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

Completed · Phase 1

Conditions studied: B Cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia

In brief

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).

Key facts

Study ID

NCT01351935

Run by

Celgene

People needed

113

Starts

2011-07-18

Expected to finish

2015-06-26

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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