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

ConditionsSplenomegaly Myelofibrosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging.

Disqualifiers

Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.

Ejection fraction <40%

Corrected DLCO < 50%

Uncontrolled and/or active systemic infection (viral, bacterial or fungal)

Trial design

Design model

Single group

Treatments tested in this trial

Ruxolitinib
Drug
Given by PO
Allogeneic Stem Cell Transplantation
Procedure/Surgery
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

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Ruxolitinib and Allogeneic Stem Cell TransplantationExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

Through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov

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