572 Participants Needed

Tacrolimus/Methotrexate/Ruxolitinib vs Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil for Graft-versus-Host Disease

Recruiting at 4 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Incyte Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Research Team

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for adults over 18 with certain blood cancers like acute leukemia, myelodysplasia, or lymphoma without high levels of cancer cells in the blood or bone marrow. They must have a functioning heart and kidneys. Participants need a sibling or unrelated donor who matches specific genetic markers and agrees to donate stem cells.

Inclusion Criteria

My sibling, child, or parent is a perfect match for my stem cell transplant.
My leukemia has minimal presence in my blood and bone marrow.
My blood disorder has less than 10% immature cells in my bone marrow.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants undergo non-myeloablative/reduced intensity conditioning prior to transplantation

1-2 weeks

Transplantation

Participants receive allogeneic peripheral blood stem cell transplantation

1 day

Treatment

Participants receive Tacrolimus/Methotrexate/Ruxolitinib or Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

  • Cyclophosphamide
  • Methotrexate
  • Mycophenolate mofetil
  • Ruxolitinib
  • Tacrolimus
Trial Overview The study compares two drug combinations after non-myeloablative/reduced intensity conditioning allogeneic peripheral blood stem cell transplantation. One group receives Tacrolimus/Methotrexate/Ruxolitinib, while the other gets Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Main Study Group A: Tac/MTX/RuxolitnibExperimental Treatment3 Interventions
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Group II: Dose Finding Run-In Group 2: Tac/MTX/Ruxolitnib Dose 2Experimental Treatment3 Interventions
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Group III: Dose Finding Run-In Group 1: Tac/MTX/Ruxolitnib Dose 1Experimental Treatment3 Interventions
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Group IV: Main Study Group B: PTCy/Tac/MMFActive Control3 Interventions
Post-transplant cyclophosphamide/ tacrolimus/ mycophenolate mofetil (PTCy/Tac/MMF) at the protocol defined doses.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Blood and Marrow Transplant Clinical Trials Network

Collaborator

Trials
51
Recruited
14,600+
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