Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01410344
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2011-08-03
Brief Title:
Allogeneic Transplant in HIV Patients BMT CTN 0903
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals BMT CTN 0903
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection In particular the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population Correlative assays will focus upon the incidence of infectious complications in this patient population the evolution of HIV infection and immunological reconstitution Where feasible and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5
Detailed Description:
The study is designed to evaluate the feasibility and safety of reduced-intensity and fully-ablative allogeneic hematopoietic cell transplantation HCT for patients with hematological malignancies or myelodysplastic syndromes MDS who have HIV infection The goal of the study is to assess the 100 day Non-relapse Mortality as well as immunological reconstitution in this patient population Where feasible an attempt will be made to identify human leukocyte antigen HLA-compatible hematopoietic stem cell donors who are homozygotes for the delta32 mutation of the chemokine receptor 5 CCR5delta32 Patients will undergo a treatment plan review prior to registration on the trial All patients will undergo allogeneic HCT from a matched sibling or unrelated donor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL069294 | NIH | None | None |
| BMT CTN 0903 | OTHER | None | None |
| 5U24CA076518 | NIH | Blood and Marrow Transplant Clinical Trials Network | httpsreporternihgovquickSearch5U24CA076518 |