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Completed

NCT Number: NCT00270881

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

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.

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Key information

Conditions

Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Bone Marrow Diseases Chronic Disease Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Keio University School of Medicine

Tokyo, 160-8582, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cord blood transplantation

Procedure

unrelated cord blood transplantation

TBI

Radiation

Total body irradiation (TBI) 12Gy

Cyclophosphamide

Drug

cyclophosphamide 120mg/kg

Cytarabine

Drug

cytarabine 3g/m2x4

Primary outcomes

  1. Non-relapse mortality at 1 year

    Time frame: 1 year

Secondary outcomes

  1. Engraftment

    Time frame: day 56

  2. Disease free survival

    Time frame: 1 year

  3. Overall survival

    Time frame: 1 year

  4. Incidence of acute and chronic graft-versus-host disease

    Time frame: day100 and 1 year

  5. Incidence of infectious complication

    Time frame: 1year

  6. Duration of hospitalization

    Time frame: 1 year

  7. Immune reconstitution after transplantation

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Keio University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Dec 29, 2005
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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