Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia



Status:Completed
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2011
End Date:June 2015

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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

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).

Bruton's tyrosine kinase (Btk) is non-receptor tyrosine kinase with restricted cellular
expression largely limited to B-lymphocytes, monocytes, and mast cells or basophils. Btk is
a critical component of the B cell receptor (BCR) signaling network and is crucial for B
cell development. Investigation has revealed that some B cell lymphomas and CLL depend on
BCR signaling, suggesting that interruption of such signaling could be a promising
therapeutic opportunity in B-NHL, CLL and WM.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
13
sites
The Woodlands, Texas 77380
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The Woodlands, TX
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Huntsville, AL
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Jacksonville, Florida 32216
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Jacksonville, FL
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Lafayette, Indiana 47905
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Lafayette, IN
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LaJolla, California 92037
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LaJolla, CA
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New York, NY
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San Antonio, TX
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Tucson, Arizona 85719
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Tucson, AZ
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