Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation for the Treatment of Blood Cancer in Patients Undergoing Donor Stem Cell Transplant

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Hodgkin Lymphoma Leukemia Lymphoma Myelodysplastic Syndromes (MDS) Non-Hodgkin Lymphoma	NCT ID:	NCT04191187
Trial Phases:	Phase II	Protocol IDs:	MCC-20131 (primary) NCI-2019-08483
Eligibility:	0 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Moffitt Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04191187

Summary

This phase II trial studies how well reduced-intensity fludarabine, melphalan, and total body irradiation work in treating patients with blood cancer who are undergoing donor stem cell transplant. Drugs used in chemotherapy, such as fludarabine and melphalan, 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 radiation therapy after chemotherapy may kill the remaining cancer cells.

Objectives

PRIMARY OBJECTIVE:
I. To estimate probability of the 18 month disease free survival (DFS) after a human leukocyte antigen (HLA)-haploidentical related hematopoietic cell transplant (Haplo-HCT) using a reduced intensity fludarabine/melphalan/total body irradiation (TBI) conditioning in older patients in patients with a myeloid hematologic malignancy.

SECONDARY OBJECTIVES:
I. Incidence of day 90 grade II-IV and grade III-IV acute graft versus host-disease (GVHD).
II. Probability of 6 month and 18 month treatment-related mortality (TRM).
III. Probability of 18 month relapse incidence.
IV. Probability of 18 month overall survival (OS).

TERTIARY/EXPLORATORY OBJECTIVES:
I. Incidence of neutrophil recovery by day +30.
II. Incidence of platelet recovery by day +60.
III. Donor cell engraftment (chimerism) at day +30, +60, +90, +180 and +365.
IV. Incidence of 18 month chronic GVHD.
V. Probability of 18 month year GVHD and relapse-free survival (GRFS).
VI. Incidence of 100 day, 1 year, and 18 month serious fungal and viral infection.

PHARMACOLOGIC OBJECTIVES:
I. Evaluate pharmacokinetics of mycophenolate mofetil (MMF) measured on day 6 after transplant.
II. Evaluate single nucleotide polymorphisms (SNPs) in p450, aldehyde dehydrogenase, and glutathione S-transferase that influence cyclophosphamide metabolism.

OUTLINE:
Patients receive fludarabine intravenously (IV) over 30-60 minutes on days -6 to -2 and melphalan IV over 45 minutes on day -6. Patients undergo total body irradiation (TBI) on day -1 and Haplo-HCT on day 0. Patients receive cyclophosphamide IV over 1 hour on days 3-4. Beginning on day 5, patients receive sirolimus PO once daily (QD) for up to 180 days in the absence of graft versus host disease (GHVD), mycophenolate mofetil PO three time daily (TID) with last dose on day 35, and granulocyte colony-stimulating factor (G-CSF) IV or subcutaneously (SC) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1.5 years.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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