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

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

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.

Study Overview

• Status: Completed
• Conditions: Transplantation for Hematologic Malignancies
• Intervention / Treatment: Procedure: G-BM Transplant; Procedure: G-PB Transplant

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G-BM Transplant	Procedure: G-BM Transplant; G-BM Transplant
Other: G-PB Transplant	Procedure: G-PB Transplant; G-PB Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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.	2 years

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Mahmoud Al Jurf, MD, King Faisal Specialist Hospital & Research Center

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 10, 2012

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 2081-076