Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab, Obinutuzumab, Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia

Protocol: OSU-12095

Full Title

A Phase Ib, Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination with Rituximab, in Combination with Obinutuzumab, in Combination with Rituximab and Idelalisib, or in Combination with Ibrutinib in Patients with Chronic Lymphocytic Leukemia and in Combination with Bendamustine in Patients with Peripheral T-cell Lymphoma (PTCL)


The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when

administered in combination with rituximab or obinutuzumab, in combination with idelalisib

and rituximab, or in combination with ibrutinib in patients with chronic lymphocytic

leukemia (CLL).

Are you eligible?

Inclusion Criteria:

Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk


No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments.

For Cohort 5, patients must have failed to respond or relapsed after 1 or more

treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at

least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected.

For Cohort 7, patients who are receiving ibrutinib with stable disease and now have

the cysteine 481 mutant clone present at levels of >1%.

At least one of the following criteria for active disease requiring treatment:

progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to

bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a

2-month period or an unanticipated doubling time of less than 6 months

For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to

patient age, comorbidity or patient preference

Age >/= to 18 years

ECOG performance status of </= 2

Life expectancy > 6 months in opinion of Investigator

Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal

ANC >/= 800/mm3

Platelets >/= 30,000/mm3

Exclusion Criteria:

For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab,

ofatumumab or any other chemotherapeutic agent for CLL

Has received an investigational therapy within 30 days of first dose of study drug

Previous or concurrent additional malignancy

Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone

marrow transplant, active autoimmune disease

Positive serology for HIV or hepatitis C

Hepatitis B surface antigen or hepatitis B core antibody positive

Pregnant or breastfeeding

Known current drug or alcohol abuse