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


Phase 1/Phase 2
20 Years
55 Years
Not Enrolling
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Non-relapse mortality at 1 year

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Hisashi Sakamaki, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Tokyo Metropolitan Komagome Hospital

Authority:

Japan: Institutional Review Board

Study ID:

KSGCT-CB2005

NCT ID:

NCT00270881

Start Date:

January 2006

Completion Date:

January 2011

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • cord blood transplantation
  • myeloablative regimen
  • hematologic malignancies
  • 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

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