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A Phase 1b Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

A Phase 1b Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia


Inclusion Criteria:



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

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

- 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

- Contraindication to chemotherapy as first-line therapy due to patient age,
comorbidity or patient preference

- Age >/= to 18 years

- ECOG performance status of
- Life expectancy > 6 months in opinion of Investigator

- Serum creatinine, total bilirubin, ALT/SGPT
- ANC >/= 800/mm3

- Platelets >/= 30,000/mm3

Exclusion Criteria:

- For Cohorts 1 and 3 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR)

Outcome Description:

ORR by the 2008 International Workshop on CLL (IWCLL) criteria

Outcome Time Frame:

any time point during the study up to 18 months

Safety Issue:

No

Principal Investigator

Scott C. Stromatt, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Emergent Product Development Seattle LLC

Authority:

United States: Food and Drug Administration

Study ID:

16009

NCT ID:

NCT01644253

Start Date:

September 2012

Completion Date:

June 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • chronic lymphocytic leukemia
  • CLL
  • previously untreated chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

For additional information regarding sites for this trial call (919) 465-4648 Augusta, Georgia  30912
For additional information regarding sites for this trial call (919) 465-4648 Cleveland, Ohio  44195
For additional information regarding sites for this trial call (919) 465-4648 Seattle, Washington  98109
For additional information regarding sites for this trial call (919) 465-4648 Houston, Texas  77030