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

Recruiting at 4 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

572 Participants Needed

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

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.

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

Group I: Main Study Group A: Tac/MTX/Ruxolitnib Experimental Treatment 3 Interventions

Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.

Group II: Dose Finding Run-In Group 2: Tac/MTX/Ruxolitnib Dose 2 Experimental Treatment 3 Interventions

Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.

Group III: Dose Finding Run-In Group 1: Tac/MTX/Ruxolitnib Dose 1 Experimental Treatment 3 Interventions

Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.

Group IV: Main Study Group B: PTCy/Tac/MMF Active Control 3 Interventions

Post-transplant cyclophosphamide/ tacrolimus/ mycophenolate mofetil (PTCy/Tac/MMF) at the protocol defined doses.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

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+