Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

L

Leonardo Javier Arcuri

Status

Unknown

Conditions

Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatments

Procedure: Haploidentical Stem Cell Transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT02759822
CEMO/INCA-Haplo-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

1 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion criteria

  • Severe comorbidities
  • Second transplant

Trial design

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Leonado J Arcuri, MD

Data sourced from clinicaltrials.gov

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