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Alkylating agents

Cyclophosphamide + Ruxolitinib for Graft-versus-Host Disease Prophylaxis

Phase 2

Recruiting

Led By Sameem Abedin, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after hct

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at safety/effectiveness of low-dose drug to prevent transplant-related side effects in older adults getting a stem cell transplant.

Who is the study for?

Adults with certain blood cancers who are in remission can join this trial if they have a matched stem cell donor and meet health criteria like good performance status, normal organ function, and no recent other cancers. They must agree to contraception use.

What is being tested?

The study tests a combination of low-dose Cyclophosphamide (PTCy) and Ruxolitinib for preventing GVHD in older adults receiving stem cell transplants from matched donors, using reduced intensity conditioning therapy.

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, bleeding complications, liver toxicity, gastrointestinal issues such as nausea or diarrhea, and potential drug-specific reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after hct for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The number of subjects who experience GVHD-free survival.

Secondary study objectives

Overall survival at one year.

The number of subjects with acute GVHD at Day +100.

The number of subjects with acute GVHD at Day +180.

+3 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: Graft-versus-host disease prophylaxisExperimental Treatment4 Interventions

Following reduced intensity conditioning and 8/8-matched peripheral blood transplant on Day 0, all patients will receive a GVHD prophylaxis post-transplant composed of the following: (i) cyclophosphamide administered at 25 mg/kg on Day +3 and +4, (ii) tacrolimus beginning on Day +5 and through Day +180 and administered with a trough target of 5-10 ng/ml through Day +90 and tapered thereafter; (iii) mycophenolate mofetil (MMF) administered at 15 mg/kg thrice daily beginning on Day +5 through Day +35; and (iv) ruxolitinib administered at 5 mg twice daily starting after engraftment (between Days +30 and +60) and continuing through one year post transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Tacrolimus

2019

Completed Phase 4

~5510