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Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders


N/A
N/A
N/A
Open (Enrolling)
Both
Hematological Malignancy, Bone Marrow Failure Syndrome

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Trial Information

Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders


Inclusion Criteria:



Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital
or the BCCA-Vancouver.

Eligible patients will have one of the following underlying diseases:

- High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high
risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients
presenting with extreme hyperleukocytosis (WBC >100x109/L) or failure to achieve a
complete remission after standard induction therapy.

- Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics
or failure to achieve complete remission after standard induction therapy. ALL or AML
in second or subsequent remission

- Myelofibrosis with myeloid metaplasia.

- Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated
phase.

- Myelodysplastic syndrome with IPSS risk category >Int-1

- Aplastic anemia

- Non-Hodgkin's lymphoma, chronic lymphocytic leukemia or Hodgkin's disease in relapse
or second or subsequent remission.

- Multiple Myeloma

- No active central nervous system (CNS) disease.

- No 9/10 or better HLA antigen matched related donor or VUD available.

- The patient's condition precludes waiting to search and find a VUD in the Unrelated
Donor Registries

- Acceptance of standard blood product support

- Adequate organ function as defined by current Leukemia/BMT Program of BC standards
(Appendix 10.1)

- Karnofsky performance status ≥ 80 (Appendix 10.2)

Exclusion Criteria:

- Active infection

- Pregnancy

- Significant psychiatric disorder

- Progressive disease

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:

To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.

Safety Issue:

No

Principal Investigator

Donna Hogge

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia - Vancouver Coastal Health Research Institute

Authority:

Canada: Health Canada

Study ID:

H08-02813

NCT ID:

NCT00897260

Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Hematological Malignancy
  • Bone Marrow Failure Syndrome
  • Unrelated Umbilical Cord Blood Transplant
  • Multiple cord blood
  • Neoplasms
  • Hematologic Diseases
  • Pancytopenia
  • Hematologic Neoplasms
  • Hemoglobinuria, Paroxysmal

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