Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies

This study has been completed.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

National Cancer Institute (NCI)

National Marrow Donor Program

University of Minnesota - Clinical and Translational Science Institute

University of Florida

Duke University

Ann & Robert H Lurie Children's Hospital of Chicago

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00275678

First received: January 10, 2006

Last updated: June 2, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2006

Last Updated Date

June 2, 2010

Start Date ^ICMJE

November 2003

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Two-year survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Two-year survival from the time of randomization.

Change History

Complete list of historical versions of study NCT00275678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Two-year survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Transplanted patients randomized to the two study arms will be compared for the following endpoints: survival, incidences of neutrophil and platelet engraftment, graft failure, acute graft-versus-host disease (GVHD), chronic GVHD, time off all immunosuppressive therapy, relapse, infections, adverse events, immune reconstitution, and quality of life. Donors in each arm of the study will be compared for time to return to baseline toxicity score, CBC and WBC differential values after donation and quality of life.
Neutrophil Engraftment > 500/mcl [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Primary graft failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Platelet engraftment > 20,000 and 50,000/mcl transfusion independent [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Acute GVHD of grades II-IV and III-IV [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Two-year survival
Neutrophil Engraftment > 500/mcl
Primary graft failure
Platelet engraftment > 20,000 and 50,000/mcl transfusion independent
Acute GVHD of grades II-IV and III-IV

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies

Official Title ^ICMJE

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

Brief Summary

This study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation or with those who have had bone marrow transplantation from an unrelated donor for the treatment of serious hematological malignancies.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Blood Stem Cell Transplant

Intervention ^ICMJE

Procedure: Blood stem cell versus bone marrow transplant

Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.
Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.
Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.
Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 66 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00275678

Other Study ID Numbers ^ICMJE

2158-03

Has Data Monitoring Committee

Not Provided

Responsible Party

Shakila Khan, MD, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Marrow Donor Program
University of Minnesota - Clinical and Translational Science Institute
University of Florida
Duke University
Ann & Robert H Lurie Children's Hospital of Chicago

Investigators ^ICMJE

Principal Investigator:

Shakila P. Khan, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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