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

Phase 2

Recruiting

• Conditions: Graft Versus Host Disease; Engraft Failure; Immunologic Suppression; Bone Marrow Transplant Complications; Infection Viral
• Interventions: Drug: Cyclophosphamide; Drug: ATG

• Registration Number: NCT03818334
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-06
• Status Verified: 2019-01
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01
• Primary Completion: 2021-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post Cyclophosphamide	Cyclophosphamide	Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35
Thymoglobulin (ATG)	ATG	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

Primary Outcome Measures

Name	Time	Method
Overall Survival	4 years	Time to last follow-up or death

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospita Israelita Albert Eintein; 🇧🇷 São Paulo, SP, Brazil