Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

Leukemia, Myeloid, Acute Clinical Trial

Official title:

Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02759822
• Other study ID #: CEMO/INCA-Haplo-01
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2016
• Last updated: April 29, 2016
• Start date: April 2016

Study information

• Verified date: April 2016
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Leonado J Arcuri, MD
• Phone: +55(21)32071304
• Email: leonardojavier[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 60 Years

Eligibility

Inclusion Criteria:

• Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria:

• Severe comorbidities

• Second transplant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Cancer	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Leonardo Javier Arcuri

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.	1 year	No
Secondary	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.	5 years	No
Secondary	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.	6 months	No
Secondary	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.	5 years	No
Secondary	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.	5 years	No
Secondary	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.	1 year	No