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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01037764
First received: December 22, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

[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 Intervention Phase
Acute Lymphoid Leukemia
Procedure: alloHCT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Cumulative incidence of relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • leukemia free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • engraftment rate [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • donor chimerism [ Time Frame: 1year, 2year, 3year ] [ Designated as safety issue: No ]
  • secondary graft failure rate [ Time Frame: 100days, 1year ] [ Designated as safety issue: Yes ]
  • Incidence & severity of acute GVHD [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • incidence and severity of chronic GVHD [ Time Frame: 1year, 2year, 3year ] [ Designated as safety issue: Yes ]
  • degree of immune recovery [ Time Frame: 6 months, 1year ] [ Designated as safety issue: Yes ]
  • cumulative incidence and severity of infection [ Time Frame: 3years ] [ Designated as safety issue: Yes ]
  • transplantation-related mortality rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • overall survival rate & median survival time [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • duration of remission [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037764

Contacts
Contact: Ji-Young Min, R.N. 82-2-3010-7290 miracleminjy@naver.com
Contact: Seo Hyun Na, R.N. 82-2-3010-8261 claudiana@naver.com

Locations
Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Yeon-Joo Lee, RN    82-10-3342-3043    joop75@lycos.co.kr   
Principal Investigator: Young-Don Joo, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Ji-Young Min, RN    82-2-3010-7290    miracleminjy@naver.com   
Sub-Investigator: Kyoo-Hyung Lee, M.D. & PhD         
Sub-Investigator: Je-Hwan Lee, M.D. & PhD         
Sub-Investigator: Jung-Hee Lee, M.D. & PhD.         
Principal Investigator: Dae-Young Kim, M.D.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Dae-Young Kim, M.D. 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
  More Information

Publications:

Responsible Party: Dae-Young Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01037764     History of Changes
Other Study ID Numbers: AMC-ALLO-036
Study First Received: December 22, 2009
Last Updated: July 8, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
acute lymphoid leukemia
primary complete remission
secondary complete remission
postremission therapy
allogeneic hematopoietic cell transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014