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

NCT02428517 | Terminated

• 1 other identifier: AMC-ALLO-044
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Keywords

acute lymphoblastic leukemia; allogeneic hematopoietic stem cell transplantation; alternative hematopoietic stem cell donor; busulfan; antithymocyte globulin

Outcome Measures

Primary Outcomes (1)

• relapse-free survival (RFS) rate

  time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse

  2 years

Secondary Outcomes (18)

• relapse-free survival (RFS) rate

  5 years

• overall survival (OS) rate

  2 years

• overall survival (OS) rate

  5 years

• cumulative incidence of relapse

  2 years

• cumulative incidence of relapse

  5 years

Study Arms (4)

Young/MSD

Patients who are \<55 years old, and will receive alloHCT for Young/MSD

Procedure: AlloHCT for Young/MSD

Young/MUD&FMD

Patients who are \<55 years old, and will receive alloHCT for Young/MUD\&FMD

Procedure: AlloHCT for Young/MUD&FMD

Old/MSD

Patients who are \>=55 years old, and will receive alloHCT for Old/MSD

Procedure: AlloHCT for Old/MSD

Old/MUD&FMD

Patients who are \>=55 years old, and will receive alloHCT for Old/MUD\&FMD

Procedure: AlloHCT for Old/MUD&FMD

Interventions

AlloHCT for Young/MSD PROCEDURE

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/MSD

AlloHCT for Young/MUD&FMD PROCEDURE

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)

Young/MUD&FMD

AlloHCT for Old/MSD PROCEDURE

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/MSD

AlloHCT for Old/MUD&FMD PROCEDURE

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)

Old/MUD&FMD

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (4)

Inje University Busan Paik Hospital

Busan, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Location

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, South Korea

Location

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MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dae-Young Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

KR (4)