Donor-specific Allogeneic Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) (AHCTALL)
- 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.
|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|
- Cumulative incidence of relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ]
|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)|
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.
[ 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
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|Contact: Ji-Young Min, R.N.||email@example.com|
|Contact: Seo Hyun Na, R.N.||firstname.lastname@example.org|
|Korea, Republic of|
|Inje University Haeundae Paik Hospital||Recruiting|
|Pusan, Korea, Republic of|
|Contact: Yeon-Joo Lee, RN 82-10-3342-3043 email@example.com|
|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 firstname.lastname@example.org|
|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.|
|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|