Clinical trial NCT00614042: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia (CLL)
Non-Hodgkin's Lymphoma (NHL)
Keywords: CLL
NHL
TRU-016
chronic lymphocytic leukemia
non-Hodgkin's lymphoma
Lead sponsor: Aptevo Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: Preliminary indication of response as defined by NCI 1996 criteria
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Alabama
city: Augusta
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Georgia
city: Boston
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Massachusetts
city: Las Vegas
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Nevada
city: Durham
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: North Carolina
city: Portland
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Oregon
city: Seattle
country: United States
facility: For additional information regarding sites for this trial call 919-319-9374
state: Washington
Study officials:
affiliation: Aptevo Therapeutics
name: Scott Stromatt, MD
role: STUDY_DIRECTOR
References:
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.
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.