Myeloproliferative Neoplasms Clinical Trial

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

Summary

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

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Full Description

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:

Overall survival
Progression-free survival
Graft vs host disease relapse free survival
Relapse rate
Non-relapse Mortality
Time to Neutrophil and platelet engraftment
Time to red cell transfusion independence
Graft failure
Acute and chronic GVHD
Grade 3 -5 Toxicity
Incidence of poor graft function5
Need for growth factors (myeloid or thrombopoietic) at 100 days
Spleen response around day -7, -1, 30, and 100 days
Need for transfusions at 100 days
Time to discontinuation of immunosuppressives

Exploratory Objectives:

Immune reconstitution
Cytokine profile

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants 18 years to less than or equal to 75 years.
Able to provide written consent.
Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)
Enlarged spleen by palpation or imaging
Has a fully matched (8/8:HLA A, B, C, DRB1) related or matched unrelated donor
Female participants of childbearing potential must have negative results for pregnancy test.

Exclusion Criteria:

Ejection fraction <40%
Creatinine clearance < 40ml/min measured or calculated by Cockroft Gault formula
Corrected DLCO < 50%

Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
Prior hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same.
Thrombosis including MI, Stroke, PE, DVT in the past 6 months Note: participants 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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT06345495

Recruitment Status:

Not yet recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT06345495

Recruitment Status:

Not yet recruiting

Sponsor:


M.D. Anderson Cancer Center

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