Donor-specific Allogeneic Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

NCT01037764 | Terminated Phase 2

• 1 other identifier: AMC-ALLO-036
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

\[Study Objectives\]

• To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in patients with acute lymphoblastic leukemia (ALL) in the first or second complete remission (CR). The efficacy of the treatment will be measured in terms of the frequency of relapse and duration of remission (the primary endpoints).
• The secondary end points of the study include; engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, transplantation-related mortality, leukemia free survival, and overall survival.

Conditions

Acute Lymphoid Leukemia

Keywords

acute lymphoid leukemia; primary complete remission; secondary complete remission; postremission therapy; allogeneic hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of relapse

  3 years

Secondary Outcomes (11)

• leukemia free survival

  3 years

• engraftment rate

  100 days

• donor chimerism

  1year, 2year, 3year

• secondary graft failure rate

  100days, 1year

• Incidence & severity of acute GVHD

  100 days

Study Arms (1)

alloHCT

EXPERIMENTAL

alloHCT arm: For HLA-matched sibling HCT, if a patient is 55 years old or less and without co-morbidity, the patient will receive Bu-Cy conditioning therapy and be transplanted with bone marrow cells. Patients who are older than 55 years or with co-morbidity will receive Bu-Flu-ATG conditioning and be transplanted with mobilized peripheral blood hematopoietic cells. For HLA-matched unrelated donor or HLA-mismatched familial donor HCT, the patient will receive Bu-Flu-ATG conditioning and well be transplanted with mobilized peripheral blood hematopoietic cells.

Procedure: alloHCT

Interventions

alloHCT PROCEDURE

\[ alloHCT arm \] Bu-Cy conditioning; Busulfan (Bu) 3.2 mg/kg\*/day iv daily on days -7 and -4. Cyclophosphamide (Cy) 60 mg/kg\* in D5W 200 mL iv over 1-2 hours daily on days -3 and -2. BuFluATG conditioning; Bu 3.2 mg/kg\*/day iv daily on days -7 and -6. Fludarabine (Flu) 30 mg/m2/day in D5W 100 ml iv over 30 minutes starting at 4 pm daily on days -7, -6, -5, -4, -3, and -2. Anti-thymocyte globulin (ATG, Thymoglobulin, Genzyme Transplant, Cambridge, MA, USA) 1.5 mg/kg/day (for HLA-matched sibling HCT) or 3.0 mg/kg/day (for HLA-matched unrelated donor HCT or HLA-mismatched familial donor HCT) in N/S 500-800 ml (less than 4 mg/ml) iv over 4 hours starting at 8 am daily on days , -3, -2 and -1.

Also known as: allogeneic hematopoietic stem cell transplantation

alloHCT

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ALL who achieve CR after induction chemotherapy.
• Patients with recurrent ALL that went into second CR after salvage chemotherapy, except those who had undergone allogeneic HCT previously.
• Patients should be 15 years of age or more, and 75 years of age or less.
• The performance status of the patients should be 70 or over by Karnofsky performance scale.
• Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit).
• Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
• Patients must have adequate cardiac function (ejection fraction \> 40% on MUGA scan).
• Patients must sign informed consent.

You may not qualify if:

• Presence of significant active infection
• Presence of uncontrolled bleeding
• Any coexisting major illness or organ failure
• 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
• Patients with a diagnosis of prior malignancy 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 (2)

Inje University Haeundae Paik Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (29)

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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, M.D. & PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Kyoo-Hyung Lee, M.D. & PhD.

  Asan Medical Center

  STUDY CHAIR

• Je-Hwan Lee, M.D. & PhD.

  Asan Medical Center

  STUDY DIRECTOR

• Jung-Hee Lee, M.D. & PhD.

  Asan Medical Center

  STUDY DIRECTOR

• Young-Don Joo, MD, PhD

  Inje University Haeundae Paik Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

KR (2)