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

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ClinicalTrials.gov Identifier: NCT01037764
Recruitment Status : Terminated (The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.)
First Posted : December 23, 2009
Last Update Posted : July 20, 2018
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Lymphoid Leukemia Procedure: alloHCT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia in Remission Using HLA-matched Sibling Donors, HLA-matched Unrelated Donors, or HLA-mismatched Familial Donors-A Phase 2 Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: alloHCT
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

[ 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.

Other Name: allogeneic hematopoietic stem cell transplantation

Primary Outcome Measures :
  1. Cumulative incidence of relapse [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. leukemia free survival [ Time Frame: 3 years ]
  2. engraftment rate [ Time Frame: 100 days ]
  3. donor chimerism [ Time Frame: 1year, 2year, 3year ]
  4. secondary graft failure rate [ Time Frame: 100days, 1year ]
  5. Incidence & severity of acute GVHD [ Time Frame: 100 days ]
  6. incidence and severity of chronic GVHD [ Time Frame: 1year, 2year, 3year ]
  7. degree of immune recovery [ Time Frame: 6 months, 1year ]
  8. cumulative incidence and severity of infection [ Time Frame: 3years ]
  9. transplantation-related mortality rate [ Time Frame: 3 years ]
  10. overall survival rate & median survival time [ Time Frame: 3 years ]
  11. duration of remission [ Time Frame: 3 years ]

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037764

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Korea, Republic of
Inje University Haeundae Paik Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Dae-Young Kim, M.D. & PhD Asan Medical Center
Study Chair: Kyoo-Hyung Lee, M.D. & PhD. Asan Medical Center
Study Director: 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

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Responsible Party: Dae-Young Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01037764    
Other Study ID Numbers: AMC-ALLO-036
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Keywords provided by Dae-Young Kim, Asan Medical Center:
acute lymphoid leukemia
primary complete remission
secondary complete remission
postremission therapy
allogeneic hematopoietic cell transplantation
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases