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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03818334

Enrollment

Registered

2019-01-28

Start date

2018-11-06

Completion date

2026-11-01

Last updated

2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Bone Marrow Transplantation, Hematological Malignancies, Post-Cy

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).

Interventions

DRUGCyclophosphamide

Cyclophosphamide 1000 mg/flask

DRUGATG

Antihuman T-Lymphocyte Immune Globulin 25 mg/flask

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	4 years	Time to last follow-up or death

Secondary

Measure	Time frame	Description
Treatment Related Mortality	4 years	Time until death related to HSCT complications
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

Other

Measure	Time frame	Description
Days hospitalized	First 100 days after graft infusion	Days admitted to the hospital
Graft Failure Incidence	2 years	ANC \< 500/microL after 42 days after graft infusion
Time Until Neutrophil Engraftment	2 years	Time to ANC \> 500/microL for three consecutive days
Time Until Platelet Engraftment	2 years	Time to platelet count \> 50,000/microL, without transfusion in the last 7 days
Immunological Reconstitution	Days +60, +100 and +180	Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)

Countries

Brazil

Contacts

Primary ContactAndreza A Feitosa Ribeiro

andreza.ribeiro@einstein.br+5511992512523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026