Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Study Overview
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Brief Summary
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This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).

Official Title
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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

Conditions
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Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral, Engraft Failure, Immunologic Suppression

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: ATG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women of Any Age Indication for an HSCT without matched sibling donor Have a matched unrelated donor (HLA 10 x 10 or 9 x 10) Hematological malignancy Exclusion Criteria: Acute leukemias not in complete response (that is > 5% blast in the bone marrow) Chemorefractory lymphoproliferative disease Active uncontrolled infection HCT-CI > 3 Severe organic disfunction (heart ejection fraction < 45%, glomerular filtration rate < 50 mL.hour, pulmonary DLCO < 50%) Previous allogeneic bone marrow transplantation Contraindication to cyclophosphamide or ATG

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post Cyclophosphamide<br>Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35 | Drug: Cyclophosphamide<br>* Cyclophosphamide 1000 mg/flask<br>* Other names: Cytoxan;|
| Active Comparator: Thymoglobulin (ATG)<br>Thymoglobulin (ATG) total dose 5 mg/Kg from day -4 until day -1 AND Calcineurin Inhibitor from day +5 AND Methotrexate on days +1, +3, +6 and +11 | Drug: ATG<br>* Antihuman T-Lymphocyte Immune Globulin 25 mg/flask<br>* Other names: Thymoglobulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time to last follow-up or death | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time until last follow-up, death or disease relapse | 4 years | 
| Acute Graft Versus Host Disease | Time until acute GvHD development | 4 years | 
| Chronic Graft Versus Host Disease | Time until chronic GvHD development | 4 years | 
| Treatment Related Mortality | Time until death related to HSCT complications | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Transplantation, Hematological Malignancies, Post-Cy