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

Sponsor

Aptevo Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00614042

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

13.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL) Non-Hodgkin's Lymphoma (NHL)	Drug: TRU-016 (anti-CD37 protein therapeutic)	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose escalation and expansion cohorts	Drug: TRU-016 (anti-CD37 protein therapeutic) TRU-016 administered via IV infusion weekly for 8 weeks and then monthly

Arm

Intervention/Treatment

Experimental: 1

Dose escalation and expansion cohorts

Drug: TRU-016 (anti-CD37 protein therapeutic)

TRU-016 administered via IV infusion weekly for 8 weeks and then monthly

Outcome Measures

Primary Outcome Measures

Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL [4 weeks after treatment]

Secondary Outcome Measures

Preliminary indication of response as defined by NCI 1996 criteria [3 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
1. NCI Grade 2 or 3 fatigue;
1. fevers >100.5 F or night sweats for > 2 weeks without infection;
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding sites for this trial call 919-319-9374	Birmingham	Alabama	United States	35294
2	For additional information regarding sites for this trial call 919-319-9374	Augusta	Georgia	United States	30912
3	For additional information regarding sites for this trial call 919-319-9374	Boston	Massachusetts	United States	02111
4	For additional information regarding sites for this trial call 919-319-9374	Las Vegas	Nevada	United States	89135
5	For additional information regarding sites for this trial call 919-319-9374	Durham	North Carolina	United States	27710
6	For additional information regarding sites for this trial call 919-319-9374	Portland	Oregon	United States	97239
7	For additional information regarding sites for this trial call 919-319-9374	Seattle	Washington	United States	98109