Non-Hodgkin's LymphomaPhase 1NCT00354926
Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma
A Phase 1 study testing AME-133v (LY2469298) in people with Non-Hodgkin's Lymphoma, run by Applied Molecular Evolution at 11 sites in United States.
Trial summary
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- AME-133v (LY2469298)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2006to Jan 2009
- 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
- To be included in the study protocol, subjects have to meet all of the following criteria.
- Have morphologically confirmed diagnosis of CD-20+ follicular B-cell non-Hodgkin's lymphoma;
- Have the low affinity form of FcγRIIIa (F/F or F/V at position 158) as determined by FcR genotyping;
- Have measurable disease. Measurable masses (such as enlarged lymph nodes) must have a clearly defined bi-dimensional diameter of at least 1.5 x 1.5 cm on physical examination or ≤ 1.5 cm in one of the dimensions by CT, MRI, or plain radiograph;
- Have received prior treatment with chemotherapy given without rituximab; OR, Have not relapsed or progressed within 120 days (inclusive) of the last infusion of rituximab;
- Be 18 years of age or greater;
Show all 21Show fewer
- Have a negative pregnancy test, if relevant. Women of childbearing potential (not postmenopausal for at least one year and not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. To do this, they must agree to use a medically acceptable contraceptive regimen;
- Have a performance status of 0 to 2 on the ECOG performance scale;
- Have adequate hematopoietic, renal, and hepatic function defined as:
- Absolute neutrophil count greater than 1,500/mm³;
- Platelet count greater than 75,000/mm³;
- Hemoglobin at least 8 g/dL;
- Serum creatinine ≤ 1.5x upper limit of normal;
- Total bilirubin ≤ 1.5x upper limit of normal;
- ALT ≤ 1.5 x upper limit of normal;
- Alkaline phosphatase ≤ 1.5x upper limit of normal.
- No evidence of hepatitis B or C infection (no detectable HBV DNA or HCV RNA);
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 30 days prior to study enrollment;
- Have discontinued all high-dose corticosteroid therapy at least 30 days prior to study enrollment (≤ 10 mg/day of Prednisone or equivalent is allowable);
- Have life expectancy of more than 3 months;
- Be able to give written informed consent.
Who cannot join
- Subjects with any of the following exclusions are not allowed to participate in the study.
- Allergy to monoclonal antibodies or any of the study drug components;
- Concurrent malignancy that could complicate interpretation of response evaluation, including any histologic evidence of diffuse B-cell lymphoma. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions;
- Significant cardiac disease (e.g. NYHA CHF of class III or IV, history of MI within one year prior to study Day 1, unstable angina, uncontrolled hypertension, clinically significant cardiac arrhythmia (CTCAE Grade 2 or higher), or clinically significant baseline ECG or MUGA abnormality.
- Positive test for serum cardiac troponins (cTnI or cTnT assay; special processing required, and the same assay must be used throughout the study; see Study Reference Manual)
- Active infection requiring oral or i.v. antibiotics;
Show all 10Show fewer
- Administration of blood transfusions or red blood cell growth factors within 10 days preceding enrollment into the protocol;
- Administration of white cell growth factors within 28 days preceding enrollment into the protocol;
- Concomitant nonmalignant disease(s) which could interfere with implementation of the protocol, make the study results difficult to interpret, or which represent additional safety risks;
- History of HIV-associated non-Hodgkin's lymphoma.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama Medical Center
Birmingham, Alabama, 35249
University of Virginia Health System
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Iowa
Iowa City, Iowa, 52242
Nevada Cancer Institute
Las Vegas, Nevada, 89135
UCLA Medical Hematology and Oncology
Los Angeles, California, 90095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Read the detailed description
The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- AME-133v (LY2469298)
- Keywords
- Non-Hodgkin's Lymphoma, rituximab, humanized monoclonal antibody, anti-CD20 monoclonal antibody
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AME-133v (LY2469298)Biological
IV 4X weekly X 4
| Study group | Role | What they receive |
|---|---|---|
| AME 133v | Experimental | All subjects will receive weekly intravenous infusions of AME-133v. Each subject will receive a total of 4 infusions administered once a week for 3 consecutive weeks. Receives: Biological: AME-133v (LY2469298) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Until the patient is off study (an average of 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Evolution
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Link, MD, Principal investigator, University of IowaAndres Forero-Torres, MD, Principal investigator, University of Alabama Medical CenterNam Dang, MD, Principal investigator, Nevada Cancer InstituteSven de Vos, MD, PhD, Principal investigator, University of California, Los AngelesKristen Ganjoo, MD, Principal investigator, Stanford UniversityBrad Pohlman, MD, Principal investigator, The Cleveland ClinicMitchell R. Smith, MD, PhD, Principal investigator, Fox Chase Cancer CenterMichael E. Williams, MD, Principal investigator, University of Virginia Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354926
- Sponsor's protocol ID
- AME 06.133v.A
- Status last verified
- Jan 2013
- First submitted
- 18 Jul 2006
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ganjoo KN, de Vos S, Pohlman BL, Flinn IW, Forero-Torres A, Enas NH, Cronier DM, Dang NH, Foon KA, Carpenter SP, Slapak CA, Link BK, Smith MR, Mapara MY, Wooldridge JE. Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal antibody, in low-affinity FcgammaRIIIa patients with previously treated follicular lymphoma. Leuk Lymphoma. 2015 Jan;56(1):42-8. doi: 10.3109/10428194.2014.911859. Epub 2014 Jul 14.
PubMed 24717109
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00354926
- Acronym / sponsor ID
- AME 06.133v.A
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, rituximab, humanized monoclonal antibody, anti-CD20 monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Applied Molecular EvolutionIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Jul 2006 (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.
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Detailed description
The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AME 133v | Experimental | Biological: AME-133v (LY2469298)All subjects will receive weekly intravenous infusions of AME-133v. Each subject will receive a total of 4 infusions administered once a week for 3 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- To be included in the study protocol, subjects have to meet all of the following criteria.
- Have morphologically confirmed diagnosis of CD-20+ follicular B-cell non-Hodgkin's lymphoma;
- Have the low affinity form of FcγRIIIa (F/F or F/V at position 158) as determined by FcR genotyping;
- Have measurable disease. Measurable masses (such as enlarged lymph nodes) must have a clearly defined bi-dimensional diameter of at least 1.5 x 1.5 cm on physical examination or ≤ 1.5 cm in one of the dimensions by CT, MRI, or plain radiograph;
- Have received prior treatment with chemotherapy given without rituximab; OR, Have not relapsed or progressed within 120 days (inclusive) of the last infusion of rituximab;
Key exclusion criteria (10 listed)
- Subjects with any of the following exclusions are not allowed to participate in the study.
- Allergy to monoclonal antibodies or any of the study drug components;
- Concurrent malignancy that could complicate interpretation of response evaluation, including any histologic evidence of diffuse B-cell lymphoma. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions;
- Significant cardiac disease (e.g. NYHA CHF of class III or IV, history of MI within one year prior to study Day 1, unstable angina, uncontrolled hypertension, clinically significant cardiac arrhythmia (CTCAE Grade 2 or higher), or clinically significant baseline ECG or MUGA abnormality.
- Positive test for serum cardiac troponins (cTnI or cTnT assay; special processing required, and the same assay must be used throughout the study; see Study Reference Manual)
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 |
|---|---|---|
| AME-133v (LY2469298)IV 4X weekly X 4 | Biological | AME 133v |
Primary outcome
Adverse Events
Time frame: Until the patient is off study (an average of 10 months)
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 7 Jan 2016.
- Derived from this study: PubMed 24717109Ganjoo KN, de Vos S, Pohlman BL, Flinn IW, Forero-Torres A, Enas NH, Cronier DM, Dang NH, Foon KA, Carpenter SP, Slapak CA, Link BK, Smith MR, Mapara MY, Wooldridge JE. Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal antibody, in low-affinity FcgammaRIIIa patients with previously treated follicular lymphoma. Leuk Lymphoma. 2015 Jan;56(1):42-8. doi: 10.3109/10428194.2014.911859. Epub 2014 Jul 14.
Related trials for Non-Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
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.
Brian Link, MD principal investigator
University of Iowa
Andres Forero-Torres, MD principal investigator
University of Alabama Medical Center
Nam Dang, MD principal investigator
Nevada Cancer Institute
11 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 AME-133v (LY2469298) in people with Non-Hodgkin's Lymphoma, run by Applied Molecular Evolution at 11 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 21 inclusion and 10 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Adverse Events (time frame: Until the patient is off study (an average of 10 months)). 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 NCT00354926, which also lists 1 linked publication.
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 7 Jan 2016.