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Trial Title:
PTCy and ATG for MSD and MUD Transplants
NCT ID:
NCT06299462
Condition:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Cyclophosphamide
Conditions: Keywords:
posttransplant cyclophosphamide
ATG
calcineurin-free GVHD prophylaxis
graft-versus-host disease
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while
patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ATG 5.0
Description:
ATG 2.5 mg/kg on days -2 and -1
Arm group label:
Matched unrelated donor transplants
Intervention type:
Drug
Intervention name:
Cyclophosphamide injection
Description:
Cyclophosphamide 50 mg/kg on days +3 and +4
Arm group label:
Matched unrelated donor transplants
Arm group label:
Matched-sibling donor transplants
Intervention type:
Drug
Intervention name:
ATG 2.5±1.5
Description:
ATG 2.5 mg/kg on day -1 ± 1.5 mg/kg on day -2
Arm group label:
Matched-sibling donor transplants
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 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-1 or on D-2 and D-1, depending on ATG de-escalation,
for matched-sibling transplants, according to prespecified criteria based on the 3+3
approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for
unrelated donors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia
with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial
remission after salvage therapy
- Who will receive a related or unrelated, HLA-compatible transplant;
- Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu
conditioning;
- Peripheral blood source;
- Age between 18 and 60 years.
Exclusion Criteria:
- Renal dysfunction (Cr > 1.5 mg/dL)
- Hepatic dysfunction (transaminases x2 the normal value)
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Nacional de Cancer
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Leonardo J Arcuri, MD
Phone:
+55(21)3207-1304
Email:
leonardojavier@gmail.com
Contact backup:
Last name:
Simone Lermontov
Phone:
+55(21)3207-1261
Email:
simonelermontov@globo.com
Start date:
June 20, 2024
Completion date:
June 1, 2031
Lead sponsor:
Agency:
Instituto Nacional de Cancer, Brazil
Agency class:
Other
Source:
Instituto Nacional de Cancer, Brazil
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299462