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.
Medical College of Wisconsin
Collaborator: National Marrow Donor Program
- Biological: Haploidentical Bone Marrow Transplant
- Biological: Double Umbilical Cord Blood Transplant
- 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
- 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
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. 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
- Patients with suitably matched related or unrelated donor, as defined per
- Recipients of prior autologous hematopoietic stem cell transplantation are ineligible
if disease recurrence occurred less than 6 months from their autologous stem cell
- 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
- 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