Phase 1b Safety and Efficacy Study of TRU-016
Stopped early · Phase 1
Conditions studied: Chronic Lymphocytic Leukemia, Peripheral T-cell Lymphoma
In brief
The purpose of this study is to evaluate the efficacy and safety 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 CLL; and in combination with bendamustine in patients with PTCL.
Key facts
- Study ID
- NCT01644253
- Run by
- Aptevo Therapeutics
- People needed
- 87
- Starts
- 2012-09-01
- Expected to finish
- 2021-04-21
- Last updated by the study team
- 2021-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL. Cohort 8 patients must have a diagnosis of PTCL.
- 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%. For Cohort 8, have refractory or relapsed PTCL after one or more prior therapies.
- 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, Cohort 8 (PTCL): ANC >/= 1000/mm3
- Platelets >/= 30,000/mm3
You may not qualify if…
- For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL. Cohort 8: Received prior treatment with bendamustine and did not respond during treatment or relapsed less than sex months after completing treatment.
- 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
Where it is running
- Study site — Augusta, Georgia, United States
- Study site — Columbus, Ohio, United States
- Eastern Regional Medical Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Greenville Health System — Greenville, South Carolina, United States
- Study site — Houston, Texas, United States
- Swedish Cancer Institute,1221 Madison St. — Seattle, Washington, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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