Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
This study has been completed.
Sponsor:
Keio University
Information provided by (Responsible Party):
Takehiko Mori, M.D., Ph.D., Keio University
ClinicalTrials.gov Identifier:
NCT00270881
First received: December 28, 2005
Last updated: April 5, 2012
Last verified: April 2012
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Purpose
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome |
Procedure: Cord blood transplantation Radiation: TBI Drug: cyclophosphamide Drug: cytarabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Keio University:
Primary Outcome Measures:
- Non-relapse mortality at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Engraftment [ Time Frame: day 56 ] [ Designated as safety issue: Yes ]
- Disease free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Incidence of acute and chronic graft-versus-host disease [ Time Frame: day100 and 1 year ] [ Designated as safety issue: Yes ]
- Incidence of infectious complication [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
- Duration of hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Immune reconstitution after transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Cord blood transplantation
unrelated cord blood transplantation
Radiation: TBI
Total body irradiation (TBI) 12Gy
Drug: cyclophosphamide
cyclophosphamide 120mg/kg
Drug: cytarabine
cytarabine 3g/m2x4
Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
- Lack of HLA-identical or 1 locus mismatched related donor
- Age over 20, and under 55
- Performance status 0 or 1
- No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
- No anti-HLA antibody
- Informed consent was obtained
Exclusion Criteria:
- Uncontrollable diabetes
- Uncontrollable hypertension
- Active infection
- TPHA, HBs-Ag, HCV-Ab positive
- HTLV-I, HIV positive
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takehiko Mori, M.D., Ph.D., Dr., Keio University |
| ClinicalTrials.gov Identifier: | NCT00270881 History of Changes |
| Other Study ID Numbers: | KSGCT-CB2005 |
| Study First Received: | December 28, 2005 |
| Last Updated: | April 5, 2012 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Keio University:
|
cord blood transplantation myeloablative regimen hematologic malignancies |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site Cyclophosphamide Cytarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on May 22, 2013