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A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Pediatric Leukemia

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent
chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the
study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy
regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the
recommended dose determined in Part 1.
Pediatric Leukemia
II
Friedman, Debra
NCT02723994
VICCPED16131

Ruxolitinib Phosphate in Treating Older Patients with Acute Myeloid Leukemia in Complete Remission or Myelodysplastic Syndrome after Donor Stem Cell Transplant

Multiple Cancer Types

This phase II trial studies how well ruxolitinib phosphate works in treating older patients with acute myeloid leukemia in complete remission or myelodysplastic syndrome after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Hematologic, Leukemia
II
Dholaria, Bhagirathbhai
NCT03286530
VICCCTT1778

Ruxolitinib Phosphate before and after Stem Cell Transplant in Treating Patients with Primary or Secondary Myelofibrosis

Hematologic

This phase II trial studies how well ruxolitinib phosphate before and after stem cell transplant works in treating patients with primary or secondary myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patients immune cells and help destroy any remaining cancer cells.
Hematologic
II
Oluwole, Olalekan
NCT03427866
VICCCTT1863

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Miscellaneous

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and
tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
combination with ruxolitinib in participants with MF who are transfusion-dependent or
presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and
expansion.
Miscellaneous
I/II
Mohan, Sanjay
NCT04455841
VICCHEMP2051

A Study to Evaluate Safety and Efficacy of Selinexor in Combination With Ruxolitinib in Participants With Myelofibrosis

Multiple Cancer Types

This is a global, Phase 1/2, multicenter, open-label study to evaluate the safety and
efficacy of selinexor plus ruxolitinib in treatment nave myelofibrosis (MF) participants.
The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a of the study
will be dose escalation (non-randomized dose finding study) to determine the maximum
tolerated dose [MTD], recommended Phase 2 dose (RP2D), and evaluate safety and preliminary
efficacy and will follow a standard 3+3 design. The Phase 1b of the study will be dose
expansion (non-randomized efficacy exploration) at the determined RP2D to further assess the
safety and preliminary efficacy at this dose level. The Phase 2 (randomized efficacy
exploration) of the study will include MF participants who are treatment nave randomized 1:1
to receive the combination therapy of selinexor and ruxolitinib versus (vs) ruxolitinib
monotherapy.
Hematologic, Phase I
I/II
Mohan, Sanjay
NCT04562389
VICCHEMP2130