Prognostic factors affecting outcome after allogeneic transplantation for hematological malignancies from unrelated donors: results from a randomized trial.
Jürgen Finke, Claudia Schmoor, Wolfgang A Bethge...
https://pubmed.ncbi.nlm.nih.gov/22713691Actively Recruiting
Phase 2
Phase 3
Age: 1Year - 75Years
All Genders
ID03818334
Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial
Led by Hospital Israelita Albert Einstein · Updated on 2019-02-01
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of cyclophosphamide compared to antihuman T-lymphocyte immune globulin (ATG) in patients undergoing bone marrow transplants from matched unrelated donors for hematological malignancies. The study aims to measure overall survival, progression-free survival, and the incidence of both acute and chronic graft versus host disease (GvHD). This is a prospective randomized controlled trial conducted by Hospital Israelita Albert Einstein involving patients aged 1 to 75 years. Participants will be randomly assigned to one of two treatment groups. One group will receive cyclophosphamide at 50 mg/kg on days +3 and +4, followed by a calcineurin inhibitor and mycophenolate mofetil starting on day +5 until day +35. The other group will receive thymoglobulin (ATG) at a total dose of 5 mg/kg from days -4 to -1, along with a calcineurin inhibitor starting on day +5 and methotrexate on days +1, +3, +6, and +11. These treatments are studied as strategies to prevent graft versus host disease after transplantation. During the study, researchers will assess overall survival over four years as the primary outcome. Secondary outcomes include progression-free survival, acute and chronic graft versus host disease occurrences, and treatment-related mortality, all monitored over the same period. Participants will undergo regular evaluations to monitor these outcomes and ensure safety. The total duration of participant involvement may extend up to four years to capture long-term results.
CONDITIONS
Brief Title
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Who Can Participate
Age: 1Year - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women of any age
- Indication for a hematopoietic stem cell transplant without a matched sibling donor
- Have a matched unrelated donor with HLA compatibility of 10/10 or 9/10
- Diagnosis of hematological malignancy
You will not qualify if you...
- Acute leukemias not in complete response (more than 5% blasts in bone marrow)
- Chemorefractory lymphoproliferative disease
- Active uncontrolled infection
- Hematopoietic cell transplantation-comorbidity index (HCT-CI) greater than 3
- Severe organ dysfunction (heart ejection fraction less than 45%, glomerular filtration rate less than 50 mL/hour, pulmonary DLCO less than 50%)
- Previous allogeneic bone marrow transplantation
- Contraindication to cyclophosphamide or ATG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 35 days
Participants receive assigned drug regimens starting around the time of stem cell transplantation to prevent graft versus host disease.
Multiple visits during the first 5 weeks post-transplant
Follow-up
Duration - Up to 4 years
Participants are monitored for overall survival and graft versus host disease outcomes over 4 years after treatment.
Regular follow-up visits over 4 years
Trial Site Locations
Total: 1 location
1
Hospita Israelita Albert Eintein
São Paulo, São Paulo, Brazil, 05652-900
Actively Recruiting
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Research Team
A
Andreza A Feitosa Ribeiro
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation.
Andrea Bacigalupo, Teresa Lamparelli, Giovanni Barisione...
https://pubmed.ncbi.nlm.nih.gov/16635791Impact of antithymocyte globulin doses in reduced intensity conditioning before allogeneic transplantation from matched sibling donor for patients with acute myeloid leukemia: a report from the acute leukemia working party of European group of Bone Marrow Transplantation.
Raynier Devillier, Myriam Labopin, Patrice Chevallier...
https://pubmed.ncbi.nlm.nih.gov/29330391Outcomes after matched unrelated donor versus identical sibling hematopoietic cell transplantation in adults with acute myelogenous leukemia.
Wael Saber, Shaun Opie, J Douglas Rizzo...
https://pubmed.ncbi.nlm.nih.gov/22327226Post-transplantation cyclophosphamide versus conventional graft-versus-host disease prophylaxis in mismatched unrelated donor haematopoietic cell transplantation.
Rohtesh S Mehta, Rima M Saliba, Julianne Chen...
https://pubmed.ncbi.nlm.nih.gov/26947769Post-transplant high-dose cyclophosphamide after HLA-matched vs haploidentical hematopoietic cell transplantation for AML.
A Rashidi, M Slade, J F DiPersio...
https://pubmed.ncbi.nlm.nih.gov/27526282Graft-versus-Host Disease Prophylaxis in Unrelated Peripheral Blood Stem Cell Transplantation with Post-Transplantation Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil.
Ivan S Moiseev, Olga V Pirogova, Alexandr L Alyanski...
https://pubmed.ncbi.nlm.nih.gov/26970381Low immunosuppressive burden after HLA-matched related or unrelated BMT using posttransplantation cyclophosphamide.
Christopher G Kanakry, Javier Bolaños-Meade, Yvette L Kasamon...
https://pubmed.ncbi.nlm.nih.gov/28049637