Chronic Myeloid LeukemiaPhase 2NCT00516152
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
A Phase 2 study testing Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF in people with Chronic Myeloid Leukemia and Acute Myelogenous Leukemia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. Read more about this study
- Who is it for?
- Ages 15 to 61 years
- Conditions the study is for
- Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia
- What is being tested?
- Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 2007
- Phase
- Phase 2
- 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 15 to 61 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- No fully or single-antigen mismatched sibling donor is available to donate stem cells.
- Age >15 and <61
- ECOG PS < or equal to 2
- Adequate renal function with serum creatinine <2.0 mg/dl
- Pulmonary diffusing capacity >40% of predicted
- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
Show all 10Show fewer
- No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
- Negative serology for the human immunodeficiency virus (HIV)
- Available HLA-matched donor (see HLA compatibility requirements below)
- Signed informed consent from the recipient
Who cannot join
- Ongoing active infection
- Pregnancy and/or nursing
- Active, uncontrolled CNS leukemia
- Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
- Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.
- Conditions
- Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia, Acute Lymphocytic Leukemia, Severe Aplastic Anemia, Non-Hodgkin's Lymphoma
- Being tested
- Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
- Keywords
- Matched Unrelated Donor, Stem Cell Transplantation, Busulfan, fludarabine, Hematopoietic Disorder
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Aplastic, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSFDrug
Day Preparative Regimen for GVHD Prophylaxis
- 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 3 Fludarabine 30 mg/m(2)IV
- 2 REST Tacrolimus 0.01 mg/kg CIVI
- 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
- 1 Methotrexate 5mg/m(2)IV
- 3 Methotrexate 5mg/m(2)IV
- 6 Methotrexate 5mg/m(2)IV
- 7 G-CSF 5mcg/kg SQ daily
- 11 Methotrexate 5mg/m(2)IV
- 90 Evaluate Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startNov 2002
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Thomas G. Martin, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516152
- Sponsor's protocol ID
- UC-2214
- Status last verified
- Jan 2009
- First submitted
- 13 Aug 2007
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00516152
- Acronym / sponsor ID
- UC-2214
- Conditions
- Chronic Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplasia, Acute Lymphocytic Leukemia, Severe Aplastic Anemia, Non-Hodgkin's Lymphoma
- Keywords
- Matched Unrelated Donor, Stem Cell Transplantation, Busulfan, fludarabine, Hematopoietic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Aug 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.
The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- No fully or single-antigen mismatched sibling donor is available to donate stem cells.
- Age >15 and <61
- ECOG PS < or equal to 2
- Adequate renal function with serum creatinine <2.0 mg/dl
- Pulmonary diffusing capacity >40% of predicted
Key exclusion criteria (5 listed)
- Ongoing active infection
- Pregnancy and/or nursing
- Active, uncontrolled CNS leukemia
- Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
- Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.
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 |
|---|---|---|
| Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSFDay Preparative Regimen for GVHD Prophylaxis * 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 3 Fludarabine 30 mg/m(2)IV * 2 REST Tacrolimus 0.01 mg/kg CIVI * 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion * 1 Methotrexate 5mg/m(2)IV * 3 Methotrexate 5mg/m(2)IV * 6 Methotrexate 5mg/m(2)IV * 7 G-CSF 5mcg/kg SQ daily * 11 Methotrexate 5mg/m(2)IV * 90 Evaluate Response | 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 26 Jan 2009.
- UCSF Cancer Center Home PageLink provided by the sponsor.
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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.
Thomas G. Martin, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF in people with Chronic Myeloid Leukemia and Acute Myelogenous Leukemia, run by University of California, San Francisco 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 10 inclusion and 5 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 26 Jan 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 26 Jan 2009.