Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HaploHCT) Following Reduced Intensity Conditioning (RIC) for Selected High Risk Non-Malignant Diseases
NCT03367546 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-07-12
Summary
This is a Phase II study for the use of T-cell replete reduced intensity conditioning (RIC) haploidentical donor allogeneic hematopoietic cell transplantation (HaploHCT) for individuals with high-risk non-malignant diseases who lack a suitable HLA-matched sibling donor.
Conditions
- Sickle Cell Disease
- Thalassemia
- High Risk Hematologic Disorders
- Cerebral Adrenoleukodystrophy
- Inherited Metabolic Disorders
Interventions
- PROCEDURE
-
Blood and Marrow Transplant
Reduced intensity conditioning (RIC) with rabbit ATG, fludarabine, cyclophosphamide, thiotepa and low dose (2 Gy) total body irradiation followed by T-cell replete, unmanipulated, haploidentical related donor stem cell transplant (HaploHCT) and post-transplant cyclophosphamide (PTCy)
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Christen L Ebens, MD, MPH · University of Minnesota - Pediatrics Blood and Marrow Transplant
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-02
- Primary Completion
- 2022-12-19
- Completion
- 2022-12-19
Countries
- United States
Study Locations
More Related Trials
-
Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells
NCT01050764 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies
NCT00566696 ·Status: COMPLETED ·Phase: PHASE2
-
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen
NCT02199041 ·Status: TERMINATED ·Phase: PHASE2
-
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
NCT05088356 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Haplo-identical SCT for High Risk (HR) Hematologic Malignancies w/Post-Transplant In-Vivo T-cell Depletion
NCT02053545 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Haploidentical Stem Cell Transplantation for Patients With Hematologic Malignancies
NCT00186823 ·Status: COMPLETED ·Phase: PHASE3
-
Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
NCT00049504 ·Status: COMPLETED ·Phase: PHASE2
-
Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies
NCT00143559 ·Status: COMPLETED ·Phase: PHASE2
-
T-Cell-Depleted Allogeneic Stem Cell Transplantation After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
NCT00080925 ·Status: COMPLETED ·Phase: PHASE1
-
Bone Marrow Transplantation in Treating Patients With Leukemia
NCT00006451 ·Status: WITHDRAWN ·Phase: PHASE3
-
Allo HSCT Using RIC for Hematological Diseases
NCT02661035 ·Status: COMPLETED ·Phase: PHASE2
-
A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
NCT01384513 ·Status: COMPLETED ·Phase: PHASE2
-
Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
NCT00005641 ·Status: TERMINATED ·Phase: PHASE2
-
Stem Cell Transplant for Hemoglobinopathy
NCT00176852 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
NCT06807606 ·Status: RECRUITING ·Phase: PHASE2
-
Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS
NCT00025662 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
NCT06839456 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Allogeneic Transplantation From Related Haploidentical Donors
NCT00185692 ·Status: COMPLETED ·Phase: PHASE2
-
Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation
NCT01087294 ·Status: COMPLETED ·Phase: PHASE1
-
A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives
NCT01532635 ·Status: TERMINATED ·Phase: PHASE2
-
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
NCT03314974 ·Status: RECRUITING ·Phase: PHASE2
-
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
NCT01341301 ·Status: COMPLETED ·Phase: PHASE2
-
Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT01871441 ·Status: TERMINATED ·Phase: PHASE2
-
Allo HSCT Using RIC and PTCy for Hematological Diseases
NCT05805605 ·Status: RECRUITING ·Phase: PHASE2
-
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
NCT06412497 ·Status: RECRUITING ·Phase: PHASE2