Leukemia, Myeloid, Acute Clinical Trial
Official title:
A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow From Related Donors for Patients With Hematologic Malignancies (BMT CTN #0603)
Verified date | December 2022 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant-one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow-in people with leukemia or lymphoma.
Status | Completed |
Enrollment | 55 |
Est. completion date | November 2013 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 70 Years |
Eligibility | Inclusion Criteria: - Participants must be 21 to 70 years old; participants 1 to 21 years old are also eligible if they are ineligible for BMT CTN #0501 (NCT00412360) - Donor must be at least 18 years of age - Human leucocyte antigen (HLA) typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and -DQB1 loci. A minimum match of 5/10 is required. An unrelated donor search is not required for a person to be eligible for this study if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6 to 8 weeks from referral to transplant center or low likelihood of finding a matched, unrelated donor. The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required. - Must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of chemotherapy) - Acute leukemias (includes T lymphoblastic lymphoma) in the second or subsequent complete remission (CR) - Burkitt's lymphoma in the second or subsequent CR - Lymphoma - Patients with adequate physical function as measured by the following: 1. Heart: left ventricular ejection fraction at rest must be greater than or equal to 35%, or shortening fraction greater than 25% 2. Liver: bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than five times the upper limit of normal 3. Kidney: serum creatinine within normal range for age, or if serum creatinine is outside the normal range for age, then kidney function (creatinine clearance or glomerular filtration rate (GFR) is greater than 40 mL/min/1.73m^2 4. Pulmonary: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusing capacity (DLCO) greater than 50% predicted (corrected for hemoglobin). If unable to perform pulmonary function tests, then oxygen (O2) saturation must be greater than 92% on room air. 5. Performance status: Karnofsky/Lansky score greater than or equal to 60% Exclusion Criteria: - Have an HLA-matched, related, or 7 or 8/8 allele matched (HLA-A, -B, -Cw, -DRB1) related donor able to donate - Had an autologous hematopoietic stem cell transplant in the 3 months before study entry - Pregnant or breastfeeding - Evidence of HIV infection or known HIV positive serology - Current uncontrolled bacterial, viral, or fungal infection (i.e., currently taking medication with evidence of progression of clinical symptoms or radiologic findings) - Prior allogeneic hematopoietic stem cell transplant - History of primary idiopathic myelofibrosis |
Country | Name | City | State |
---|---|---|---|
United States | Bone Marrow Transplant Group of Georgia, Northside Hospital | Atlanta | Georgia |
United States | Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center (SKCCC) | Baltimore | Maryland |
United States | University of Maryland, Greenbaum Cancer Center | Baltimore | Maryland |
United States | DFCI, Massachusetts General Hospital | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Baylor University Medical Center | Dallas | Texas |
United States | Karmanos Cancer Institute, Children's Hospital of Michigan | Detroit | Michigan |
United States | City of Hope National Medical Center | Duarte | California |
United States | University of Florida College of Medicine (Shands) | Gainesville | Florida |
United States | Kapi'olani Medical Center for Women and Children, University of Hawaii | Honolulu | Hawaii |
United States | University of California San Diego Medical Center | La Jolla | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Fox Chase, Temple University | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Washington University, Barnes Jewish Hospital | Saint Louis | Missouri |
United States | Texas Transplant Institute | San Antonio | Texas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program |
United States,
Brunstein CG, Fuchs EJ, Carter SL, Karanes C, Costa LJ, Wu J, Devine SM, Wingard JR, Aljitawi OS, Cutler CS, Jagasia MH, Ballen KK, Eapen M, O'Donnell PV; Blood and Marrow Transplant Clinical Trials Network. Alternative donor transplantation after reduced — View Citation
Eapen M, O'Donnell P, Brunstein CG, Wu J, Barowski K, Mendizabal A, Fuchs EJ. Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Oct;20(10) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival at 180 Days From the Time of Transplant | Measured at Month 6 and Year 1 | ||
Secondary | Neutrophil Recovery | Cumulative incidence of neutrophil recovery >500/µL at day +56 | Measured at Days 28, 56, 90, and 100 | |
Secondary | Primary Graft Failure | Primary graft failure is defined as < 5% donor chimerism on all measurements. | Measured at Day 67 | |
Secondary | Secondary Graft Failure | Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure. | Measured at Day 100 | |
Secondary | Platelet Recovery | Platelet Recovery to 20K | Measured at Days 56, 90, and 100 | |
Secondary | Platelet Recovery | Platelet Recovery to 50K | Measured at Days 56, 90, and 100 | |
Secondary | Donor Cell Engraftment | Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism = 5% on Day = 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction. | Measured at Day 56 | |
Secondary | Acute Graft-versus-host Disease (GVHD) | Measured at Day 100 | ||
Secondary | Chronic GVHD | Measured at Year 1 | ||
Secondary | Progression-free Survival | Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up. | Measured at Year 1 | |
Secondary | Treatment-related Mortality (TRM) | Measured at 6 months and 1 year | ||
Secondary | Infections | Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant. | Measured at Year 1 |
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