Instituto Nacional de Cancer
Rio de Janeiro, 20230-130, Brazil
Location status: Recruiting
Location contact
Leonardo J Arcuri, MD
CONTACT
Simone Lermontov
CONTACT
NCT Number: NCT06299462
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 CD34/kg 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 D+3 and D+4 with cyclophosphamide and with ATG on D-3 and D-2 for matched-sibling or unrelated donors transplants.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Rio de Janeiro, 20230-130, Brazil
Location status: Recruiting
Leonardo J Arcuri, MD
CONTACT
Simone Lermontov
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ATG 2.5 mg/kg on days -3 and -2
Cyclophosphamide 50 mg/kg on days +3 and +4
ATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3
Time frame: 6 months
Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria
Time frame: 6 months
Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria
Time frame: 6 months
Cumulative incidence of steroid-refractory graft-versus-host disease
Time frame: 3 years
Cumulative incidence of chronic graft-versus-host disease
Time frame: 3 years
Cumulative incidence of steroid-requiring chronic graft versus host disease
Time frame: 3 years
Cumulative incidence of death not caused by primary malignant disease or following relapse
Time frame: 3 years
Cumulative incidence of relapse of primary malignant disease
Time frame: 3 years
Death by any cause
Time frame: 3 years
Composite outcome of death or primary disease relapse
Time frame: 3 year
Incidence of cytomegalovirus reactivation
Time frame: 3 years
Incidence of posttransplant lymphoproliferative disorder
Time frame: 3 years
Cumulative incidence of cytomegalovirus disease
Time frame: 2 years
Measurement quality of life
Contact information is provided by the study sponsor or research team.
Instituto Nacional de Cancer, Brazil
Other Gov
Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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