Double Cord Versus Haploidentical (BMT CTN 1101)

Description

Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.

Study Start Date

June 2012

Estimated Completion Date

June 2019

Interventions

  • Drug: Double Cord Blood Transplantation
  • Drug: Biological/Vaccine: Haploidentical BMT
  • Biological: Haploidentical Bone Marrow Transplant
  • Biological: Double Umbilical Cord Blood Transplant

Specialties

  • Oncology: BMT/SCT,Leukemia/Lymphoma

MeSH Terms

  • Burkitt Lymphoma
  • Hodgkin Disease
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute

Study ID

Medical College of Wisconsin -- 715

Status

Unknown

Trial ID

NCT01597778

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

410

Sponsor

Medical College of Wisconsin

Inclusion Criteria

  • Patients 18 to 70 years old
  • Patients must have available both: a)One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). Low resolution using DNA based typing at HLA-A, -B, and -DRB1 for potential haploidentical donors is required. b)At least two potential umbilical cord blood units identified. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Confirmatory typing is not required for randomization.
  • Patients must have received either: a)At least one cycle of a the following cytotoxic chemotherapy regimen (or regimen of similar intensity) within 3 months of enrollment (measured from the start date of chemotherapy)(1. multiagent chemotherapy, 2. chemotherapy regimens like those that are given as induction or consolidation of acute leukemia, 3. single drug alkylator agent. 4. single agent alemtuzumab or brentuximab vedotin)
  • or, b) Autologous HCT greater than 6 months and less than 2 years prior to enrollment.
  • ALL in first complete remission (CR1) that is NOT considered favorable-risk as defined by the presence of at least one of the following: Adverse cytogenetics such as t(9
  • 22), t(119), t(411), other MLL rearrangements White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL)at diagnosis Recipient age older than 30 years at diagnosis Time to CR greater than 4 weeks
  • AML in CR1 that is NOT considered as favorable-risk. Favorable risk is defined as having one of the following: t(8.21) without CKIT mutation, inv(16) without CKIT mutation or t(16
  • 16), normal karyotype with mutated NPM1 and not FLT-IND, normal karyotype with double mutated CEBPA, APL in first molecular remission at end of consolidation
  • Acute Leukemias in 2nd or subsequent CR
  • Biphenotypic/Undifferentiated/Prolymphocyctic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR
  • Burkitt's lymphoma: second or subsequent CR
  • Lymphoma fulfilling the following criteria: a) Chemotherapy-sensitive (complete or partial response
  • lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are INELIGIBLE for an autologous transplant b) Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least at least two prior therapies (excluding single agent Rituxan). Additional Patient Inclusion Criteria for Conditioning:
  • Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%
  • b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis. ALT, AST, and Alkaline Phosphatase less than 5 x ULN c. Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR)greater than 40 mL/min/1.73m^ d. Pulmonary: DLCO (corrected for hemoglobin), FEV1, and FVC greater than 50% predicted e. Performance status: Karnofsky score greater than or equal to 70%.
  • Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm: Patients must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. 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.
  • Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm: Patients must have available two UCB units fulfilling the following criteria: a. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg
  • and, b. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing.

Exclusion Criteria

  • Patients with suitably matched related or unrelated donor.
  • Autologous hematopoietic stem cell transplant less than 6 months prior to enrollment.
  • Pregnancy or breast-feeding.
  • Evidence of HIV infection or known HIV positive serology.
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
  • Prior allogeneic HCT.
  • Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
  • Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
  • Anti-donor HLA antibodies.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (52)

