Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab in Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT01644253
First received: July 12, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when administered in combination with rituximab in patients with chronic lymphocytic leukemia (CLL).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Biological: 20 mg/kg TRU-016 + Rituximab
Biological: 10 mg/kg TRU-016 + Rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: No ]
    ORR by the 2008 International Workshop on CLL (IWCLL) criteria


Secondary Outcome Measures:
  • Safety [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: Yes ]
    The incidence and severity of adverse events, and changes from baseline in laboratory parameters, vital signs, and physical examination will be determined.

  • ORR [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: No ]
    ORR by 1996 NCI Working Group Criteria

  • Progression-free survival (PFS) [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: No ]
  • Duration of response (DOR) [ Time Frame: any time point during the study up to 18 months ] [ Designated as safety issue: No ]
  • Resolution of disease-related symptoms [ Time Frame: Any time point during the study up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 - Previously Untreated CLL
20 mg/kg TRU-016 + Rituximab
Biological: 20 mg/kg TRU-016 + Rituximab

TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses

Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses

Other Name: Rituxan
Experimental: Cohort 2 - Relapsed CLL
20 mg/kg TRU-016 + Rituximab
Biological: 20 mg/kg TRU-016 + Rituximab

TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses

Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses

Other Name: Rituxan
Experimental: Cohort 3 - Previously Untreated CLL
10 mg/kg TRU-016 + Rituximab
Biological: 10 mg/kg TRU-016 + Rituximab

TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses

Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule

Other Name: Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644253

Locations
United States, Georgia
For additional information regarding sites for this trial call (919) 465-4648
Augusta, Georgia, United States, 30912
United States, Ohio
For additional information regarding sites for this trial call (919) 465-4648
Columbus, Ohio, United States, 43210
United States, Texas
For additional information regarding sites for this trial call (919) 465-4648
Houston, Texas, United States, 77030
United States, Washington
For additional information regarding sites for this trial call (919) 465-4648
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Emergent Product Development Seattle LLC
Investigators
Study Director: Scott C. Stromatt, M.D. Emergent Product Development Seattle LLC
  More Information

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT01644253     History of Changes
Other Study ID Numbers: 16009
Study First Received: July 12, 2012
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent Product Development Seattle LLC:
chronic lymphocytic leukemia
CLL
previously untreated chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014