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Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (START rollover)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982488
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : January 22, 2016
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Dasatinib Drug: Imatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis
Study Start Date : October 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID).
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase

Imatinib, 400 mg BID, Chronic phase
Participants with chronic phase disease received 400 mg of imatinib twice BID.
Drug: Imatinib
Imatinib was supplied as 100- and 400-mg tablets.
Other Name: Gleevec/Glivec

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Drug: Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Other Names:
  • BMS-354825
  • Sprycel
  • Src Kinase




Primary Outcome Measures :
  1. Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest [ Time Frame: Day 1 of treatment through a maximum of 82 months + 30 days ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • Signed written informed consent
  • Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
  • Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
  • Men and women, ages 18 and older

Key Exclusion Criteria

  • A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
  • Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982488


Locations
Show Show 72 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00982488    
Other Study ID Numbers: CA180-188
2007-003624-37
First Posted: September 23, 2009    Key Record Dates
Results First Posted: January 22, 2016
Last Update Posted: January 22, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action