Peripheral Stem Cell/Marrow TransplantNCT00168168
ACB A Randomized Study of 2.5ug/kg/Day vs. 5ug/kg/Day Dose of G-CSF After High Dose Chemotherapy Followed by Autologous Peripheral Blood Stem Cell/Marrow Transplant Recipients FILE#17159
A study testing G-CSF/Filgrastim in people with Peripheral Stem Cell/Marrow Transplant, run by Alberta Health services at 1 site in Canada.
Trial summary
Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Stem Cell/Marrow Transplant
- What is being tested?
- G-CSF/Filgrastim
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Feb 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over age 18
- autologous stem cell/marrow transplant candidate in MM, lymphoma, AMG and testicular
Who cannot join
- age below 18 years
- sensitive to G-CSF
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.
- Conditions
- Peripheral Stem Cell/Marrow Transplant
- Being tested
- G-CSF/Filgrastim
- Keywords
- G-CSF, Filgrastim, Engraftment time, Autologus transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF/FilgrastimDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Stem Cell/Marrow TransplantStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Meluka Game, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168168
- Sponsor's protocol ID
- HE-10-0053
- Status last verified
- Apr 2007
- First submitted
- 14 Sep 2005
- Last updated
- 9 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACB A Randomized Study of 2.5ug/kg/Day vs. 5ug/kg/Day Dose of G-CSF After High Dose Chemotherapy Followed by Autologous Peripheral Blood Stem Cell/Marrow Transplant Recipients FILE#17159
- ClinicalTrials.gov ID
- NCT00168168
- Acronym / sponsor ID
- HE-10-0053
- Conditions
- Peripheral Stem Cell/Marrow Transplant
- Keywords
- G-CSF, Filgrastim, Engraftment time, Autologus transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over age 18
- autologous stem cell/marrow transplant candidate in MM, lymphoma, AMG and testicular
Key exclusion criteria (2 listed)
- age below 18 years
- sensitive to G-CSF
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-CSF/Filgrastim | Drug | – |
Primary outcome
Not reported in the source record.
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 9 Feb 2010.
Related trials for Peripheral Stem Cell/Marrow Transplant
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
RecruitingPhase 2
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
Severe Aplastic Anemia (SAA), Hypo-Plastic Myelodysplastic Syndrome (MDS)
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
RecruitingPhase 2
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Acute Leukemia, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease
Chronic Granulomatous Disease Transplant
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.
Meluka Game, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-CSF/Filgrastim in people with Peripheral Stem Cell/Marrow Transplant, run by Alberta Health services at 1 site in Canada.
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 2 inclusion and 2 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 9 Feb 2010. 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 Canada. 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.
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.
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 9 Feb 2010.