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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 is currently recruiting participants.
Verified February 2012 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01530581
First received: January 23, 2012
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 230
Study Start Date: November 2008
Estimated Study Completion Date: June 2014
Estimated 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
No Intervention: G-PB Transplant
G-PB Transplant
 Procedure: G-PB Transplant
G-PB Transplant

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530581

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Mahmoud Aljurf, MD     966-1-4423940     maljurf@kfshrc.edu.sa    
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Mahmoud Al Jurf, MD King Faisal Specialist Hospital & Research Center
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01530581     History of Changes
Other Study ID Numbers: 2081-076
Study First Received: January 23, 2012
Last Updated: February 9, 2012
Health Authority: United States: Federal Government
Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013