Lymphoma, Large Cell, DiffusePhase 2NCT00532259
CT-011 MAb in DLBCL Patients Following ASCT
A Phase 2 study testing CT-011 in people with Lymphoma, Large Cell, Diffuse and Lymphoma, Mixed Cell, Diffuse, run by CureTech Ltd at 27 sites in 3 countries.
Trial summary
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma
- What is being tested?
- CT-011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 27 sitesin 3 countries
- Study dates
- Oct 2007to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient's age is 18 years or older, both genders.
- Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
- The lymphoma is chemosensitive.
- The lymphoma did not progress since pre-transplant chemotherapy.
- ECOG performance status 0-1.
Who cannot join
- Serious other illness.
- Active autoimmune disease.
- Type 1 diabetes.
- Known immune deficiency.
- Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
- Active bacterial, fungal, or viral infection.
Show all 9Show fewer
- Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
- Pregnant or nursing (positive pregnancy test).
- Other concurrent clinical study or investigational therapy.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States20 sites
University of Michigan
Ann Arbor, Michigan, 48109-0473
Emory University-Winship Cancer Institute
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestestern Memorial Hospital
Chicago, Illinois, 60611-3008
Rush University Medical Center
Chicago, Illinois, 60612
The University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106
Ohio State University
Colombus, Ohio, 43210
Baylor Sammons Cancer Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Cancer Center of the Carolinas
Greenville, South Carolina, 29605
M.D. Anderson Cancer Center
Houston, Texas, 77030
Moores UCSD Cancer Center
La Jolla, California, 92093-0706
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Temple University
Philadelphia, Pennsylvania, 19111-2442
The University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Scripps Cancer Center
San Diego, California, 92121
India4 sites
Gujarat Cancer and Research Institute
Ahmedabad, 380016
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, 110085
Jaslok Hospital and Research Centre
Mumbai, Maharashtra, 400026
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Israel3 sites
Rambam Medical Center
Haifa
Hadassah Medical Organization
Jerusalem
Chaim Sheba Medical Center
Tel Hashomaer, Ramat Gan
About this study
Official title: Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
- Conditions
- Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma
- Being tested
- CT-011
- Keywords
- Lymphoma, Large B-Cell, Diffuse, Transformed Follicular Lymphoma, Stem cell transplantation, Relapsed, Refractory
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-011Drug
Also called Pidilizumab
IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
| Study group | Role | What they receive |
|---|---|---|
| CT-011 | Experimental | The monoclonal antibody termed CT-011 (currently, pidilizumab). Receives: Drug: CT-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
PFS (progression-free survival ) will be determined at the eligible patient populations
Measured: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
Secondary outcomes (1)
Overall Survival
Measured: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large Cell, DiffuseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureTech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leo I Gordon, MD, Principal investigator, Northwestern UniversityArnon Nagler, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532259
- Sponsor's protocol ID
- CT-2007-01
- Status last verified
- Sep 2014
- First submitted
- 19 Sep 2007
- Last updated
- 12 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Armand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Holland HK, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. doi: 10.1200/JCO.2012.48.3685. Epub 2013 Oct 14.
PubMed 24127452
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00532259
- Acronym / sponsor ID
- CT-2007-01
- Conditions
- Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma
- Keywords
- Lymphoma, Large B-Cell, Diffuse, Transformed Follicular Lymphoma, Stem cell transplantation, Relapsed, Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CureTech LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-011 | Experimental | Drug: CT-011The monoclonal antibody termed CT-011 (currently, pidilizumab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient's age is 18 years or older, both genders.
- Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
- The lymphoma is chemosensitive.
- The lymphoma did not progress since pre-transplant chemotherapy.
- ECOG performance status 0-1.
Key exclusion criteria (9 listed)
- Serious other illness.
- Active autoimmune disease.
- Type 1 diabetes.
- Known immune deficiency.
- Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
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 |
|---|---|---|
| CT-011Also: PidilizumabIV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. | Drug | CT-011 |
Primary outcome
Progression-free Survival
Time frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
PFS (progression-free survival ) will be determined at the eligible patient populations
1 secondary outcome
Overall Survival
Time frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24127452Armand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Holland HK, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. doi: 10.1200/JCO.2012.48.3685. Epub 2013 Oct 14.
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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.
Leo I Gordon, MD principal investigator
Northwestern University
Arnon Nagler, MD principal investigator
Chaim Sheba Medical Center
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-011 in people with Lymphoma, Large Cell, Diffuse and Lymphoma, Mixed Cell, Diffuse, run by CureTech Ltd at 27 sites in 3 countries.
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 5 inclusion and 9 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, India, Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (time frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).). 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 NCT00532259, 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 12 Sep 2014.