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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emergent Product Development Seattle LLC
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT01644253
First received: July 12, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 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
Biological: TRU-016 20 mg/kg + Obinutuzumab
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 or in Combination With Obinutuzumab 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: 68
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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
Experimental: Cohort 4 - Previously Untreated CLL
20 mg/kg TRU-016 20 + Obinutuzumab
Biological: TRU-016 20 mg/kg + Obinutuzumab

TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months

Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months

Other Name: Gazyva

  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, 3 and 4. 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644253

Contacts
Contact: Megan Henry (919) 465-4648

Locations
United States, Georgia
For additional information regarding sites for this trial call (919) 465-4648 Recruiting
Augusta, Georgia, United States, 30912
Contact: Megan Henry    919-465-4648      
United States, Ohio
For additional information regarding sites for this trial call (919) 465-4648 Recruiting
Columbus, Ohio, United States, 43210
Contact: Megan Henry    919-465-4648      
United States, Texas
For additional information regarding sites for this trial call (919) 465-4648 Recruiting
Houston, Texas, United States, 77030
Contact: Megan Henry    919-465-4648      
United States, Washington
For additional information regarding sites for this trial call (919) 465-4648 Active, not recruiting
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: June 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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Obinutuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014