Phase 2 | |
Not yet recruiting |
NCT06024915 -
A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
|
Phase 1 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT02910258 -
Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
|
||
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00997386 -
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
|
Phase 2 | |
Completed |
NCT00666549 -
Research Tissue Bank
|
||
Terminated |
NCT00393380 -
Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
|
Phase 2 | |
Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
Active, not recruiting |
NCT03952039 -
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
|
Phase 3 | |
Not yet recruiting |
NCT04709458 -
Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
|
Phase 1 |