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A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation


Phase 1/Phase 2
12 Years
60 Years
Not Enrolling
Both
Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia

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Trial Information

A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation


Inclusion Criteria:



- Do not have identical or 5/6 related matched bone marrow, peripheral blood or
umbilical cord

- Stable disease and lack of unrelated donor

- Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first
remission with high risk features

- ALL in 2nd or subsequent remission or first remission with high risk features

- Myelodysplastic syndrome (MDS)

- Non-Hodgkin Lymphoma (NHL)

- Chronic Myelogenous Leukemia (CML)

- Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

- Females who are pregnant

- Poor ability to perform daily activities

- Weight under 40 kilograms (88 pounds)

- AML caused by chemoradiation

- Prior stem cell transplant

- Uncontrolled infection at time of transplant

- Active fungal infection

- HIV infection

- Primary myelofibrosis

- Receiving other research drugs

- Unable to provide informed consent

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Kurt Gunter, MD

Investigator Role:

Study Director

Investigator Affiliation:

ViaCell

Authority:

United States: Food and Drug Administration

Study ID:

CB001

NCT ID:

NCT00089596

Start Date:

March 2004

Completion Date:

October 2006

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin Lymphoma
  • Chronic Myelogenous Leukemia
  • umbilical cord blood
  • transplant
  • ALL
  • AML
  • MDS
  • NHL
  • CML
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Loyola University Medical Center Maywood, Illinois  60153
Hackensack University Medical Center Hackensack, New Jersey  07601