Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
Study NCT ID:
NCT02918292
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2016-09-27
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)
Status:
COMPLETED
Status Verified Date:
2022-11
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:
CHAMP
Brief Summary:
This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).
Detailed Description:
Acquired SAA is a rare bone marrow failure disorder with an estimated annual incidence of 2 cases per million and with over 600 new cases in the United States each year. A major challenge in treating acquired SAA is the management of patients who are refractory to immunosuppressant therapy (IST) or have relapsed after IST. HSCT is the only curative option for these patients but many are ineligible because they lack a suitable donor. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) seeks to increase options for these patients by using novel therapeutic strategies of GVHD prophylaxis with PTCy to expand the donor pool to include haploidentical donors. The goal of this protocol is to test whether optimized approaches using haploidentical donors will achieve acceptable outcomes in SAA patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2U10HL069294-11 | NIH | None | https://reporter.nih.gov/quic… | View |
| 5U24CA076518 | NIH | None | https://reporter.nih.gov/quic… | View |