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Trial record 17 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Leonardo Javier Arcuri, Instituto Nacional de Cancer, Brazil
Sponsor:
Information provided by (Responsible Party):
Leonardo Javier Arcuri, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier:
NCT02759822
First received: April 22, 2016
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention
Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Procedure: Haploidentical Stem Cell Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

Resource links provided by NLM:


Further study details as provided by Leonardo Javier Arcuri, Instituto Nacional de Cancer, Brazil:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year ]
    1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute leukemias referred for stem cell transplantation without HLA-matched related or unrelated donor
Criteria

Inclusion Criteria:

  • Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria:

  • Severe comorbidities
  • Second transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02759822

Contacts
Contact: Leonado J Arcuri, MD +55(21)32071304 leonardojavier@gmail.com

Locations
Brazil
Instituto Nacional de Cancer Recruiting
Rio de Janeiro, Brazil, 20230-130
Contact: Leonardo J Arcuri, MD    +55(21)3207-1304    leonardojavier@gmail.com   
Contact: Simone Lermontov    +55(21)3207-1261    simonelermontov@globo.com   
Sponsors and Collaborators
Leonardo Javier Arcuri
Investigators
Principal Investigator: Leonardo J Arcuri, MD Instituto Nacional de Cancer
  More Information

Responsible Party: Leonardo Javier Arcuri, Physician, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT02759822     History of Changes
Other Study ID Numbers: CEMO/INCA-Haplo-01
Study First Received: April 22, 2016
Last Updated: April 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Leonardo Javier Arcuri, Instituto Nacional de Cancer, Brazil:
Haploidentical Hematopoietic Stem Cell Transplantation
Partially Matched Hematopoietic Stem Cell Transplantation
Post-transplant Cyclophosphamide
Hematopoietic Stem Cell Transplantation

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 18, 2017