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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

Study Start

First participant enrolled

January 1, 2008

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed

19 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed

Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

3.9 years

First QC Date

January 25, 2008

Last Update Submit

June 26, 2017

Conditions

Chronic Lymphocytic Leukemia (CLL)Non-Hodgkin's Lymphoma (NHL)

Keywords

CLLNHLTRU-016chronic lymphocytic leukemianon-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

1

EXPERIMENTAL

Dose escalation and expansion cohorts

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

Interventions

TRU-016 (anti-CD37 protein therapeutic)DRUG

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.