Chemo/Radiation Therapy + Stem Cell Transplant for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMonzr M. Al Malki

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This pilot phase I trial studies the side effects of combination chemotherapy, total body irradiation, and donor blood stem cell transplant in treating patients with secondary myelofibrosis. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving combination chemotherapy and total body irradiation before a donor blood stem cell transplant helps to stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Eligibility Criteria

This trial is for patients with secondary myelofibrosis who are fit (Karnofsky performance >=70%), have adequate organ function, and no severe pulmonary or liver conditions. Donors must be a genetic half-match without certain infections or health risks, and not pregnant if female of childbearing potential.

Inclusion Criteria

DONOR: Is approved and completed evaluation prior to recipient initiation of the preparative regimen per institutional guidelines

Left ventricular ejection fraction (LVEF) >= 50%

My donor is a relative who is not my mother and matches half of my HLA markers.

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Exclusion Criteria

I have severe liver issues with symptoms like bleeding, fluid buildup, or confusion.

I have had a transplant involving solid organ, stem cell, bone marrow, or blood.

I have liver cirrhosis.

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Treatment Details

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation (Hematopoietic Stem Cell Transplantation)
Cyclophosphamide (Alkylating agents)
Fludarabine (Antimetabolites)
Melphalan (Alkylating agents)
Mycophenolate Mofetil (Other)
Tacrolimus (Immunosuppressant)
Total-Body Irradiation (Radiation Therapy)

Trial OverviewThe trial tests a treatment combining chemotherapy drugs (Melphalan, Mycophenolate Mofetil, Tacrolimus, Cyclophosphamide, Fludarabine), total body irradiation, and donor blood stem cell transplant to see how well it treats secondary myelofibrosis.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy, TBI, HCT)Experimental Treatment9 Interventions

Patients receive melphalan IV over 30 minutes on day -5, fludarabine IV over 30-60 minutes on days -5 to -2. Patients undergo TBI on day -1 and HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3 and 4. Starting on day 5, patients receive tacrolimus IV then PO for 6 months followed by a taper, mycophenolate mofetil PO TID until day 35, and G-CSF IV daily until absolute neutrophil count \> 1,500/mm\^3 for 3 consecutive days. Treatment continues in the absence of disease progression or unexpected toxicity.

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: