Hematological NeoplasmsNCT00582894
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
A study testing Busulfex, Fludarabine, ALemtuzumab in people with Hematological Neoplasms and Hematopoietic Stem Cell Transplantation, run by University of Oklahoma at 1 site in United States.
Trial summary
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Neoplasms, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Busulfex, Fludarabine, ALemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status 0-2
- Ejection fraction > 30%
- AST/ALT and bilirubin not > 4 times normal
- Creatinine clearance greater than 70 ml/min.
- FEV1 greater than 1.0 and diffusion capacity greater than 40%
- Age 18-75 years
- Patients must be at high risk for conventional regimen related toxicity
- Malignant hematologic disease that would otherwise be considered treatable with ASCT
Who cannot join
- Does not meet the above Inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
Read the detailed description
Primary Endpoints:
- Engraftment of donor cells
- Regimen related toxicities
Secondary Endpoints:
- Disease-free survival
- Overall survival
- Being tested
- Busulfex, Fludarabine, ALemtuzumab
- Keywords
- Allogenic stem cell transplant, Hematologic diseases
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfex, Fludarabine, ALemtuzumabDrug
Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 Receives: Drug: Busulfex, Fludarabine, ALemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Transplant Related Mortality (TRM)
Measured: At Day 100 post trans-plant
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Measured: At time of study termination
Secondary outcomes (2)
Number of Participants Relapse-Free
Measured: 100 days post-transplant
Number of Participants Overall Survival as a Function of Time.
Measured: 100 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematological NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- George Selby, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582894
- Sponsor's protocol ID
- Reduced-Intensity
- Other IDs
- IRB #11835
- Status last verified
- Mar 2011
- First submitted
- 19 Dec 2007
- Last updated
- 22 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
- ClinicalTrials.gov ID
- NCT00582894
- Acronym / sponsor ID
- Reduced-Intensity
- Keywords
- Allogenic stem cell transplant, Hematologic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 22 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
Detailed description
Primary Endpoints:
- Engraftment of donor cells
- Regimen related toxicities
Secondary Endpoints:
- Disease-free survival
- Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Busulfex, Fludarabine, ALemtuzumabPreparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Performance status 0-2
- Ejection fraction > 30%
- AST/ALT and bilirubin not > 4 times normal
- Creatinine clearance greater than 70 ml/min.
- FEV1 greater than 1.0 and diffusion capacity greater than 40%
Key exclusion criteria (1 listed)
- Does not meet the above Inclusion criteria
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 |
|---|---|---|
| Busulfex, Fludarabine, ALemtuzumabBusulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1 | Drug | A |
Primary outcome
Number of Participants Experiencing Transplant Related Mortality (TRM)
Time frame: At Day 100 post trans-plant
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Time frame: At time of study termination
2 secondary outcomes
Number of Participants Relapse-Free
Time frame: 100 days post-transplant
Number of Participants Overall Survival as a Function of Time.
Time frame: 100 days post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Selby, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Busulfex, Fludarabine, ALemtuzumab in people with Hematological Neoplasms and Hematopoietic Stem Cell Transplantation, run by University of Oklahoma at 1 site in United States.
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 8 inclusion and 1 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 22 Apr 2011. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Transplant Related Mortality (TRM) (time frame: At Day 100 post trans-plant). The study lists 2 primary outcomes in all. 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 22 Apr 2011.