Myelofibrosis Clinical Trial
Official title:
A Phase 1 Dose Escalation and Expansion Study of TGR-1202 + Ruxolitinib in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, or Polycythemia Vera Resistant to Hydroxyurea
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
The escalation will include 2 initial sequential stages. Stage 1 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients already taking therapeutic levels of ruxolitinib, but who are not achieving maximal response at the highest tolerated dose of ruxolitinib as discussed among investigators. Only TGR-1202 will be escalated in a modified 3+3 dose escalation algorithm to determine the MTD of TGR-1202 to be given with any given dose of ruxolitinib. Stage 2 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients who have never been on JAK-STAT inhibitory agents, and includes simultaneously initiation of both ruxolitinib and TGR-1202. In Stage 2, JAK Inhibitor naïve patients will receive TGR-1202 at the recommended dose established in Cohort 1, and ruxolitinib. As patients in Stage 1 will be on ruxolitinib at different doses, dose levels in Stage 2 will expand to meet requirements for safety analysis. ;
| 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 |