Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270881
• Other study ID #: KSGCT-CB2005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 28, 2005
• Last updated: April 5, 2012
• Start date: January 2006
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Keio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Procedure:
• Cord blood transplantation
unrelated cord blood transplantation

Radiation:
• TBI
Total body irradiation (TBI) 12Gy

Drug:
• cyclophosphamide
cyclophosphamide 120mg/kg
• cytarabine
cytarabine 3g/m2x4

Locations

Country	Name	City	State
Japan	Keio University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-relapse mortality at 1 year		1 year	Yes
Secondary	Engraftment		day 56	Yes
Secondary	Disease free survival		1 year	Yes
Secondary	Overall survival		1 year	Yes
Secondary	Incidence of acute and chronic graft-versus-host disease		day100 and 1 year	Yes
Secondary	Incidence of infectious complication		1year	Yes
Secondary	Duration of hospitalization		1 year	No
Secondary	Immune reconstitution after transplantation		1 year	No