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Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530581
First Posted: February 10, 2012
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
  Purpose
This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for Haematologic Malignancies.

Condition Intervention Phase
Transplantation for Hematologic Malignancies Procedure: G-PB Transplant Procedure: G-BM Transplant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 years ]
    The use of G-BM is associated with a longer time to treatment failure (extensive chronic GVHD, relapse, death) than is the use of G-PB for adult myeloablative allogeneic transplantation for hematologic malignancies.


Enrollment: 230
Study Start Date: November 2008
Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-BM Transplant Procedure: G-BM Transplant
G-BM Transplant
G-PB Transplant
G-PB Transplant
Procedure: G-PB Transplant
G-PB Transplant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipient must

    1. Be between the ages of 16 and 65 years old
    2. Have one of the following hematologic malignancies:

      • Acute myeloid leukemia (de novo, secondary or therapy related) in untreated 1st relapse or in remission or with evidence of molecular relapse but blasts less than 5%
      • Chronic myeloid leukemia in chronic or accelerated phase (de novo or therapy related)
      • Myelodysplasia (de novo or therapy related)
      • Other hematologic malignancy (de novo or therapy related) including but not limited to: ALL (CR 1, CR2 or CR3), CLL, non-Hodgkin's lymphoma, Hodgkin's lymphoma
    3. Must be receiving a myeloablative conditioning regimen of busulfan and cyclophosphamide or TBI and cyclophosphamide or other myeloablative regimen approved by the Clinical Study Chair. (Regimens containing ATG are not allowed.)
    4. Have an HLA-identical sibling donor
    5. Meet the transplant centre's criteria for myeloablative allogeneic transplantation*
    6. Have an ECOG performance status of 0, 1 or 2
    7. Have given signed informed consent

Donor must

  1. Be 18 years of age or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.)
  2. Be able to undergo general anesthesia and BM harvest or peripheral blood collection as per assessment by a transplant physician. (If an anesthetist assesses a donor after randomization and determines the donor should not undergo general anesthesia, then the donor and recipient will be withdrawn from the study.)
  3. Be a sibling of the recipient
  4. Be a 6/6 HLA match of the recipient. HLA typing is by serologic or DNA methodology for A and B and by DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
  5. Have given signed informed consent

Exclusion Criteria

Recipient

1. The recipient is HIV antibody positive

Donor

  1. The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection
  2. The donor is pregnant or breastfeeding at the time of progenitor cell collection
  3. The donor has a history of malignant disease within the last 5 years or current malignancy other than non-melanomatous in situ skin carcinoma or cervical carcinoma in situ
  4. The donor is HIV antibody positive
  5. The donor has a known sensitivity to E. coli-derived products
  6. The donor and recipient are identical twins
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530581


Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Mahmoud Al Jurf, MD King Faisal Specialist Hospital & Research Center
  More Information

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01530581     History of Changes
Other Study ID Numbers: 2081-076
First Submitted: January 23, 2012
First Posted: February 10, 2012
Last Update Posted: January 5, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Neoplasms