Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

Leonardo Javier Arcuri30 enrolled

Overview

This is a prospective observational cohort study of haploidentical transplantation with post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia (ALL).

Hematopoietic stem cell transplantation (HSCT) is the most effective treatment for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), with the lowest rates of relapse. Fertility rate in Brazil is falling, and only 25% of people born today will have a matched sibling donor. On the other hand, currently donor non-related to about 50% of patients enrolled in Brazilian Receptor Registry (REREME). Consequently, at least 35% of patients won't have a matched donor. The haploidentical transplantation is defined as a partially matched hematopoietic cell transplantation, using a partially matched family donor (parent, sibling or child). Haploidentical transplantation activity is growing worldwide, with results comparable matched unrelated donors. The objective of this study is to test the feasibility of haploidentical transplantation with post transplant cyclophosphamide for acute leukemias in a Brazil.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Haploidentical Stem Cell TransplantationPROCEDURE

Haploidentical Stem Cell Transplantation from a related donor (partially matched sibling, father, mother, son or daughter).

Eligibility

Sex: ALLMin age: 1 YearMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute lymphoblastic leukemia or acute myeloid leukemia Exclusion Criteria: * Severe comorbidities * Second transplant

Locations (1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Outcomes

Primary Outcomes

Overall Survival

1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.

Time frame: 1 year

Secondary Outcomes

Cumulative incidence of leukemia relapse

Relapse will be defined by reappearance of Leukemic Cells in bone marrow (\>5%) or peripheral blood (\>1%). Risk factors for leukemia relapse will be estimated by extended Cox Model for competing risks (Fine \& Gray model). Competing event will be defined as death in remission.

Time frame: 5 years

Transplant Related Mortality

Transplant-related mortality (TRM) will be defined as death in remission. Risk factors for TRM will be estimated by extended Cox Model for competing risks (Fine \& Gray model). Competing event will be defined as leukemia relapse.

Time frame: 6 months

Cumulative Incidence of acute Graft Versus Host Disease

Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria. Risk factor for acute graft versus host disease will be estimated by extended Cox Model for competing risks (Fine \& Gray model). Cumulative incidence curves will be estimated by Gray methodology.

Time frame: 5 years

Cumulative Incidence of chronic Graft Versus Host Disease

Chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus). Risk factor for chronic graft versus host disease will be estimated by extended Cox Model for competing risks (Fine \& Gray model). Cumulative incidence curves will be estimated by Gray methodology.

Time frame: 5 years

Cumulative Incidence of Infectious Complications

Cumulative incidence of viral, fungal and bacterial infections. Subgroups will be compared by Cox Model for competing risks (Fine \& Gray model). Cytomegalovirus reactivation will be analyzed by multiple events Cox Model.

Central Contacts

Leonado J Arcuri, MD

CONTACT

+55(21)32071304 leonardojavier@gmail.com

Data from ClinicalTrials.gov

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