Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Emergent Product Development Seattle LLC
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00614042
First received: January 25, 2008
Last updated: November 9, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia (CLL) Non-Hodgkin's Lymphoma (NHL) |
Drug: TRU-016 (anti-CD37 protein therapeutic) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Emergent Product Development Seattle LLC:
Primary Outcome Measures:
- Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Preliminary indication of response as defined by NCI 1996 criteria [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
| Enrollment: | 96 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614042
Locations
| United States, Alabama | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Georgia | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Augusta, Georgia, United States, 30912 | |
| United States, Massachusetts | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Nevada | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, North Carolina | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Portland, Oregon, United States, 97239 | |
| United States, Washington | |
| For additional information regarding sites for this trial call 919-319-9374 | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Emergent Product Development Seattle LLC
Investigators
| Study Director: | Scott Stromatt, MD | Emergent Product Development Seattle LLC |
More Information
No publications provided
| Responsible Party: | Emergent Product Development Seattle LLC |
| ClinicalTrials.gov Identifier: | NCT00614042 History of Changes |
| Other Study ID Numbers: | 16007 |
| Study First Received: | January 25, 2008 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emergent Product Development Seattle LLC:
|
CLL NHL TRU-016 chronic lymphocytic leukemia non-Hodgkin's lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013