Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
NCT03818334 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-02-01
Summary
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).
Conditions
- Bone Marrow Transplant Complications
- Graft Versus Host Disease
- Infection Viral
- Engraft Failure
- Immunologic Suppression
Interventions
- DRUG
-
Cyclophosphamide 1000 mg/flask
- DRUG
-
ATG
Antihuman T-Lymphocyte Immune Globulin 25 mg/flask
Sponsors & Collaborators
-
Hospital Israelita Albert Einstein
lead OTHER
Principal Investigators
-
Andreza A Feitosa Ribeiro, PhD · Hospital Israelita Albert Einstein
-
Nelson Hamerschlak, PhD · Hospital Israelita Albert Einstein
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-06
- Primary Completion
- 2021-11-01
- Completion
- 2026-11-01
Countries
- Brazil
Study Locations
More Related Trials
-
Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
NCT02294552 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
NCT01749111 ·Status: TERMINATED ·Phase: PHASE3
-
GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide
NCT04622956 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
NCT00343785 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
PTCy and ATG for MSD and MUD Transplants
NCT06299462 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
NCT02193880 ·Status: COMPLETED ·Phase: NA
-
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
-
Open-Label Study Designed to Evaluate the Safety and Preliminary Efficacy of ApoCell for the Prevention of Acute GvHD
NCT00524784 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity
NCT03032783 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
NCT01427881 ·Status: COMPLETED ·Phase: PHASE2
-
Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors
NCT01374841 ·Status: UNKNOWN ·Phase: PHASE2
-
Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant
NCT02300571 ·Status: UNKNOWN
-
GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG
NCT05153226 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
NCT00054340 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation
NCT03602898 ·Status: WITHDRAWN ·Phase: PHASE2
-
Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer
NCT00787761 ·Status: COMPLETED ·Phase: PHASE2
-
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
NCT00611351 ·Status: COMPLETED ·Phase: PHASE2
-
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
NCT00378534 ·Status: COMPLETED ·Phase: PHASE2
-
Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
NCT00740467 ·Status: UNKNOWN ·Phase: PHASE2
-
Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
NCT01283776 ·Status: COMPLETED ·Phase: PHASE2
-
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
NCT04904588 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
NCT02248597 ·Status: COMPLETED ·Phase: PHASE2
-
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
NCT00544115 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2