A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

ConditionAML

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age65-75

SponsorM.D. Anderson Cancer Center

About this trial

The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 and < 75 years are eligible if they have one of the following diseases.

Acute Myeloid Leukemia

Myelodysplastic syndrome

Chronic myelomonocytic leukemia

Disqualifiers

Subject is known to be positive for HIV.

Subject has acute promyelocytic leukemia.

Subject has known active CNS involvement with AML.

Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of >5

Trial design

Design model

Single group

Treatments tested in this trial

Mycophenolate Mofetil
Drug
15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
Ruxolitinib
Drug
5 mg PO every 12 hours

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: 01A:Treatment With Post-Transplant Cyclophosphamide (PTCy), Sirolimus and MMFExperimental treatment 1 intervention

Group B: 01B:Treatment With Post-Transplant Cyclophosphamide (PTCy),Sirolimus and RuxolitinibExperimental treatment 1 intervention

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

Source ClinicalTrials.gov

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