Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
NCT ID: NCT01351935
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
113 participants
INTERVENTIONAL
2011-07-18
2015-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AVL-292
AVL-292
125 mg to 625 mg orally, once a day, for 28 days (28 days equals 1 cycle). Number of cycles: until progression or unacceptable toxicity develops
Interventions
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AVL-292
125 mg to 625 mg orally, once a day, for 28 days (28 days equals 1 cycle). Number of cycles: until progression or unacceptable toxicity develops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight ≥50 kg.
* Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop)
* Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.
* Eastern Cooperative Oncology Group performance status of ≤ 2 and a life expectancy of at least 3 months.
* Ability to swallow oral capsules without difficulty
* Has recovered from adverse toxic effects of prior therapies
* Meet the following clinical laboratory requirements:
* Creatinine ≤ 1.5 × upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN
* AST and ALT ≤ 3 × ULN
* Platelet count ≥ 50,000/µL (non-hodgkin \& Waldenstrom's)
* Platelet count ≥ 30,000/µL (chronic lymphocytic leukemia)
* Absolute Neutrophil count ≥ 1000/µL
Exclusion Criteria
* Autologous stem cell transplant within 3 months of screening
* Active central nervous system involvement
* Subjects with autoimmune hemolytic anemia or immune thrombocytopenia
* Prior treatment with a Btk inhibitor
* Active uncontrolled infection
* History of malabsorption
* Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.
* History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months
* History of another currently active cancer
* History of major surgery within 4 weeks or minor surgery within 1 week
* Other medical or psychiatric illness or organ dysfunction
* HIV positive
* Positive for Hepatitis B surface antigen or Hepatitis C-virus
18 Years
ALL
No
Sponsors
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The Leukemia and Lymphoma Society
OTHER
Celgene
INDUSTRY
Responsible Party
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Locations
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Clearview Cancer Institute Oncology Specialties, P.C
Huntsville, Alabama, United States
University of Arizona SPORE
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mount Sinai School of Medicine and Mount Sinai Graduate School of Biological Sciences
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
US Oncology
The Woodlands, Texas, United States
Countries
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References
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Arnason JE, Brown JR. B cell receptor pathway in chronic lymphocytic leukemia: specific role of CC-292. Immunotargets Ther. 2014 Jan 24;3:29-38. doi: 10.2147/ITT.S37419. eCollection 2014.
Related Links
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Leukemia \& Lymphoma Society
Other Identifiers
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AVL-292-003
Identifier Type: -
Identifier Source: org_study_id
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