Adult Double Cord Blood Transplant Study

C

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status and phase

Completed
Phase 2

Conditions

Hematologic Malignancies
Cord Blood Stem Cell Transplantation

Treatments

Procedure: Cord blood transplantation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00514579
05-DCB

Details and patient eligibility

About

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%.

Enrollment

56 patients

Sex

All

Ages

22 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 1 patient group

Myeloablative double unit UCBT
Other group
Description:
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Treatment:
Procedure: Cord blood transplantation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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