Non Hodgkin Lymphoma Clinical Trial

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

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).

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

113

Study ID:

NCT01351935

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 13 Locations for this study

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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, 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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

113

Study ID:

NCT01351935

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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