Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614042
• Other study ID #: 16007
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2008
• Last updated: June 26, 2017
• Start date: January 2008
• Est. completion date: March 2012

Study information

• Verified date: June 2017
• Source: Aptevo Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma (NHL)

Intervention

Drug:
• TRU-016 (anti-CD37 protein therapeutic)
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly

Locations

Country	Name	City	State
United States	For additional information regarding sites for this trial call 919-319-9374	Augusta	Georgia
United States	For additional information regarding sites for this trial call 919-319-9374	Birmingham	Alabama
United States	For additional information regarding sites for this trial call 919-319-9374	Boston	Massachusetts
United States	For additional information regarding sites for this trial call 919-319-9374	Durham	North Carolina
United States	For additional information regarding sites for this trial call 919-319-9374	Las Vegas	Nevada
United States	For additional information regarding sites for this trial call 919-319-9374	Portland	Oregon
United States	For additional information regarding sites for this trial call 919-319-9374	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Aptevo Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL		4 weeks after treatment
Secondary	Preliminary indication of response as defined by NCI 1996 criteria		3 months after treatment