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A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From HLA Compatible Unrelated Donors.


Phase 3
18 Years
66 Years
Not Enrolling
Both
Blood Stem Cell Transplant

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Trial Information

A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From HLA Compatible Unrelated Donors.


This study is a randomized, open-label, multicenter, prospective, comparative trial of
granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses
marrow from unrelated donors for transplantation in patients with hematologic malignancies.
The study will be comparing two-year survival probabilities between process has many steps
after a matched donor is found. The donor also needs to give permission to join this study.
Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow.
The kind of transplant the participant receives is random. Neither the participant nor the
doctor may choose the type of transplant.

Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and
pneumococcus. Blood samples will be drawn as part of a participant's normal care. Blood
samples will also be collected to see if infection fighting cells are working. These samples
will be collected at 12 weeks, one year and then yearly until three years post transplant.
Information will be collected from the participant's medical history. Participants will also
have phone interviews conducted and questions will be asked about their physical and
emotional health. Participants taking part in this study may be followed for up to 5 years.

Inclusion Criteria


Participants may be eligible if they are between the ages of 18 to 66 years and are
undergoing unrelated blood stem cell transplantation for the first time for the treatment
of their hematological malignancy. Additional eligibility criteria will be gathered and
evaluated by the transplant physician to determine if an individual is eligible to take
part.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two-year survival

Outcome Description:

The primary objective is to compare two-year survival probabilities between patients in the two study arms using an intent-to-treat analysis

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Shakila P. Khan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

2158-03

NCT ID:

NCT00275678

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Blood Stem Cell Transplant
  • Hematologic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905