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
NCT03128359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2024-01-09
Summary
This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Conditions
- Acute Leukemia
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Graft Versus Host Disease
- Hodgkin Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
- Secondary Myelodysplastic Syndrome
Interventions
- DRUG
-
Busulfan
Given IV
- DRUG
-
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
-
Given IV
- RADIATION
-
Total-Body Irradiation
Undergo TBI
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Monzr Al Malki, MD · City of Hope Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-30
- Primary Completion
- 2020-08-01
- Completion
- 2021-09-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
NCT06996119 ·Status: RECRUITING ·Phase: PHASE1
-
A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
NCT06859424 ·Status: RECRUITING ·Phase: PHASE2
-
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
NCT00003196 ·Status: COMPLETED ·Phase: NA
-
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
NCT00544115 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
NCT03192397 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
NCT00611351 ·Status: COMPLETED ·Phase: PHASE2
-
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
NCT00691015 ·Status: COMPLETED ·Phase: PHASE2
-
Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
NCT01231412 ·Status: COMPLETED ·Phase: PHASE3
-
Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases
NCT00317785 ·Status: COMPLETED ·Phase: PHASE2
-
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT01028716 ·Status: TERMINATED ·Phase: PHASE2
-
Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide
NCT01342289 ·Status: COMPLETED ·Phase: PHASE1
-
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
NCT05436418 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
NCT00589563 ·Status: COMPLETED ·Phase: PHASE2
-
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
NCT02248597 ·Status: COMPLETED ·Phase: PHASE2
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
NCT03970096 ·Status: RECRUITING ·Phase: PHASE2
-
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
NCT00134004 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
NCT03246906 ·Status: TERMINATED ·Phase: PHASE2
-
Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant
NCT01251575 ·Status: COMPLETED ·Phase: PHASE2
-
A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
NCT01349101 ·Status: COMPLETED ·Phase: PHASE2
-
Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants
NCT05364762 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies
NCT01789255 ·Status: COMPLETED ·Phase: PHASE2
-
Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT02566304 ·Status: COMPLETED ·Phase: PHASE2
-
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
NCT00006042 ·Status: COMPLETED ·Phase: PHASE1
-
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
NCT00789776 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
NCT00096096 ·Status: COMPLETED ·Phase: PHASE2