Acute DiseaseNCT00186342
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
A study testing ablative allogeneic hematopoietic cell transplantation in people with Acute Disease and Myelodysplastic Syndromes, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). Read more about this study
- Who is it for?
- Ages 51 to 60 years
- Conditions the study is for
- Acute Disease, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic
- What is being tested?
- ablative allogeneic hematopoietic cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1992to Jan 2009
- 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 51 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.
- Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
- Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
- Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).
Read the detailed description
To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.
- Conditions
- Acute Disease, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Myeloproliferative Disorders, Blood and Marrow Transplant (BMT), Myelodysplastic Syndromes (MDS)
- Being tested
- ablative allogeneic hematopoietic cell transplantation
- Medical subject headings
- Acute Disease, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myeloproliferative Disorders, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablative allogeneic hematopoietic cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CIK cell | Experimental | The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD. Receives: Procedure: ablative allogeneic hematopoietic cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerability
efficacy of therapy
Secondary outcomes (1)
compare efficacy of this treatment to historical controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 1992
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Negrin, Stanford University
- Investigators
- Robert S Negrin, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186342
- Sponsor's protocol ID
- BMT45
- Other IDs
- 75274, BMT45, NCT00186342
- Status last verified
- Dec 2012
- First submitted
- 13 Sep 2005
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
- ClinicalTrials.gov ID
- NCT00186342
- Acronym / sponsor ID
- BMT45
- Conditions
- Acute Disease, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Myeloproliferative Disorders, Blood and Marrow Transplant (BMT), Myelodysplastic Syndromes (MDS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 1992
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 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.
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).
Detailed description
To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIK cell | Experimental | Procedure: ablative allogeneic hematopoietic cell transplantationThe initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD. |
Who may qualify
- Ages
- 51 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| ablative allogeneic hematopoietic cell transplantation | Procedure or surgery | CIK cell |
Primary outcome
tolerability
efficacy of therapy
1 secondary outcome
compare efficacy of this treatment to historical controls
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 17 Dec 2012.
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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.
Robert S Negrin principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablative allogeneic hematopoietic cell transplantation in people with Acute Disease and Myelodysplastic Syndromes, run by Stanford University 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?
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 17 Dec 2012. 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?
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?
tolerability. 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 17 Dec 2012.