Skip to main content
OpenTrials
Completed

NCT Number: NCT00514579

Adult Double Cord Blood Transplant Study

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%.

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cord blood transplantation

Procedure

Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation

Primary outcomes

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

    Time frame: One year

Secondary outcomes

  1. Measure incidence of donor-derived neutrophil and platelet recovery

    Time frame: 100 Days

  2. Measure contribution of each unit to initial and sustained engraftment

    Time frame: 2 years

  3. Measure incidence and severity of acute graft-versus-host disease

    Time frame: 100 Days

  4. Measure incidence and severity of chronic GVHD

    Time frame: 1 year

  5. Measure incidence of transplant-related mortality

    Time frame: 6 months

  6. Measure incidence of malignant relapse

    Time frame: 2 years

  7. Measure incidence of serious infectious complications

    Time frame: 1 year

  8. Measure incidence of immune reconstitution

    Time frame: 2 years

  9. Measure probability of overall and disease-free survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2007
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.