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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

Study groups in NCT00345826
Study groupRoleWhat they receive
DasatinibExperimentalNot described
Receives: Drug: dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted29 Jun 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJul 2010

Resources

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)
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

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.

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