Myelofibrosis Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis
The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.
This is a Phase 3, randomized, double-blind study of the combination of the PI3Kδ inhibitor parsaclisib or matching placebo and the JAK1/2 inhibitor ruxolitinib in participants with PMF or secondary MF (PPV-MF or PET-MF) with DIPSS risk category of intermediate or high. Prospective participants must have not received prior MF therapy with a JAK inhibitor or a PI3K inhibitor. After participants have been determined to be eligible for the study and completed the baseline symptom diary assessment for 7 days, they will be randomized to 1 of 2 treatment groups, with stratification for platelet count (≥ 100 × 10^9/L vs 50 to < 100 × 10^9/L inclusive) and DIPSS risk category (high vs intermediate-2 vs intermediate-1). Once all enrolled participants completed the week 24 assessments the study will be unblinded and and participants randomized to placebo will have the opportunity to cross over to begin receiving parsaclisib, together with continued ruxolitinib, as long as hematology parameters are adequate. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Terminated |
NCT04866056 -
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
|
Phase 1/Phase 2 | |
| Active, not recruiting |
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 |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| 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 |
NCT00997386 -
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
|
Phase 2 | |
| 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 |
NCT00666549 -
Research Tissue Bank
|
||
| Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
| Terminated |
NCT00393380 -
Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
|
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 | |
| Recruiting |
NCT04988815 -
Ropeginterferon Alfa 2b for Early Myelofibrosis
|
Phase 2 | |
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
| Active, not recruiting |
NCT02530619 -
Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
|
N/A | |
| Completed |
NCT04153305 -
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
|