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Chemotherapy

Ruxolitinib and Allogeneic Stem Cell Transplantation for Enlarged Spleen

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Safety and adverse events (AEs)

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

Ruxolitinib

2018

Completed Phase 3

~1140

Allogeneic Stem Cell Transplantation

2002

Completed Phase 3

~780

Levetiracetam

2017

Completed Phase 4

~3990

Romiplostim

2015

Completed Phase 3

~2290

Eltrombopag

2013

Completed Phase 4

~970

Busulfan

2008

Completed Phase 3

~1120

Fludarabine phosphate

2007

Completed Phase 2

~360

Cyclophosphamide

1995

Completed Phase 3

~3770

Mesna

2003

Completed Phase 2

~1380

Tacrolimus

2011

Completed Phase 4

~4740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,478 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

367 Previous Clinical Trials

55,398 Total Patients Enrolled

Uday Popat, MDPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

357 Total Patients Enrolled

Frequently Asked Questions

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

Which individuals meet the eligibility criteria for participation in this trial?

"To be eligible for participation, individuals must exhibit splenomegaly and fall within the age bracket of 18 to 75 years. The study aims to recruit a total of 30 participants."

Answered by AI

Is the clinical trial open to individuals below the age of 45?

"Individuals aged between 18 and 75 are eligible for participation in this study. Out of the total trials, 11 focus on participants under 18 years old while 102 cater to those above the age of 65."

Answered by AI

Are new participants currently being welcomed to enroll in this trial?

"As per the details on clinicaltrials.gov, this particular research endeavor is not presently seeking individuals for participation. The project was first listed on September 30th, 2024 and underwent its latest revision on April 2nd, 2024. Although recruitment isn't ongoing for this study now, there are currently 106 other trials actively seeking participants."

Answered by AI

Has the FDA authorized the use of Ruxolitinib in combination with Allogeneic Stem Cell Transplantation?

"The safety evaluation conducted by our team at Power for the combination of Ruxolitinib and Allogeneic Stem Cell Transplantation is rated as 2 on a scale ranging from 1 to 3. This assessment aligns with the trial being in Phase 2, indicating existing evidence supporting safety but lacking data concerning efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly

2024. "High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06345495.

All > Myelofibrosis