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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


Phase 3
16 Years
65 Years
Open (Enrolling)
Both
Transplantation for Hematologic Malignancies

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Trial Information

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


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then the donor and recipient will be withdrawn from the study.)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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mahmoud Al Jurf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Faisal Specialist Hospital & Research Center

Authority:

United States: Federal Government

Study ID:

2081-076

NCT ID:

NCT01530581

Start Date:

November 2008

Completion Date:

June 2014

Related Keywords:

  • Transplantation for Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms

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