Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

• Conditions: Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Interventions: Procedure: Haploidentical Stem Cell Transplantation

• Registration Number: NCT02759822
• Lead Sponsor: Leonardo Javier Arcuri

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-29
• Last Update Submitted: 2016-04-29
• Study First Posted: 2016-05-03
• Last Update Posted: 2016-05-03
• Primary Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria

• Severe comorbidities
• Second transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B: Acute Myeloid Leukemia	Haploidentical Stem Cell Transplantation	Haploidentical Stem Cell Transplantation with Post Transplant Cyclophosphamide (PTCy) Preferred Conditioning: Mel100-140 + Flu160 + TBI200 Alternative conditionings: 1. Bu9,6 + Flu150 + TBI200 2. Cyclophosphamide 29 mg/kg + Flu150 + TBI200 Graft versus host disease Prophylaxis: PTCy + FK or CSA + MMF
Group A: Acute Lymphoblastic Leukemia	Haploidentical Stem Cell Transplantation	Haploidentical Stem Cell Transplantation with Post Transplant Cyclophosphamide (PTCy) Preferred conditioning: * Total Body Irradiation 1200 cGy (TBI1200) + Fludarabine 120 mg/m2 (Flu120) Alternative conditionings: 1. Melphalan 100-140 mg/m2 (Mel100-140) + Fludarabine 160 mg/m2 (Flu160) + Total Body Irradiation 200 cGy (TBI200) 2. Busulfan 9.6 mg/kg (Bu9.6) + Fludarabine 150 mg/m2 (Flu150) + TBI200 Graft versus host disease Prophylaxis: Post-Transplant Cyclophosphamide (PTCy) + Tacrolimus (FK) or Cyclosporin (CSA) + Mycophenolate Mofetil (MMF)

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 year	1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of leukemia relapse	5 years	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.
Transplant Related Mortality	6 months	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.
Cumulative Incidence of acute Graft Versus Host Disease	5 years	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.
Cumulative Incidence of chronic Graft Versus Host Disease	5 years	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.
Cumulative Incidence of Infectious Complications	1 year	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.

Trial Locations

Locations (1)

Instituto Nacional de Cancer; 🇧🇷 Rio de Janeiro, Brazil