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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)

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Trial Information

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


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.


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
- SGOT, SGPT
- 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
- Platelets
- Previous or concurrent additional malignancy

- Significant concurrent medical diseases or conditions

- Hepatitis B surface antigen or hepatitis B core antibody positive

- Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL

Outcome Time Frame:

4 weeks after treatment

Safety Issue:

No

Principal Investigator

Scott Stromatt, MD

Investigator Role:

Study Director

Investigator Affiliation:

Emergent Product Development Seattle LLC

Authority:

United States: Food and Drug Administration

Study ID:

16007

NCT ID:

NCT00614042

Start Date:

January 2008

Completion Date:

March 2012

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Non-Hodgkin's Lymphoma (NHL)
  • CLL
  • NHL
  • TRU-016
  • chronic lymphocytic leukemia
  • non-Hodgkin's lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

For additional information regarding sites for this trial call 919-319-9374 Birmingham, Alabama  35294
For additional information regarding sites for this trial call 919-319-9374 Augusta, Georgia  30912
For additional information regarding sites for this trial call 919-319-9374 Boston, Massachusetts  02111
For additional information regarding sites for this trial call 919-319-9374 Las Vegas, Nevada  89135
For additional information regarding sites for this trial call 919-319-9374 Durham, North Carolina  27710
For additional information regarding sites for this trial call 919-319-9374 Portland, Oregon  97239
For additional information regarding sites for this trial call 919-319-9374 Seattle, Washington  98109