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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 Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
B Cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia

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Trial Information

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 Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability,and dose limiting toxicities will be determined using AEs,PE,ophthalmologic examinations,clinical laboratory tests,vital signs, ECGs and echocardiograms/MUGA scans.

Outcome Time Frame:

with in the first 28 days after initiation of once daily oral dosing

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AVL-292-003

NCT ID:

NCT01351935

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • B Cell Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Waldenström Macroglobulinemia
  • non-hodgkin's lymphoma
  • lymphoma
  • leukemia
  • chronic lymphocytic leukemia
  • b-cell malignancies
  • Btk inhibitor
  • Phase 1b
  • Avila Therapeutics
  • Waldenstrom Macroglobulinemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell

Name

Location

University of Rochester Medical CenterRochester, New York  14642
Mayo ClinicJacksonville, Florida  32224
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Northwestern UniversityChicago, Illinois  60611
Cleveland ClinicCleveland, Ohio  44195
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Clearview Cancer InstituteHuntsville, Alabama  35805
Horizon Oncology CenterLafayette, Indiana  47905
University of Texas Health Science Center, San AntonioSan Antonio, Texas  78229
University of Arizona (SPORE)Tucson, Arizona  85719
Mount Sinai School of Medicine & Mount Sinai Graduate School of biological SciencesNew York, New York  10029
US Oncology Research: Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477