Back to resultsPhase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
Primary Purpose
Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRU-016 (anti-CD37 protein therapeutic)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b)
- Previous treatment with at least one fludarabine-containing regimen
Demonstrate at least one of the following criteria for active disease requiring treatment:
- a)progressive splenomegaly and/or lymphadenopathy;
- b)anemia or thrombocytopenia due to bone marrow involvement;
- c)unintentional weight loss >10% over preceding 6-month period;
- d) NCI Grade 2 or 3 fatigue;
- e) fevers >100.5 F or night sweats for > 2 weeks without infection;
- f) progressive lymphocytosis with increase of >50% over a 2-month period or anticipated doubling time of < 6 months.
- ECOG performance status </= 2
- SGOT, SGPT </= 2.0 x upper limit of normal
- ANC >/= 500/uL
- Platelets >/= 30,000/uL
- Discontinued previous anticancer or investigational therapy for at least 30 days
Exclusion Criteria:
- Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks
- ANC </= 500/uL
- Platelets </= 30,000/mm3
- Previous or concurrent additional malignancy
- Significant concurrent medical diseases or conditions
- Hepatitis B surface antigen or hepatitis B core antibody positive
- Pregnant or breastfeeding
Sites / Locations
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
- For additional information regarding sites for this trial call 919-319-9374
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Dose escalation and expansion cohorts
Outcomes
Primary Outcome Measures
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
Secondary Outcome Measures
Preliminary indication of response as defined by NCI 1996 criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00614042
Brief Title
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
Official Title
A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptevo Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.
Detailed Description
This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
Keywords
CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose escalation and expansion cohorts
Intervention Type
Drug
Intervention Name(s)
TRU-016 (anti-CD37 protein therapeutic)
Intervention Description
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
Primary Outcome Measure Information:
Title
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
Preliminary indication of response as defined by NCI 1996 criteria
Time Frame
3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b)
Previous treatment with at least one fludarabine-containing regimen
Demonstrate at least one of the following criteria for active disease requiring treatment:
a)progressive splenomegaly and/or lymphadenopathy;
b)anemia or thrombocytopenia due to bone marrow involvement;
c)unintentional weight loss >10% over preceding 6-month period;
d) NCI Grade 2 or 3 fatigue;
e) fevers >100.5 F or night sweats for > 2 weeks without infection;
f) progressive lymphocytosis with increase of >50% over a 2-month period or anticipated doubling time of < 6 months.
ECOG performance status </= 2
SGOT, SGPT </= 2.0 x upper limit of normal
ANC >/= 500/uL
Platelets >/= 30,000/uL
Discontinued previous anticancer or investigational therapy for at least 30 days
Exclusion Criteria:
Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks
ANC </= 500/uL
Platelets </= 30,000/mm3
Previous or concurrent additional malignancy
Significant concurrent medical diseases or conditions
Hepatitis B surface antigen or hepatitis B core antibody positive
Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Stromatt, MD
Organizational Affiliation
Aptevo Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
For additional information regarding sites for this trial call 919-319-9374
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25146490
Citation
Pagel JM, Spurgeon SE, Byrd JC, Awan FT, Flinn IW, Lanasa MC, Eisenfeld AJ, Stromatt SC, Gopal AK. Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR() therapeutic protein, for relapsed or refractory NHL patients. Br J Haematol. 2015 Jan;168(1):38-45. doi: 10.1111/bjh.13099. Epub 2014 Aug 22.
Results Reference
result
PubMed Identifier
24381226
Citation
Byrd JC, Pagel JM, Awan FT, Forero A, Flinn IW, Deauna-Limayo DP, Spurgeon SE, Andritsos LA, Gopal AK, Leonard JP, Eisenfeld AJ, Bannink JE, Stromatt SC, Furman RR. A phase 1 study evaluating the safety and tolerability of otlertuzumab, an anti-CD37 mono-specific ADAPTIR therapeutic protein in chronic lymphocytic leukemia. Blood. 2014 Feb 27;123(9):1302-8. doi: 10.1182/blood-2013-07-512137. Epub 2013 Dec 31.
Results Reference
derived
Learn more about this trial
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
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