Clinical trial · Interventional
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
NCT00514579CI-TRIAL-00013983completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cord Blood Stem Cell Transplantation | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cord blood transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Myeloablative double unit UCBT
- description
- Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
- interventionNames
- Procedure: Cord blood transplantation
Primary outcomes (1)
- measure
- Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
- timeFrame
- One year
Secondary outcomes (9)
- measure
- Measure incidence of donor-derived neutrophil and platelet recovery
- timeFrame
- 100 Days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.