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
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- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Cumulative incidence of relapse [ Time Frame: 3 years ]
- leukemia free survival [ Time Frame: 3 years ]
- engraftment rate [ Time Frame: 100 days ]
- donor chimerism [ Time Frame: 1year, 2year, 3year ]
- secondary graft failure rate [ Time Frame: 100days, 1year ]
- Incidence & severity of acute GVHD [ Time Frame: 100 days ]
- incidence and severity of chronic GVHD [ Time Frame: 1year, 2year, 3year ]
- degree of immune recovery [ Time Frame: 6 months, 1year ]
- cumulative incidence and severity of infection [ Time Frame: 3years ]
- transplantation-related mortality rate [ Time Frame: 3 years ]
- overall survival rate & median survival time [ Time Frame: 3 years ]
- 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|
- 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.
- 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)
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
|Korea, Republic of|
|Inje University Haeundae Paik Hospital|
|Pusan, Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|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|
|Responsible Party:||Dae-Young Kim, Assistant Professor, Asan Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 23, 2009 Key Record Dates|
|Last Update Posted:||July 20, 2018|
|Last Verified:||July 2018|
acute lymphoid leukemia
primary complete remission
secondary complete remission
allogeneic hematopoietic cell transplantation
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases