Chronic Lymphocytic Leukemia (CLL)Phase 1NCT00614042
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
A Phase 1 study testing TRU-016 (anti-CD37 protein therapeutic) in people with Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL), run by Aptevo Therapeutics at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
- What is being tested?
- TRU-016 (anti-CD37 protein therapeutic)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2008to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
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
Birmingham, Alabama, 35294
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
Durham, North Carolina, 27710
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
Portland, Oregon, 97239
For additional information regarding sites for this trial call 919-319-9374
Seattle, Washington, 98109
About this study
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
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.
Read the 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.
- Being tested
- TRU-016 (anti-CD37 protein therapeutic)
- Keywords
- CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRU-016 (anti-CD37 protein therapeutic)Drug
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose escalation and expansion cohorts Receives: Drug: TRU-016 (anti-CD37 protein therapeutic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
Measured: 4 weeks after treatment
Secondary outcomes (1)
Preliminary indication of response as defined by NCI 1996 criteria
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptevo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Stromatt, MD, Study director, Aptevo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614042
- Sponsor's protocol ID
- 16007
- Status last verified
- Jun 2017
- First submitted
- 25 Jan 2008
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pagel JM, Spurgeon SE, Byrd JC, Awan FT, Flinn IW, Lanasa MC, Eisenfeld AJ, Stromatt SC, Gopal AK. Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR() therapeutic protein, for relapsed or refractory NHL patients. Br J Haematol. 2015 Jan;168(1):38-45. doi: 10.1111/bjh.13099. Epub 2014 Aug 22.
PubMed 25146490Byrd JC, Pagel JM, Awan FT, Forero A, Flinn IW, Deauna-Limayo DP, Spurgeon SE, Andritsos LA, Gopal AK, Leonard JP, Eisenfeld AJ, Bannink JE, Stromatt SC, Furman RR. A phase 1 study evaluating the safety and tolerability of otlertuzumab, an anti-CD37 mono-specific ADAPTIR therapeutic protein in chronic lymphocytic leukemia. Blood. 2014 Feb 27;123(9):1302-8. doi: 10.1182/blood-2013-07-512137. Epub 2013 Dec 31.
PubMed 24381226
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00614042
- Acronym / sponsor ID
- 16007
- Keywords
- CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Aptevo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TRU-016 (anti-CD37 protein therapeutic)Dose escalation and expansion cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- ECOG performance status </= 2
- SGOT, SGPT </= 2.0 x upper limit of normal
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRU-016 (anti-CD37 protein therapeutic)TRU-016 administered via IV infusion weekly for 8 weeks and then monthly | Drug | 1 |
Primary outcome
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
Time frame: 4 weeks after treatment
1 secondary outcome
Preliminary indication of response as defined by NCI 1996 criteria
Time frame: 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Results publication: PubMed 25146490Pagel JM, Spurgeon SE, Byrd JC, Awan FT, Flinn IW, Lanasa MC, Eisenfeld AJ, Stromatt SC, Gopal AK. Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR() therapeutic protein, for relapsed or refractory NHL patients. Br J Haematol. 2015 Jan;168(1):38-45. doi: 10.1111/bjh.13099. Epub 2014 Aug 22.
- Derived from this study: PubMed 24381226Byrd JC, Pagel JM, Awan FT, Forero A, Flinn IW, Deauna-Limayo DP, Spurgeon SE, Andritsos LA, Gopal AK, Leonard JP, Eisenfeld AJ, Bannink JE, Stromatt SC, Furman RR. A phase 1 study evaluating the safety and tolerability of otlertuzumab, an anti-CD37 mono-specific ADAPTIR therapeutic protein in chronic lymphocytic leukemia. Blood. 2014 Feb 27;123(9):1302-8. doi: 10.1182/blood-2013-07-512137. Epub 2013 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Stromatt, MD study director
Aptevo Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRU-016 (anti-CD37 protein therapeutic) in people with Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL), run by Aptevo Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00614042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.