Adult Double Cord Blood Transplant Study

A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy

The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.

Inclusion Criteria:

• Age 22 - 50 years

• Patients will have one of the following hematological malignancies:

  • Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
  • Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
  • Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
  • Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS

• Patients with adequate organ function and performance status criteria

• Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.

Exclusion Criteria:

• Patient with suitable related donor

• AML, ALL, AUL, biphenotypic leukemia beyond CR2

• AML evolved from myelofibrosis

• Any acute leukemia with:

  • Morphologic relapse or persistent disease in the BM
  • Active extra-medullary leukemia including active CNS leukemia
  • Requiring greater than two cycles of chemotherapy to obtain present remission status

• Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)

• MDS with 10% or greater bone marrow blasts at pre-transplant workup

• Prior autologous or allogeneic HSC transplant at any time

• Prior radiation therapy rendering patient ineligible for TBI

• Any uncontrolled infection at time of study enrollment

• Seropositive or NAT positive for HIV or HTLV1

• Females who are pregnant or breast feeding

• Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests