Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00614042 |
Recruitment Status :
Completed
First Posted : February 13, 2008
Last Update Posted : June 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia (CLL) Non-Hodgkin's Lymphoma (NHL) | Drug: TRU-016 (anti-CD37 protein therapeutic) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Dose escalation and expansion cohorts
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Drug: TRU-016 (anti-CD37 protein therapeutic)
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly |
- Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL [ Time Frame: 4 weeks after treatment ]
- Preliminary indication of response as defined by NCI 1996 criteria [ Time Frame: 3 months after treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614042
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 |
Study Director: | Scott Stromatt, MD | Aptevo Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Aptevo Therapeutics |
ClinicalTrials.gov Identifier: | NCT00614042 |
Other Study ID Numbers: |
16007 |
First Posted: | February 13, 2008 Key Record Dates |
Last Update Posted: | June 28, 2017 |
Last Verified: | June 2017 |
CLL NHL TRU-016 chronic lymphocytic leukemia non-Hodgkin's lymphoma |
Lymphoma Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |