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Anti-metabolites

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

Q: What prerequisites must individuals fulfill in order to be eligible for this clinical trial?

To be considered for entry to this trial, patients should possess <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> and range in age from 2-22 years old. The study is aiming to enroll a total of 40 participants.

Q: Is the age requirement for this research trial greater than 35 years?

The inclusion requirements of this trial stipulate that the participant's age must be between 2 and 22 years old.

Q: Are any fresh applicants being admitted into this trial?

As per the information on clinicaltrials.gov, this research project is no longer taking participants. The trial was first posted in January of 2024 and most recently revised in November 2023; however, there are over 3000 other studies actively looking for test subjects at present.

Q: What sort of risk is associated with employing Prevention (Ruxolitinib, tacrolimus, methotrexate) in medical treatments?

There is some evidence demonstrating the safety of Prevention (Ruxolitinib, tacrolimus, methotrexate), so it garnered a rating of 2. No data exists to support its efficacy yet.

Phase 2

Waitlist Available

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

Timeline

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 2 years post hct transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 2 years post hct transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years post hct transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Incidence of adverse events

Secondary outcome measures

Acute GVHD biomarkers

Hematologic recovery, donor cell engraftment and immune reconstitution

Incidence of acute GVHD

+11 more

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

2011

Completed Phase 4

~4740

Biospecimen Collection

2004

Completed Phase 2

~1730

Chest Computed Tomography

2021

N/A

~70

Ruxolitinib Phosphate

2011

Completed Phase 2

~390

Hematopoietic Cell Transplantation

2006

Completed Phase 2

~360

Echocardiography

2013

Completed Phase 4

~11670

Methotrexate

2013

Completed Phase 4

~3800

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,113 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,420 Total Patients Enrolled

Haris AliPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

77 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prerequisites must individuals fulfill in order to be eligible for this clinical trial?

"To be considered for entry to this trial, patients should possess acute lymphoblastic leukemia and range in age from 2-22 years old. The study is aiming to enroll a total of 40 participants."

Answered by AI

Is the age requirement for this research trial greater than 35 years?

"The inclusion requirements of this trial stipulate that the participant's age must be between 2 and 22 years old."

Answered by AI

Are any fresh applicants being admitted into this trial?

"As per the information on clinicaltrials.gov, this research project is no longer taking participants. The trial was first posted in January of 2024 and most recently revised in November 2023; however, there are over 3000 other studies actively looking for test subjects at present."

Answered by AI

What sort of risk is associated with employing Prevention (Ruxolitinib, tacrolimus, methotrexate) in medical treatments?

"There is some evidence demonstrating the safety of Prevention (Ruxolitinib, tacrolimus, methotrexate), so it garnered a rating of 2. No data exists to support its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

2024. "Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128070.

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