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Anti-metabolites

Ruxolitinib + Tacrolimus + Methotrexate for Graft-versus-Host Disease Prevention in Leukemia

Phase 2

Recruiting

Led By Haris Ali

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status: Karnofsky ≥ 60% for patients ≥ 16 years old OR Lansky status ≥ 60% for patients < 16 years old

Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 from prior anti-cancer therapy

Must not have

Autologous stem cell transplant within 1 year prior to day 1 of protocol therapy

Prior allogeneic transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 2 years post hct transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a medication & 2 drugs can prevent graft vs host disease in young cancer patients undergoing transplants.

Who is the study for?

This trial is for pediatric and young adult patients aged 2-22 with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome who are in remission and planning to undergo a bone marrow transplant. They must be generally healthy with an ECOG ≤ 2 or Karnofsky/Lansky status ≥ 60%, have a matched donor, not be pregnant, agree to birth control measures, and have no recent history of certain severe health issues.

What is being tested?

The trial tests if ruxolitinib combined with tacrolimus and methotrexate can prevent graft versus host disease after allogeneic hematopoietic cell transplantation. Ruxolitinib is a kinase inhibitor that may reduce inflammation; tacrolimus suppresses the immune system to lower rejection risk; methotrexate stops DNA production which might also help prevent GVHD.

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, potential liver or kidney problems due to tacrolimus, mouth sores from methotrexate, and general side effects like nausea or fatigue. Ruxolitinib could cause blood count changes or increase the risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself and carry out daily activities.

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I have recovered from side effects of cancer treatment, except for hair loss.

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I am between 2 and 22 years old.

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I can perform all my self-care but may not be able to work.

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I am eligible for a bone marrow transplant and have a matching donor.

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I have acute leukemia or MDS and am in complete remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant using my own cells within the last year.

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I have had a transplant from another person.

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I am currently taking herbal medications.

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I have had a clot-related event like a heart attack or stroke in the last 6 months.

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

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I do not have an ongoing serious infection needing antibiotics.

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I have a history of HIV or hepatitis B/C.

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I have had active tuberculosis in the past.

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I do not have any uncontrolled serious illnesses.

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I am not pregnant or breastfeeding.

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I do not have any other active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of transplantation to the first time of observing the following events: grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death, assessed at 1 year post transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of transplantation to the first time of observing the following events: grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death, assessed at 1 year post transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of transplantation to the first time of observing the following events: grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death, assessed at 1 year post transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Graft-versus-host disease (GVHD)-free and relapse-free (GRFS)

Incidence of adverse events

Secondary study objectives

Hematologic recovery, donor cell engraftment and immune reconstitution

Incidence of acute GVHD

Incidence of adverse events during phase II segment

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (Ruxolitinib, tacrolimus, methotrexate)Experimental Treatment8 Interventions

Patients receive ruxolitinib PO BID from day -1 to day +100, tacrolimus IV on day -1, and methotrexate IV on days +1, +3, +6, and +11, and undergo HCT on day 0. Patients also undergo chest CT and ECHO/MUGA at screening and undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

2019

Completed Phase 4

~5510

Biospecimen Collection

2004

Completed Phase 3

~2020