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

Hospital Israelita Albert Einstein

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Cyclophosphamide; Drug: ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT03818334

SGPP 3549-18

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Post Cyclophosphamide

Experimental group

Description:

Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35

Treatment:

Drug: Cyclophosphamide

Thymoglobulin (ATG)

Active Comparator group

Description:

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

Treatment:

Drug: ATG