Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Leukemia

Graft vs Host Disease

Preleukemia

Myelodysplastic Syndromes

Syndrome

Bronchiolitis

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Pneumonia

Organizing Pneumonia

Bronchitis

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases

Lung Diseases, Obstructive

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Acute Graft Versus Host Disease

Bronchiolitis Obliterans Organizing Pneumonia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Thymoglobulin

Antilymphocyte Serum

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Anti-Thymocyte globulin (rabbit)

Sarah Garisto, BSc

Louise Christophersen

Molly Forbes

Nada Hamad, MBBS MSc

Kristjan Paulson, MD

Mahmoud Elsawy, MD

Irwin Walker, MBBS

Uday Deotare, MD

Genevieve Gallagher, MD

Mohamed Elemary, MD

Irwin R Walker, MBBS

A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.

Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.

ATG Plus PTCy vs ATG for CGVHD Prophylaxis

A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD)

Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)

Chronic graft versus host disease free- and relapse-free survival (CRFS)

Graft versus host disease-, and relapse-, free survival (GRFS)

Survival (dead/alive) at 100 days for each patient

The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection

The sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget.

Cell Therapy Transplant Canada

Sanofi

Ozmosis Research Inc.

McMaster University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ATG Plus PTCy vs ATG for CGVHD Prophylaxis	NCT04202835	Acute Leukemia Myelodysplasia Chronic Graft-v...	Cyclophosphamid... Anti-Thymocyte ...	16 Years - 70 Years	McMaster University
ATG Plus PTCy vs ATG for CGVHD Prophylaxis	NCT04202835	Acute Leukemia Myelodysplasia Chronic Graft-v...	Cyclophosphamid... Anti-Thymocyte ...	16 Years - 70 Years	McMaster University

Spots Global Cancer Trial Database for post transplant cyclophosphamide