Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

April 29, 2016 updated by: Leonardo Javier Arcuri
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute leukemias referred for stem cell transplantation without HLA-matched related or unrelated donor

Description

Inclusion Criteria:

  • Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria:

  • Severe comorbidities
  • Second transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Acute Lymphoblastic Leukemia

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)
Procedure: Haploidentical Stem Cell Transplantation
Haploidentical Stem Cell Transplantation from a related donor (partially matched sibling, father, mother, son or daughter).
Group B: Acute Myeloid Leukemia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year
1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of leukemia relapse
Time Frame: 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.
5 years
Transplant Related Mortality
Time Frame: 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.
6 months
Cumulative Incidence of acute Graft Versus Host Disease
Time Frame: 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.
5 years
Cumulative Incidence of chronic Graft Versus Host Disease
Time Frame: 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.
5 years
Cumulative Incidence of Infectious Complications
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonardo Javier Arcuri

Investigators

  • Principal Investigator: Leonardo J Arcuri, MD, Instituto Nacional de Câncer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMO/INCA-Haplo-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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