LeukemiaPhase 1NCT00345826
Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
A Phase 1 study testing dasatinib in people with Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jul 2010
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following hematologic malignancies:
- Chronic phase chronic myelogenous leukemia (CML)
- In complete hematologic response after treatment on protocol UCLA-0303035, as indicated by the following criteria:
- WBC ≤ upper limit of normal (ULN)
- Platelet count < 450,000/mm^3
- No blasts or promyelocytes in peripheral blood
- Less than 5% myelocytes plus metamyelocytes in peripheral blood
- Peripheral blood basophils ≤ ULN
- No extramedullary involvement (including no hepatomegaly or splenomegaly)
- Response lasting ≥ 4 weeks after first documentation
- Accelerated or blastic phase CML or acute lymphoblastic leukemia
- In major hematologic response* after treatment on protocol UCLA-0303035, defined as 1 of the following:
- In complete hematologic response*, as indicated by the following criteria:
- WBC ≤ ULN
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- No blasts or promyelocytes in peripheral blood
- Bone marrow blasts ≤ 5%
- Less than 5% myelocytes plus metamyelocytes in peripheral blood
- Peripheral blood basophils ≤ ULN
- No extramedullary involvement (including no hepatomegaly or splenomegaly)
- No evidence of leukemia, as indicated by the following criteria:
- WBC ≤ ULN
- No blasts or promyelocytes in the peripheral blood
- Bone marrow blasts ≤ 5%
- Less than 5% myelocytes plus metamyelocytes in peripheral blood
- Peripheral blood basophils ≤ ULN
- No extramedullary involvement (including no hepatomegaly or splenomegaly)
- Absolute neutrophil count ≥ 500/mm^3 and < 1,000/mm^3 AND platelet count ≥ 20,000/mm^3 and < 100,000/mm^3
- In minor hematologic response* after treatment on protocol UCLA-0303035, as indicated by the following criteria:
- Less than 15% in bone marrow and < 15% in peripheral blood
- Less than 30% blasts plus promyelocytes in bone marrow and < 30% blasts plus promyelocytes in peripheral blood
- Less than 20% basophils in peripheral blood
- No extramedullary disease other than spleen and liver NOTE: *Response confirmed after ≥ 4 weeks allowed provided there is no concurrent anagrelide or hydroxyurea during this time
- Philadelphia chromosome-positive (Ph+) disease
- Resistant or intolerant to prior imatinib mesylate
- Received and benefitted from ≥ 3 months of prior therapy with dasatinib on protocol UCLA-0303035
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 weeks after completion of study treatment
- No serious uncontrolled medical disorder
- No active infection that would preclude study participation
- No uncontrolled angina within the past 3 months
- No diagnosed or suspected congenital long QT syndrome
- No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- QTc ≤ 450 msec on electrocardiogram
- No uncontrolled hypertension
- No dementia or altered mental status the would prohibit the understanding or rendering of informed consent
- No history of the following significant bleeding disorders unrelated to CML:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder in the past year (e.g., acquired antifactor VIII antibodies)
- Not involuntarily incarcerated for either psychiatric or physical (e.g., infectious disease) illness
- No patients who are imprisoned
- No clinical adverse event, laboratory abnormality, or intercurrent illness that may preclude study treatment, in the opinion of the investigator
- Bilirubin < 1.5 mg/dL
- ALT and AST < 2 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent use of the following drugs that may confer risk of torsades de pointes:
- Quinidine
- Procainamide
- Disopyramide
- Amiodarone
- Sotalol
- Ibutilide
- Dofetilide
- Erythromycin
- Clarithromycin
- Chlorpromazine
- Haloperidol
- Mesoridazine
- Thioridazine
- Pimozide
- Cisapride
- Bepridil
- Droperidol
- Methadone
- Arsenic
- Chloroquine
- Domperidone
- Halofantrine
- Levomethadyl
- Pentamidine
- Sparfloxacin
- Lidoflazine
- No other concurrent treatment for CML except for hydroxyurea for a 2-week duration
- No concurrent medications that inhibit platelet function (e.g., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, or any nonsteroidal anti-inflammatory drug)* except for hydroxyurea or anagrelide
- No concurrent anticoagulants (e.g., warfarin or heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin]) except as prophylaxis for catheter thrombosis and/or heparin flushes for IV lines* NOTE: *Allowed if received previously on UCLA-0303035
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate.
Secondary
- Describe any hematologic or cytogenetic response in patients treated with this drug.
- Determine the duration of hematologic and cytogenetic response in patients using this drug during trial UCLA-0303035.
- Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.
Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- dasatinib
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Not described Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety and tolerability
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Sawyers, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345826
- Sponsor's protocol ID
- CDR0000480396
- Other IDs
- UCLA-0509010-01, BMS-CA180039
- Status last verified
- Jan 2013
- First submitted
- 28 Jun 2006
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Talpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, Cortes J, O'Brien S, Nicaise C, Bleickardt E, Blackwood-Chirchir MA, Iyer V, Chen TT, Huang F, Decillis AP, Sawyers CL. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. doi: 10.1056/NEJMoa055229.
PubMed 16775234
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
- ClinicalTrials.gov ID
- NCT00345826
- Acronym / sponsor ID
- CDR0000480396
- Conditions
- Leukemia
- Keywords
- accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Jul 2010 (actual)
- First posted
- 29 Jun 2006 (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.
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
Primary
- Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate.
Secondary
- Describe any hematologic or cytogenetic response in patients treated with this drug.
- Determine the duration of hematologic and cytogenetic response in patients using this drug during trial UCLA-0303035.
- Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.
Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| dasatinib | Drug | Dasatinib |
Primary outcome
Long term safety and tolerability
Time frame: 5 years
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 8 Jan 2013.
- Results publication: PubMed 16775234Talpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, Cortes J, O'Brien S, Nicaise C, Bleickardt E, Blackwood-Chirchir MA, Iyer V, Chen TT, Huang F, Decillis AP, Sawyers CL. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. doi: 10.1056/NEJMoa055229.
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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.
Charles Sawyers, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dasatinib in people with Leukemia, run by Jonsson Comprehensive Cancer Center 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 8 Jan 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Long term safety and tolerability (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345826, which also lists 1 linked publication.
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 8 Jan 2013.