BMT CTN 2203 (Allogeneic Stem Cell Transplantation)

Purpose of this Study

We are doing this study to find out if an experimental drug called ruxolitinib is a safe and effection option for preventing graft-versus-host disease when it is given in combination with the drugs tacrolimus and methotrexate before and after a peripheral blood stem cell transplant. We want to know if this study drug combination works better than the standard post-transplant treatment of cyclophosphamide, tacrolimus, and mycophenolate mofetil.

Who Can Participate?

Eligibility

Adults ages 18+ who will receive an allogeneic blood-forming stem cell transplant for one of the follow reasons:
  • Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed.
  • Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with < 5% versus 5-10% blasts in this disease). Therapy related myeloid neoplasms are allowed.
  • Lymphoma [follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma]
For more information about this study, contact the study team at jennifer.tichon@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to either take part in Group A or Group B. If you are assigned to Group A, you will:
  • Take ruxolitinib twice a day as a pill by mouth beginning the day before your transplant. The dose given will be determined by the study's run-in phase. You will continue taking this drug for 12 months after your transplant.
  • Take tacrolimus as a pill by mouth each day or through your vein (IV) beginning 3 days before your transplant.
  • Take methotrexate through your vein on 3 different days (Days 1, 3, and 6) after your transplant.
If you are assigned to Group B, you will:
  • Take tacrolimus as a pill by mouth each day or through your vein (IV) beginning 3 days before your transplant.
  • Take mycophenolate mofetil through your vein or as a pill by mouth 3 times a day, beginning on Day 5 after your transplant. You will take this drug for 30 days.
  • Take cyclophosphamide through your vein on Days 3 and 4 after your transplant.
Your participation in the study will last about 2 years.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in
Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Principal Investigator

Sanghee
Hong

Protocol Number

PRO00117058

NCT ID

NCT06615050

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov