Leukemia Clinical Trial
Official title:
Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study
Verified date | December 2015 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell
transplant helps stop the growth of cancer cells. It also helps stop the patient's immune
system from rejecting the donor's stem cells. When the healthy stem cells from a donor are
infused into the patient they may help the patient's bone marrow make stem cells, red blood
cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can
make an immune response against the body's normal cells. Giving cyclosporine and
methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow
transplant works in treating patients with acute myeloid leukemia in remission.
Status | Completed |
Enrollment | 263 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 75 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: - Achieved complete response (CR1) after induction chemotherapy - Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT - No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17) - Must have a donor available meeting one of the following criteria: - HLA-matched sibling of 65 years or younger - 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR - HLA-mismatched family member (offspring, parents, haploidentical sibling) PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Bilirubin < 2.0 mg/dL - AST < 3 times the upper limit of normal - Creatinine < 2.0 mg/dL - Ejection fraction > 40% on MUGA scan - Negative pregnancy test PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inje University - Haeundae Paik Hospital | Busan | |
Korea, Republic of | Asan Medical Center - University of Ulsan College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the treatment measured in terms of frequency of relapse and duration of remission | duration of CR, leukemia recurrence | up to 2 years after transplantation | No |
Secondary | Engraftment | achievement of neutrophil count over 500/ul | up to 35 days after transplantation | Yes |
Secondary | Acute and chronic graft-versus-host disease | up to 100 days for acute GVHD and up to 2 years for chronic GVHD | Yes | |
Secondary | Treatment-related mortality | up to 2 years after transplantation | Yes | |
Secondary | Leukemia-free survival and overall survival | up to 2 years after transplantation | No |
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