NCT03128359 - High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

August 1, 2020

Study Completion Date

September 15, 2021

Conditions

Acute LeukemiaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Myelogenous Leukemia, BCR-ABL1 PositiveDiffuse Large B-Cell LymphomaFollicular LymphomaGraft Versus Host DiseaseHodgkin LymphomaMantle Cell LymphomaMarginal Zone LymphomaMyelodysplastic SyndromeMyeloproliferative NeoplasmRecurrent Acute Myeloid Leukemia With Myelodysplasia-Related ChangesRecurrent Plasma Cell MyelomaRefractory Plasma Cell MyelomaSecondary Myelodysplastic Syndrome

Interventions

DRUG

Busulfan

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo PBSC HCT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan Hydrochloride

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC HCT

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Tacrolimus

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

Trial Locations (1)

91010

City of Hope Medical Center, Duarte

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER