Ruxolitinib + Stem Cell Transplant for Myelofibrosis

Phase 2

Recruiting

Led By Uday Popat, MD

Research Sponsored by M.D. Anderson Cancer Center

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 through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using ruxolitinib and busulfan before a stem cell transplant can shrink the spleen and improve the success of the transplant.

Who is the study for?

This trial is for myelofibrosis patients with an enlarged spleen. Participants should be eligible for a stem cell transplant and able to take medications like ruxolitinib and busulfan. Specific eligibility details are not provided, but typically include age range, overall health status, and disease stage.

What is being tested?

The study tests if high doses of ruxolitinib followed by chemotherapy (busulfan) can shrink the spleen before a stem cell transplant in myelofibrosis patients. The goal is to see if this approach improves transplant success.

What are the potential side effects?

Possible side effects may include immune system suppression, infection risk increase due to the stem cell transplant process, medication-related issues such as nausea or liver problems from ruxolitinib or busulfan, and potential complications from other drugs used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

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: Ruxolitinib and Allogeneic Stem Cell TransplantationExperimental Treatment10 Interventions

Participants will be asked to receive study drugs and a stem cell transplant and attend study visits, at which various tests and procedures will be performed. Participants are expected to receive treatment for about 100 days, followed by a year of follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesna

2003

Completed Phase 2

~1380

Tacrolimus

2019

Completed Phase 4

~5510