NCT02759822

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

April 22, 2016

Last Update Submit

April 29, 2016

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Keywords

Haploidentical Hematopoietic Stem Cell TransplantationPartially Matched Hematopoietic Stem Cell TransplantationPost-transplant CyclophosphamideHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.

    1 year

Secondary Outcomes (5)

  • Cumulative incidence of leukemia relapse

    5 years

  • Transplant Related Mortality

    6 months

  • Cumulative Incidence of acute Graft Versus Host Disease

    5 years

  • Cumulative Incidence of chronic Graft Versus Host Disease

    5 years

  • Cumulative Incidence of Infectious Complications

    1 year

Study Arms (2)

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

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

Interventions

Haploidentical Stem Cell TransplantationPROCEDURE

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

Group A: Acute Lymphoblastic LeukemiaGroup B: Acute Myeloid Leukemia

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Acute lymphoblastic leukemia or acute myeloid leukemia

You may not qualify if:

  • Severe comorbidities
  • Second transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Leonardo J Arcuri, MD

    Instituto Nacional de Cancer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonado J Arcuri, MD

CONTACT

+55(21)32071304leonardojavier@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 3, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2021

Last Updated

May 3, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)