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 |
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).
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.
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
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
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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New York, New York 10029
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