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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06345495
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis
  • Splenomegaly

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Given by PO
  • Allogeneic Stem Cell Transplantation — PROCEDURE
    Given by Transplant
  • Levetiracetam — DRUG
    Given by PO
  • Eltrombopag — DRUG
    Given by PO
  • Busulfan — DRUG
    Given by IV
  • Romiplostim — DRUG
    Given by IV
  • Fludarabine phosphate — DRUG
    Given by IV
  • Cyclophosphamide — DRUG
    Given by IV
  • Mesna — DRUG
    Given by IV
  • Tacrolimus — DRUG
    Given by IV or PO

Study Details

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

Key Dates

Start date
Oct 1, 2024
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Uday Popat, MD
[email protected]
713-563-0812
Uday Popat, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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