| August 8, 2007 |
| October 23, 2009 |
| August 2007 |
| August 2012 (final data collection date for primary outcome measure) |
| Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [ Time Frame: One year ] [ Designated as safety issue: Yes ] |
| Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [ Time Frame: One year ] |
| Complete list of historical versions of study NCT00514579 on ClinicalTrials.gov Archive Site |
- Measure incidence of donor-derived neutrophil and platelet recovery [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ]
- Measure contribution of each unit to initial and sustained engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Measure incidence and severity of acute graft-versus-host disease [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ]
- Measure incidence and severity of chronic GVHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Measure incidence of transplant-related mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Measure incidence of malignant relapse [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Measure incidence of serious infectious complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Measure incidence of immune reconstitution [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Measure probability of overall and disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|
- Measure incidence of donor-derived neutrophil and platelet recovery [ Time Frame: 100 Days ]
- Measure contribution of each unit to initial and sustained engraftment [ Time Frame: 2 years ]
- Measure incidence and severity of acute graft-versus-host disease [ Time Frame: 100 Days ]
- Measure incidence and severity of chronic GVHD [ Time Frame: 1 year ]
- Measure incidence of transplant-related mortality [ Time Frame: 6 months ]
- Measure incidence of malignant relapse [ Time Frame: 2 years ]
- Measure incidence of serious infectious complications [ Time Frame: 1 year ]
- Measure incidence of immune reconstitution [ Time Frame: 2 years ]
- Measure probability of overall and disease-free survival [ Time Frame: 2 years ]
|
| |
| 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%. |
| |
| Phase II |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
- Cord Blood Stem Cell Transplantation
- Hematologic Malignancies
|
| Procedure: Cord blood transplantation |
| |
| |
| |
| Recruiting |
| 55 |
| August 2012 |
| August 2012 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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
|
| Both |
| 22 Years to 50 Years |
| No |
|
|
| United States |
| |
| NCT00514579 |
| Roberta King, MPH Vice President of CIBMTR, National Marrow Donor Program |
| 05-DCB |
| Center for International Blood and Marrow Transplant Research |
|
| Principal Investigator: |
Juliet Barker, MBBS |
Memorial Sloan-Kettering Cancer Center |
|
|
| Center for International Blood and Marrow Transplant Research |
| October 2009 |