Study Details

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Comparison of drug combinations to prevent graft-versus-host disease after stem cell transplant

The purpose of this study to see if the drug ruxolitinib with the drugs tacrolimus and methotrexate given before and following a peripheral blood stem cell transplant will prevent graft-versus-host disease (GVHD), a serious complication of a stem cell transplant, better than the drugs post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to determine if you are eligible for the study. You will also have exams and tests performed as part of the routine care for a peripheral blood cell transplant. If you are eligible, you will be randomized (assigned) to one of the treatment groups. You will receive your transplant, with some blood taken for the study prior and after your transplant. After your transplant, you will receive one of the two possible drug combinations to prevent graft-versus-host disease. For both drug combinations, you will provide blood samples for the study, urine tests, and complete questionnaires.

Incentives

You will receive a $20 Visa gift card for each survey you complete (a total of $140 if all surveys are completed)

In-person visits:
27

Phone or online visits:
0, some surveys may be completed by phone, online, or on paper

Total length of participation:
2 years

Looking for Specific Volunteers

Able to participate:

Planning to undergo an allogeneic hematopoietic cell transplantation for leukemia or lymphoma
Must have a related or unrelated donor peripheral blood stem cell donor
Adequate lab values as per protocol requirements
Adequate organ function as per protocol requirements
Agree to contraception as per protocol requirements

Not eligible if:

Prior allogeneic transplant
Active CNS involvement by malignant cells
Have uncontrolled bacterial, viral, or fungal infections at time of enrollment
Arterial or venous thrombosis
Prior use of ruxolitinib

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Janell Markey
janell_markey@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Anson Snow
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia, Lymphoma)
Transplant

IRB Number

24-2867

ClinicalTrials.gov

NCT06615050