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

Study Purpose

To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants 18 years to less than or equal to 75 years. 2. Able to provide written consent. 3. Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib) 4. Enlarged spleen by palpation or imaging. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging. 5. Has a fully matched (8/8:HLA A, B, C, DRB1) related or matched unrelated donor. 6. Adequate renal function, including: a. Serum creatinine /= 40 ml/min/1.73 m2. 7. Adequate liver function, including: 1. ALT/AST Exclusion Criteria: 1. Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females. 2. Ejection fraction <40% 3. Corrected DLCO < 50% 4. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: 1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal) 2. Prior hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same. 3. Thrombosis including MI, Stroke, PE, DVT in the past 6 months. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06345495
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Uday Popat, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Splenomegaly, Myelofibrosis
Study Website: View Trial Website
Additional Details

Primary Objective. 1) Compare the proportion of patients alive, disease free, engrafted, and without poor graft function at 100 days post-transplant with the historical rate of 45%. Secondary Objectives: 1. Overall survival. 2. Progression-free survival. 3. Graft vs.#46;host disease relapse free survival. 4. Relapse rate. 5. Non-relapse Mortality. 6. Time to Neutrophil and platelet engraftment. 7. Time to red cell transfusion independence. 8. Graft failure. 9. Acute and chronic GVHD. 10. Grade 3 -5 Toxicity. 11. Incidence of poor graft function5. 12. Need for growth factors (myeloid or thrombopoietic) at 100 days. 13. Spleen response around day -7, -1, 30, and 100 days. 14. Need for transfusions at 100 days. 15. Time to discontinuation of immunosuppressives. Exploratory Objectives: 1. Immune reconstitution. 2. Cytokine profile

Arms & Interventions

Arms

Experimental: Ruxolitinib and Allogeneic Stem Cell Transplantation

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.

Interventions

Drug: - Ruxolitinib

Given by PO

Procedure: - Allogeneic Stem Cell Transplantation

Given by Transplant

Drug: - Levetiracetam

Given by PO

Drug: - Eltrombopag

Given by PO

Drug: - Busulfan

Given by IV

Drug: - Romiplostim

Given by IV

Drug: - Fludarabine phosphate

Given by IV

Drug: - Cyclophosphamide

Given by IV

Drug: - Mesna

Given by IV

Drug: - Tacrolimus

Given by IV or PO

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Address

MD Anderson Cancer Center

Houston, Texas, 77030

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