150 Participants Needed

GVHD Prophylaxis Regimens for Blood Cancer Stem Cell Transplant

MU
Overseen ByMasumi Ueda Oshima
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Fred Hutchinson Cancer Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II trial includes a blood stem cell transplant from an unrelated donor to treat blood cancer. The treatment also includes chemotherapy drugs, but in lower doses than conventional (standard) stem cell transplants. The researchers will compare two different drug combinations used to reduce the risk of a common but serious complication called "graft versus host disease" (GVHD) following the transplant. Two drugs, cyclosporine (CSP) and sirolimus (SIR), will be combined with either mycophenolate mofetil (MMF) or post-transplant cyclophosphamide (PTCy). This part of the transplant procedure is the main research focus of the study.

Who Is on the Research Team?

MU

Masumi Ueda Oshima

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Adults aged 18-50 with certain high-risk blood cancers treatable by stem cell transplant from an unrelated donor, but who can't handle high-dose transplants due to medical conditions or prior therapy. Specific criteria include having less than 5% marrow blasts for some leukemias and being in remission for others. Must not be pregnant, breastfeeding, have severe organ dysfunction or active infections unresponsive to treatment.

Inclusion Criteria

My condition is approved by the trial's lead researcher.
I have Waldenstrom's macroglobulinemia and two treatments have not worked for me.
My donor and I mismatch for two HLA class I alleles but match for HLA-DRB1 and HLA-DQ.
See 25 more

Exclusion Criteria

My lymphoma is fast-growing and not low grade.
My blood has at least 5% leukemia cells.
I have high blood pressure that isn't well-controlled despite taking several medications.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning and Transplantation

Patients undergo allogeneic hematopoietic stem cell transplant (HCT) at day 0 with conditioning regimen

1 week
Inpatient stay for transplantation

GVHD Prophylaxis Treatment

Patients receive GVHD prophylaxis with either mycophenolate mofetil, cyclosporine, and sirolimus or cyclosporine, sirolimus, and cyclophosphamide

Up to 52 weeks
Regular follow-up visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Follow-up at 6 months and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Cyclophosphamide
  • Cyclosporine
  • Mycophenolate Mofetil
  • Sirolimus
Trial Overview This phase II trial tests a lower dose of chemotherapy combined with a blood stem cell transplant from an unrelated donor to treat various blood cancers. It compares two drug combinations (CSP+SIR+MMF vs CSP+SIR+PTCy) aiming to reduce graft versus host disease risk after the transplant.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (cyclosporine, sirolimus, cyclophosphamide)Experimental Treatment4 Interventions
Group II: Arm I (mycophenolate mofetil, cyclosporine, sirolimus)Experimental Treatment4 Interventions

Allogeneic Hematopoietic Stem Cell Transplantation is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Allogeneic Hematopoietic Stem Cell Transplantation for:
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Approved in United States as Allogeneic Hematopoietic Stem Cell Transplantation for:
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Approved in Canada as Allogeneic Hematopoietic Stem Cell Transplantation for:
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Approved in Japan as Allogeneic Hematopoietic Stem Cell Transplantation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials
444
Recruited
148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+
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