Trial Search Results

Double Cord Versus Haploidentical (BMT CTN 1101)

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medical College of Wisconsin

Collaborator: National Marrow Donor Program

Intervention(s):

  • Biological: Haploidentical Bone Marrow Transplant
  • Biological: Double Umbilical Cord Blood Transplant

Phase:

Phase 3

Eligibility


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). At least low resolution
   DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential
   haploidentical sibling 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.

   - Acute Lymphoblastic Leukemia (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(1;19), t(4;11), other Mixed Lineage Leukemia
   (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

   - Acute Myelogeneous Leukemia (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-ITD, normal karyotype with double mutated CEBPA, Acute promyelocytic
   leukemia (APL) in first molecular remission at end of consolidation

   - Acute Leukemias in 2nd or subsequent CR

   - Biphenotypic/Undifferentiated/Prolymphocytic 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: Chemotherapy-sensitive (at least stable
   disease lymphomas that have failed at least 1 prior regimen of multi-agent
   chemotherapy and are INELIGIBLE for an autologous transplant. Patients with chronic
   lymphocytic leukemia (CLL) are not eligible regardless of disease status.

   - Performance status: Karnofsky score greater than or equal to 70%.

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. Alanine aminotransferase (ALT),
   aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit
   of normal; 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: Diffusing capacity of the lung for
   carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in one
   second (FEV1), and forced vital capacity (FVC) greater than 50% predicted;

   - 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:

      1. Patients must have available two UCB units fulfilling the following criteria:

         1. 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 x10^7/kg.

         2. 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).

         3. Additional graft selection criteria specified in section 2.5

      2. Patients must have received at least one cycle of the cytotoxic chemotherapy
      regimens (or regimen of similar intensity) listed in Appendix D within 3 months
      of enrollment (measured from the start date of chemotherapy) OR have had an
      autologous transplant within 24 months of enrollment OR receive 300 cGy as part
      of the preparative regimen

Exclusion Criteria:

   - Patients with suitably matched related or unrelated donor, as defined per
   institutional practice.

   - Recipients of prior autologous hematopoietic stem cell transplantation are ineligible
   if disease recurrence occurred less than 6 months from their autologous stem cell
   transplant.

   - 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.

Additional exclusion criteria:

   - Pregnancy or breast-feeding.

   - Evidence of HIV infection or known HIV positive serology.

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822
Recruiting