Clinical trial NCT00270881: Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Official title: Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Keywords: cord blood transplantation
myeloablative regimen
hematologic malignancies
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2005-12-29
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
measure: Non-relapse mortality at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Engraftment
timeFrame: day 56
measure: Disease free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Incidence of acute and chronic graft-versus-host disease
timeFrame: day100 and 1 year
measure: Incidence of infectious complication
timeFrame: 1year
measure: Duration of hospitalization
timeFrame: 1 year
measure: Immune reconstitution after transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University School of Medicine
Study officials:
affiliation: Tokyo Metropolitan Komagome Hospital
name: Hisashi Sakamaki, M.D., Ph.D.
role: STUDY_CHAIR
References: