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Acute Lymphoblastic Leukemia > Allogeneic Hematopoietic Stem Cell Transplantation

GVHD Prophylaxis Regimens for Blood Cancer Stem Cell Transplant

Recruiting in Palo Alto (17 mi)

Overseen ByMasumi Ueda Oshima

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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

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.

I am 18-50 years old with a blood disease, at high risk due to my medical history.

My donor is a partial match for my transplant.

My donor is a match for HLA class I and may have up to two mismatches in DRB1 or DQB1.

My donor is not a full HLA match but matches at key HLA points.

My AML is in remission with less than 5% marrow blasts.

I have CML and either TKIs didn't work for me or I couldn't tolerate them.

My genetic match for the transplant is nearly perfect, with only one minor difference.

My donor and I do not have a two-allele mismatch.

I am between 18 and 50 years old with chronic lymphocytic leukemia.

My leukemia has less than 5% marrow blasts before transplant.

My stem cell donor will use G-CSF for stem cell collection.

My BPDCN is currently in complete remission.

My donor and I are a close match for bone marrow transplant.

My Hodgkin lymphoma did not respond to the first treatment I received.

I have an aggressive type of non-Hodgkin lymphoma and am not a candidate for certain stem cell transplants.

I am over 50 and have a blood cancer treatable by a stem cell transplant.

I am between 18-50 years old and need a transplant for my blood disease but refuse high-dose treatment.

My leukemia has less than 5% marrow blasts before transplant.

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.

I have an infection that hasn't improved with treatment.

I have CMML and haven't had induction chemotherapy.

I have MDS-EB or AML and haven't had strong chemotherapy or a specific treatment regimen.

My blood test shows cancer cells for AML, ALL, or CML.

I am not willing to use birth control during and for a year after treatment.

I have a fungal infection that didn't improve after 1 month of specific treatment.

My lung function is severely impaired or I need extra oxygen.

My liver functions normally without serious diseases like cirrhosis or severe hepatitis.

My donor's HLA type does not match mine exactly at a specific genetic spot.

My brain or spinal cord cancer hasn't responded to chemotherapy in the spine.

I am not pregnant or breastfeeding.

My health severely limits my ability to care for myself.

I am currently receiving hemodialysis.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Arm II (cyclosporine, sirolimus, cyclophosphamide)Experimental Treatment4 Interventions

Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4.

Group II: Arm I (mycophenolate mofetil, cyclosporine, sirolimus)Experimental Treatment4 Interventions

Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365.

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

🇪🇺 Approved in European Union as Allogeneic Hematopoietic Stem Cell Transplantation for: