Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Phase 1b, Escalating Dose Study of AVL-292, a Bruton's Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
1 other identifier
interventional
113
1 country
13
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2011
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedStudy Start
First participant enrolled
July 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2015
CompletedNovember 8, 2019
November 1, 2019
3.9 years
May 10, 2011
November 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, tolerability,and dose limiting toxicities will be determined using AEs,PE,ophthalmologic examinations,clinical laboratory tests,vital signs, ECGs and echocardiograms/MUGA scans.
with in the first 28 days after initiation of once daily oral dosing
Secondary Outcomes (4)
Establish recommended Phase 2 dose, after completing dose escalation in Part 1 and evaluating accumulated safety,PK,and PD data from the dose escalation phase (Part1)
Completion of Part 1 dose escalation phase of study
Evaluate the Pharmacokinetic parameters of AVL-292
First 28 days of dosing
Evaluate the Pharmacodynamics of AVL-292 by measurement of free Btk
First 28 days of dosing
Characterize preliminary anti-tumor efficacy of AVL-292 in relapsed and/or refractory B-NHL, CLL and WM
After completion of 28 day cycle of treatment
Study Arms (1)
AVL-292
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Women and men ≥18 years of age
- 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
You may not qualify if:
- Prior allogeneic bone marrow transplant
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
- The Leukemia and Lymphoma Societycollaborator
Study Sites (13)
Clearview Cancer Institute Oncology Specialties, P.C
Huntsville, Alabama, 35805, United States
University of Arizona SPORE
Tucson, Arizona, 85719, United States
University of California San Diego
La Jolla, California, 92093-0960, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Northwestern University
Chicago, Illinois, 60611, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Mount Sinai School of Medicine and Mount Sinai Graduate School of Biological Sciences
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas Health Sciences Center
San Antonio, Texas, 78229, United States
US Oncology
The Woodlands, Texas, 77380, United States
Related Publications (1)
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.
PMID: 27471698BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
July 18, 2011
Primary Completion
June 26, 2015
Study Completion
June 26, 2015
Last Updated
November 8, 2019
Record last verified: 2019-11