Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299462
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-03-13
Brief Title:
PTCy and ATG for MSD and MUD Transplants
Sponsor:
Instituto Nacional de Cancer Brazil
Organization:
Instituto Nacional de Cancer Brazil
Study Overview
Official Title:
Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis With ATG Calcineurin Inhibitor-free for Matched-sibling or Matched-unrelated Transplantation
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease Since the end of the 1970s with the introduction of cyclosporine calcineurin inhibitors cyclosporine and tacrolimus have become part of almost all prophylactic regimens even though they are a group of drugs with a poor toxicity profile that requires monitoring constant serum level Since 2008 post-transplant cyclophosphamide has been introduced with great success associated with a calcineurin inhibitor and mycophenolate in the prophylaxis of graft-versus-host disease in haploidentical transplantation 50 matched
Since then in view of this enormous success efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants or with a mismatch
This is a prospective 2-arm non-randomized study Arm 1 with related donors and arm 2 with unrelated donors Patients will be allocated in these arms according to donor availability patients with a matched-sibling donor will receive a matched-sibling transplant patients with no related donors but with unrelated donors an unrelated transplant
Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study
The stem cell collection target will be 5E6 CD34kg recipient weight for peripheral source If a quantity greater than this is collected the remainder will be cryopreserved according to the institutional protocol
Graft-versus-host disease prophylaxis will be performed on D3 and D4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1 depending on ATG de-escalation for matched-sibling transplants according to prespecified criteria based on the 33 approach and on D3 and D4 with cyclophosphamide and with ATG on D-2 and D-1 for unrelated donors
Since then in view of this enormous success efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants or with a mismatch
This is a prospective 2-arm non-randomized study Arm 1 with related donors and arm 2 with unrelated donors Patients will be allocated in these arms according to donor availability patients with a matched-sibling donor will receive a matched-sibling transplant patients with no related donors but with unrelated donors an unrelated transplant
Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study
The stem cell collection target will be 5E6 CD34kg recipient weight for peripheral source If a quantity greater than this is collected the remainder will be cryopreserved according to the institutional protocol
Graft-versus-host disease prophylaxis will be performed on D3 and D4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1 depending on ATG de-escalation for matched-sibling transplants according to prespecified criteria based on the 33 approach and on D3 and D4 with cyclophosphamide and with ATG on D-2 and D-1 for unrelated donors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None