Transplantation for Hematologic MalignanciesPhase 3NCT01530581
Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation
A Phase 3 study testing G-PB Transplant and G-BM Transplant in people with Transplantation for Hematologic Malignancies, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Transplantation for Hematologic Malignancies
- What is being tested?
- G-PB Transplant and G-BM Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2008to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recipient must
- Be between the ages of 16 and 65 years old
- 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)
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- 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
- 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.)
- Have an HLA-identical sibling donor
- Meet the transplant centre's criteria for myeloablative allogeneic transplantation*
- Have an ECOG performance status of 0, 1 or 2
- Have given signed informed consent
- Donor must
- Be 18 years of age or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.)
- 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.)
- Be a sibling of the recipient
- 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)
- Have given signed informed consent
Who cannot join
- Recipient
- 1. The recipient is HIV antibody positive
- Donor
- The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection
- The donor is pregnant or breastfeeding at the time of progenitor cell collection
- 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
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- The donor is HIV antibody positive
- The donor has a known sensitivity to E. coli-derived products
- The donor and recipient are identical twins
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
About this study
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
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.
- Being tested
- G-PB Transplant, G-BM Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-PB TransplantProcedure or surgery
G-PB Transplant
G-BM TransplantProcedure or surgery
G-BM Transplant
| Study group | Role | What they receive |
|---|---|---|
| G-BM Transplant | Experimental | Not described Receives: Procedure: G-BM Transplant |
| G-PB Transplant | Other | G-PB Transplant Receives: Procedure: G-PB Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startNov 2008
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Al Jurf, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530581
- Sponsor's protocol ID
- 2081-076
- Status last verified
- Aug 2018
- First submitted
- 23 Jan 2012
- Last updated
- 10 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01530581
- Acronym / sponsor ID
- 2081-076
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-BM Transplant | Experimental | Procedure: G-BM Transplant |
| G-PB Transplant | Other | Procedure: G-PB TransplantG-PB Transplant |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Recipient must
- Donor must
- Be 18 years of age or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.)
- 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.)
- Be a sibling of the recipient
Key exclusion criteria (9 listed)
- Recipient
- 1. The recipient is HIV antibody positive
- Donor
- The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection
- The donor is pregnant or breastfeeding at the time of progenitor cell collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-PB TransplantG-PB Transplant | Procedure or surgery | G-PB Transplant |
| G-BM TransplantG-BM Transplant | Procedure or surgery | G-BM Transplant |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Al Jurf, MD principal investigator
King Faisal Specialist Hospital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing G-PB Transplant and G-BM Transplant in people with Transplantation for Hematologic Malignancies, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.