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


Phase 2
22 Years
50 Years
Open (Enrolling)
Both
Cord Blood Stem Cell Transplantation, Hematologic Malignancies

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure overall survival of double unit UCBT in adult patients with hematologic malignancies

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Juliet Barker, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-DCB

NCT ID:

NCT00514579

Start Date:

August 2007

Completion Date:

October 2013

Related Keywords:

  • Cord Blood Stem Cell Transplantation
  • Hematologic Malignancies
  • Cord Blood Stem Cell Transplantation
  • Hematologic Malignancies
  • Leukemia
  • Myelodysplastic Syndrome
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of OklahomaOklahoma City, Oklahoma  73190
City of HopeDuarte, California  91010
Duke University Medical CenterDurham, North Carolina  27710
Case Western Reserve UniversityCleveland, Ohio  44106
Ohio State University Medical CenterColumbus, Ohio  43210
University of California at Los AngelesLos Angeles, California  90095
Blood and Marrow Transplant Program at Northside HospitalAtlanta, Georgia  30342
University of Wisconsin-MadisonMadison, Wisconsin  53792