Leukemia, Monocytic, AcuteNCT00531583
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
A study testing Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation in people with Leukemia, Monocytic, Acute, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st \& 2nd complete remission w/no HLA matched related donor Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Leukemia, Monocytic, Acute
- What is being tested?
- Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation
- How many people
- 350 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2001to Jun 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML in 1st \& 2nd complete remission w/no HLA matched related donor
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st \& 2nd complete remission w/no HLA matched related donor
- Conditions
- Leukemia, Monocytic, Acute
- Being tested
- Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation
- Keywords
- AML in 1st & 2nd complete remission w/no HLA matched related donor
- Medical subject headings
- Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantationDrug
Autologous PBSCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 2009-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startMar 2001
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Monocytic, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahad AlMohareb, Principal investigator, KFSH&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531583
- Sponsor's protocol ID
- RAC#2001-004
- Status last verified
- Jan 2016
- First submitted
- 17 Sep 2007
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
- ClinicalTrials.gov ID
- NCT00531583
- Acronym / sponsor ID
- RAC#2001-004
- Conditions
- Leukemia, Monocytic, Acute
- Keywords
- AML in 1st & 2nd complete remission w/no HLA matched related donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Sep 2007 (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.
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st \& 2nd complete remission w/no HLA matched related donor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with AML in 1st \& 2nd complete remission w/no HLA matched related donor
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantationAutologous PBSCT | Drug | – |
Primary outcome
Efficacy
Time frame: 2009-2015
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 5 Jan 2016.
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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.
Fahad AlMohareb principal investigator
KFSH&RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation in people with Leukemia, Monocytic, Acute, 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 1 inclusion and 0 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 5 Jan 2016. 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.
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: 2009-2015). 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 5 Jan 2016.