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
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.
- 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