Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015) (ATLAS2015)

July 19, 2018 updated by: Dae-Young Kim, Asan Medical Center

A Prospective Study Evaluating the Efficacy of the Allogeneic Hematopoietic Cell Transplantation With Antithymocyte Globulin (ATG)-Based Conditioning of Adult Acute Lymphoblastic Leukemia in First / Second Complete Hematologic Remission

This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic complete remission (CR).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Allogeneic hematopoietic cell transplantation (AlloHCT) is recommended as a post-remission therapy for patients with adult ALL, and reduced intensity conditioning has been tried to decrease treatment-related mortality (TRM) rate.

Recent results showed that reduced intensity conditioning can be safely and effectively used for alloHCT of adult patients with ALL. However, the reduced intensity conditioning (RIC) can increase the possibilities of hematologic relapse, especially due to the reduced anti-leukemic effect. Another challenge in performing alloHCT for ALL is the donor availability - the limited availability of matched sibling donor (MSD) and well-matched unrelated donor (WMUD) forces us to find the feasibility of alternative donors such as partially-matched unrelated donor (PMUD) or haploidentical familial donor (familial mismatched donor, FMD).

The previous study (NCT0137764) which the investigators performed showed that the use of RIC and alternative donor was feasible. However, the incidence of relapse was slightly higher among patients who received RIC when the investigators analyzed the interim analysis results. Especially, the graft-versus-host disease (GVHD) incidence was relatively higher among patients who received alloHCT from MSD, and the investigators think that the addition of antithymocyte globulin will reduce the incidence of GVHD for these patients.

In this study, the dose of busulfan will be increased when the recipients are below 55 years old, irrespective of donor type. The investigators will also define the partially matched donor exactly and find the feasibility of PMUD and FMD again. Another endpoint for this study is to find out whether the addition of antithymocyte globulin may be helpful in preventing the GVHD incidence for patients who received alloHCT from MSD without increasing the chance of hematologic relapse.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of
        • Inje University Haeundae Paik Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center, University of Ulsan College of Medicine
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital, University of Ulsan College of Medicine

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are diagnosed as acute lymphoblastic leukemia, who achieve hematologic complete remission for the first time or for the second time after chemotherapy, and who wil receive allogeneic hematopoietic cell transplantation

Description

Inclusion Criteria:

  • Patients who has been previously diagnosed as one of the following disease;

    • Acute lymphoblastic leukemia
    • Biphenotypic acute leukemia with Philadelphia-positive chromosome or gene translocation

  • Patients whose disease status is one of the following;

    • First hematologic complete remission (HCR1)
    • Second hematologic complete remission (HCR2)
  • 15 years of age and over.
  • With a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor)
  • Adequate cardiac function (EF>45% via cardiac scan or EchoCG)
  • European Clinical Oncology Group (ECOG) performance status ≥grade 2 or Karnofsky scale >60% at the time of screening
  • All patients give written informed consent according to guidelines at institution's committee on human research.

Exclusion Criteria:

  • Acute lymphoblastic leukemia L3 type (Burkitt leukemia/lymphoma)
  • Biphenotypic acute leukemia without BCR-ABL1 translocation
  • Lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate)
  • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
  • Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
  • Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
  • Patients with a diagnosis of prior malignancy (including hematologic malignancies such as acute leukemia, lymphoma, multiple myeloma, and myelodysplastic syndrome, etc) unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Young/MSD
Patients who are <55 years old, and will receive alloHCT for Young/MSD
Procedure: AlloHCT for Young/MSD
Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Cyclophosphamide 60 mg/kg (D-3 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)
Young/MUD&FMD
Patients who are <55 years old, and will receive alloHCT for Young/MUD&FMD
Procedure: AlloHCT for Young/MUD&FMD
Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)
Old/MSD
Patients who are >=55 years old, and will receive alloHCT for Old/MSD
Procedure: AlloHCT for Old/MSD
Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)
Old/MUD&FMD
Patients who are >=55 years old, and will receive alloHCT for Old/MUD&FMD
Procedure: AlloHCT for Old/MUD&FMD
Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse-free survival (RFS) rate
Time Frame: 2 years
time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse-free survival (RFS) rate
Time Frame: 5 years
time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse
5 years
overall survival (OS) rate
Time Frame: 2 years
time from the diagnosis of disease to death/ time from the enrollment of this trial to death
2 years
overall survival (OS) rate
Time Frame: 5 years
time from the diagnosis of disease to death/ time from the enrollment of this trial to death
5 years
cumulative incidence of relapse
Time Frame: 2 years
from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse
2 years
cumulative incidence of relapse
Time Frame: 5 years
from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse
5 years
treatment-related mortality rate
Time Frame: 100 days
after enrollment of this trial
100 days
treatment-related mortality rate
Time Frame: 1 year
after enrollment of this trial
1 year
treatment-related mortality rate
Time Frame: 2 years
after enrollment of this trial
2 years
treatment-related mortality rate
Time Frame: 5 years
after enrollment of this trial
5 years
cumulative incidence of acute graft-versus-host disease
Time Frame: 100 days
after enrollment of this trial
100 days
cumulative incidence of acute graft-versus-host disease
Time Frame: 1 year
after enrollment of this trial
1 year
cumulative incidence of acute graft-versus-host disease
Time Frame: 2 years
after enrollment of this trial
2 years
cumulative incidence of acute graft-versus-host disease
Time Frame: 5 years
after enrollment of this trial
5 years
cumulative incidence of chronic graft-versus-host disease
Time Frame: 100 days
after enrollment of this trial
100 days
cumulative incidence of chronic graft-versus-host disease
Time Frame: 1 year
after enrollment of this trial
1 year
cumulative incidence of chronic graft-versus-host disease
Time Frame: 2 years
after enrollment of this trial
2 years
cumulative incidence of chronic graft-versus-host disease
Time Frame: 5 years
after enrollment of this trial
5 years
molecular relapse-free survival
Time Frame: 2 years
after enrollment of this trial / after achieving molecular CR (for Ph-positive ALL)
2 years

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Dae-Young Kim, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-ALLO-044

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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