Itacitinib + Tacrolimus + Sirolimus for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byHaris Ali

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoing reduced intensity conditioning donor stem cell transplantation. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation.

Research Team

Haris Ali

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with acute leukemia, myelodysplastic syndrome, or myelofibrosis planning to undergo stem cell transplantation. Participants need a matched donor, good organ function, and must not be pregnant or breastfeeding. They should agree to use birth control and cannot have other active cancers or uncontrolled illnesses.

Inclusion Criteria

My lung function tests are good or my oxygen levels are above 92% without extra oxygen.

All candidates for this study must have a matched related donor (MRD) who is willing to donate BM or peripheral blood stem cells or an 8/8 allele matched unrelated donor (MUD)

Note: To be performed within 28 days prior to day 1 of protocol therapy

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Exclusion Criteria

I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.

You have had allergic reactions in the past to drugs that are similar to the study medication.

I have ongoing diarrhea because of a bowel condition or absorption issue.

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Treatment Details

Interventions

Itacitinib Adipate (Janus Kinase (JAK) Inhibitor)
Sirolimus (Immunosuppressant)
Tacrolimus (Immunosuppressant)

Trial OverviewThe study tests if adding Itacitinib to standard GVHD prevention drugs Tacrolimus and Sirolimus can better prevent graft-versus-host disease in patients receiving reduced intensity conditioning donor stem cell transplants. The effectiveness of this combination will also be assessed through quality-of-life questionnaires.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (itacitinib adipate, tacrolimus, sirolimus)Experimental Treatment7 Interventions

RIC: Patients receive fludarabine via infusion on days -9 to -5 and melphalan on day -4 in the absence of disease progression or unacceptable toxicity. ALLOGENEIC HSCT: Patients undergo HSCT on day 0. GVHD PROPHYLAXIS: Patients receive itacitinib PO QD beginning on day -3 and continuing until day 100 in the absence of disease progression or unacceptable toxicity. Patients also receive tacrolimus IV or PO and sirolimus PO beginning day -3 and continuing until day 100 with a taper in the absence of disease progression or unacceptable toxicity.