Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)

Completed · Phase 2

Conditions studied: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

In brief

A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.

Key facts

Study ID

NCT00864227

Run by

Medical College of Wisconsin

People needed

54

Starts

2008-12-01

Expected to finish

2013-11-01

Last updated by the study team

2022-12-14

Who can join

Age: 1 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Each unit must supply a minimum of 1.5 x 10\^7/kg pre-cryopreserved nucleated cell dose
• Participants must have two partially human leucocyte antigen (HLA)-matched umbilical cord blood units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0 to 2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. Each unit must be a 4 to 6 HLA-A, B, and DRB1 antigen matched to each other, not necessarily at the same loci as with the recipient. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 for this study. An adult 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.
• 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:
• Heart: left ventricular ejection fraction at rest greater than 35%, or shortening fraction greater than 25%
• Liver: bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than or equal to five times the upper limit of normal
• 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) greater than 40 mL/min/1.73m\^2
• Lungs: 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.

You may not qualify if…

• Have an HLA-matched, related, or 7 or 8/8 HLA 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of Florida College of Medicine, Shands — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Dana-Farber Cancer Institute (DFCI), Brigham & Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute (DFCI), Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University, Barnes Jewish Hospital — St Louis, Missouri, United States
• Weill Cornell Medical College, NY Presbyterian Hospital — New York, New York, United States
• Ohio State, Arthur G. James Cancer Hospital — Columbus, Ohio, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Virginia Commonwealth University, Medical College of Virginia (MCV) Hospital — Richmond, Virginia, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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