Study Location Distance Name Phone Email
Mt Sinai Medical Center - New York, New York 46.8 miles None None None
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 134.5 miles None None None
DFCI Brigham Womens Hospital - Boston, Massachusetts 135.8 miles None None None
DFCI Brigham Womens Hospital - Boston, Massachusetts 135.8 miles Corey Cutler MD 617-632-5946 corey_cutler@dfci.harvard.edu
DFCI Massachustts General Hospital - Boston, Massachusetts 137.9 miles None None None
Penn State College of Medicine The Milton S Hershey Medical Center - Hershey, Pennsylvania 188.9 miles None None None
Johns Hopkins University - Baltimore, Maryland 221.5 miles None None None
University of Rochester Medical Center - Rochester, New York 260.4 miles None None None
Roswell Park Cancer Institute - Buffalo, New York 310.8 miles None None None
Virginia Commonwealth University - Richmond, Virginia 338.8 miles None None None
Cleveland Clinic Foundation - Cleveland, Ohio 435.4 miles Matt Kalaycio MD 216-444-3705 kalaycm@ccf.org
Cleveland Clinic Foundation - Cleveland, Ohio 435.4 miles None None None
Duke University Medical Center - Durham, North Carolina 474.1 miles Joanne Kurtzberg MD None kurtz001@mc.duke.edu
Duke University Medical Center - Durham, North Carolina 474.1 miles None None None
Karmanos Cancer InstituteBMT - Detroit, Michigan 512.3 miles None None None
Ohio State Arthur G James Cancer Hospital - Columbus, Ohio 520.3 miles None None None
Wake Forest University Health Sciences - Winston-Salem, North Carolina 523.1 miles None None None
Wake Forest University Health Sciences - Winston-Salem, North Carolina 523.1 miles Sharon McFadden None smcfadde@wfubmc.edu
University of Michigan Medical Center - Ann Arbor, Michigan 545.4 miles None None None
University of Michigan Medical Center - Ann Arbor, Michigan 545.4 miles Daniel Couriel MD None dcouriel@umich.edu
Jewish Hospital BMT Program - Cincinnati, Ohio 605.5 miles Miguel IslasOhlmayer MD None mislas-ohlmayer@ohcare.com
Jewish Hospital BMT Program - Cincinnati, Ohio 605.5 miles None None None
University of Kentucky - Lexington, Kentucky 639.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 691.2 miles None None None
Medical College of Wisconsin - Milwaukee, Wisconsin 761.6 miles None None None
Medical College of Wisconsin - Milwaukee, Wisconsin 761.6 miles Marcelo Pasquini MD 414-805-0700 mpasquin@mcw.edu
BMT Program at Northside Hospital - Atlanta, Georgia 793.5 miles None None None
Emory University - Atlanta, Georgia 795.6 miles None None None
Emory University - Atlanta, Georgia 795.6 miles Edmund Waller MD None ewaller@emory.edu
Vanderbilt University Medical Center - Nashville, Tennessee 811.9 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 811.9 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 915.7 miles None None None
Florida Hospital Cancer Institute - Orlando, Florida 989.4 miles Yasser Khaled MD 407-303-2091 yasser.khaled.md@flhosp.org
Florida Hospital Cancer Institute - Orlando, Florida 989.4 miles None None None
Mayo Clinic Rochester - Rochester, Minnesota 997.5 miles None None None
Univeristy of Minnesota - Minneapolis, Minnesota 1,040.9 miles None None None
Univeristy of Minnesota - Minneapolis, Minnesota 1,040.9 miles Claudio Brunstein MD None bruns072@umn.edu
University of Kansas Hospital - Kansas City, Kansas 1,138.2 miles None None None
University of Kansas Hospital - Kansas City, Kansas 1,138.2 miles Omar Aljitawi MD 913-588-6029 oaljitawi@kumc.edu
University of Miami - Miami, Florida 1,145.6 miles None None None
University of Miami - Miami, Florida 1,145.6 miles None None None
University of Oklahoma Medical Center - Oklahoma City, Oklahoma 1,371.2 miles None None None
Univesity of Texas MD Anderson CRC - Houston, Texas 1,475.7 miles None None None
Texas Transplant Institute - San Antonio, Texas 1,635.9 miles Paul Shaughnessy MD None Paul.Shaughnessy@MHShealth.com
Colorado Blood Cancer Institute - Denver, Colorado 1,665.3 miles None None None
Mayo Clinic Phoenix - Phoenix, Arizona 2,171.7 miles None None None
Arizona Cancer Center - Phoenix, Arizona 2,184.2 miles Melissa Lim 520-626-9526 mlim@uacc.arizona.edu
Arizona Cancer Center - Phoenix, Arizona 2,184.2 miles None None None
University of California at Los Angeles - Los Angeles, California 2,499.3 miles None None None
University of California at Los Angeles - Los Angeles, California 2,499.3 miles Gary Schiller MD None gschiller@mednet.ucla.edu
Stanford Hospital and Clinics - Stanford, California 2,599.9 miles Andrew Rezvani MD None arezvani@stanford.edu
Stanford Hospital and Clinics - Stanford, California 2,599.9 miles None None None

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