Health Trials

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

ConditionsAML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)Acute Leukemia (Category)MDS (Myelodysplastic Syndrome)CML (Chronic Myelogenous Leukemia)CLL (Chronic Lymphocytic Leukemia)Prolymphocyctic LeukemiaChronic Myelomonocytic Leukemia (CMML)Myeloproliferative Neoplasm (MPN)LymphomaMyelofibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-66
SponsorCenter for International Blood and Marrow Transplant Research

About this trial

The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.

Participants will:

* Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples.

Eligibility criteria

Qualifiers

Age 18 to < 66 years (chemotherapy-based conditioning) or < 61 years (TBI-based conditioning) at the time of signing informed consent

Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements

Stated willingness to comply with all study procedures and availability for the duration of the study

Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)

Disqualifiers

Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available

Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing

Subjects with a prior allogeneic transplant

Subjects with an autologous transplant within the past 3 months

Trial design

Treatments tested in this trial

  • Conditioning Regimen A
  • Conditioning Regimen B
  • Conditioning Regimen C
  • Conditioning Regimen D
  • Conditioning Regimen E
  • Hematopoietic Cell Transplantation
  • PTCy (50 mg/kg D3, D4)
  • PTCy (25 mg/kg D3, D4)
  • Post-transplant Tacrolimus
  • Post-transplant Mycophenolate mofetil
  • Post-transplant Abatacept
  • Post-transplant Ruxolitinib
  • Supportive Care: Growth Factors
  • Supportive Care: Blood Products
  • Supportive Care: Infection Prophylaxis
  • Supportive Care: Intravenous immune globulin (IVIG)
  • Supportive Care: Seizure prophylaxis
  • Supportive Care: Monitoring and management of CRS
  • Supportive Care: Prophylaxis against infections
  • Supportive Care: Prophylaxis against infections
  • Supportive Care: Lipid elevations
  • Study treatment compliance
  • Prohibited Concomitant Therapy
  • Permitted Concomitant Therapy
  • Prohibited Concomitant Therapy
  • Permitted Concomitant Therapy
  • Prohibited Concomitant Therapy
  • Permitted Concomitant Therapy

Treatment groups

358 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Center for International Blood and Marrow Transplant Research

Lead sponsor

National Marrow Donor Program

Collaborator

Incyte Corporation

Collaborator

Source ClinicalTrials.gov