Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
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)
3 other identifiers
interventional
55
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
September 7, 2015
CompletedJanuary 4, 2023
December 1, 2022
2.7 years
February 20, 2009
May 20, 2015
December 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival at 180 Days From the Time of Transplant
Measured at Month 6 and Year 1
Secondary Outcomes (11)
Neutrophil Recovery
Measured at Days 28, 56, 90, and 100
Primary Graft Failure
Measured at Day 67
Secondary Graft Failure
Measured at Day 100
Platelet Recovery
Measured at Days 56, 90, and 100
Platelet Recovery
Measured at Days 56, 90, and 100
- +6 more secondary outcomes
Study Arms (1)
Haploidentical Bone Marrow Transplant
EXPERIMENTALParticipants will receive a human leucocyte antigen (HLA) haploidentical bone marrow transplantation using a non-myeloablative preparative regimen, GVHD prophylaxis.
Interventions
The transplant preparative regimen is listed below. The - sign is the number of days before the transplant. * Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2 * Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5 * Total body irradiation (TBI): 200 centigray (cGy) on Day -1 Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor.
The GVHD prophylaxis regimen will consist of the following: * Cy: 50 mg/kg IV on Days 3 and 4 * Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL * Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID * Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm\^3 for 3 consecutive days
Eligibility Criteria
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)
- 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:
- Heart: left ventricular ejection fraction at rest must be greater than or equal to 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 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) is greater than 40 mL/min/1.73m\^2
- 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.
- Performance status: Karnofsky/Lansky score greater than or equal to 60%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
Study Sites (17)
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
University of California San Diego Medical Center
La Jolla, California, 92093, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-0277, United States
Bone Marrow Transplant Group of Georgia, Northside Hospital
Atlanta, Georgia, 30342, United States
Kapi'olani Medical Center for Women and Children, University of Hawaii
Honolulu, Hawaii, 96826, United States
University of Maryland, Greenbaum Cancer Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center (SKCCC)
Baltimore, Maryland, 21231, United States
DFCI, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute, Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
Fox Chase, Temple University
Philadelphia, Pennsylvania, 19111-2442, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8210, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Related Publications (2)
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 intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood. 2011 Jul 14;118(2):282-8. doi: 10.1182/blood-2011-03-344853. Epub 2011 Apr 28.
PMID: 21527516RESULTEapen 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):1485-92. doi: 10.1016/j.bbmt.2014.05.015. Epub 2014 May 23.
PMID: 24862638RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal
- Organization
- The EMMES Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD, MS
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 23, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2011
Study Completion
November 1, 2013
Last Updated
January 4, 2023
Results First Posted
September 7, 2015
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 6 months of official study closure at participating sites.
- Access Criteria
- Available to the public.
Results will be published in a manuscript