DLBCLPhase 1NCT01205737
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
A Phase 1 study testing TL011 and Rituximab in people with DLBCL, run by Teva Branded Pharmaceutical Products R&D, Inc. at 41 sites in 10 countries.
Trial summary
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DLBCL
- What is being tested?
- TL011 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 41 sitesin 10 countries
- Study dates
- Sep 2010to Sep 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.
- 2.CD20+ lymphoma cells at screening
- 18-80 (inclusive) years of age at screening
- Ann Arbor Stages I-IV at screening
- Any IPI score at screening
- ECOG good performance status (0-2) at screening
- Willing and able to provide written informed consent prior to performing study procedures
- Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion..
Who cannot join
- Any lymphoma other than CD20+ DLBCL
- History of indolent lymphoma
- DLBCL with central nervous system or meningeal involvement
- Primary gastrointestinal (MALT) lymphoma
- Bulky disease>10 cm diagnosed by imaging at screening
- Bone marrow involvement > 25% according to bone marrow biopsy at screening
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- Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
- Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
- Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
- A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
- Subjects with a history of tuberculosis or active tuberculosis at screening.
- Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
- Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
- Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
- Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
- Known allergic reactions against foreign proteins
- Subjects for whom 8 cycles of CHOP might be problematic, and have the following findings/conditions, should not be enrolled:
- Cardiac contra-indication to doxorubicin: Left ventricular ejection fraction (LVEF) < 50% according to multi-acquisition gated (MUGA) scan or 2D Echocardiogram at screening
- Neurologic contra-indication to vincristine: (e.g., peripheral neuropathy)
- Abnormal hepatic function at screening and/or baseline
- AST/ALT ≥ 3 x upper normal value (ULN) or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
- Bilirubin ≥ 2 x ULN or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
- Abnormal renal function at screening and/or baseline
- Serum creatinine ≥ 2 x ULN
- Abnormal bone marrow function at screening and/or baseline
- Platelets < 100x109/L
- Neutrophils < 1.5x109/L
- Hb < 9g/dL
- Any other serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigator Brochure of TL011)
- Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
- Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
- Treatment with any investigational drug within 90 days before planned first cycle of chemotherapy.
Trial locations and contacts
41 sites in 10 countries.
41 sites in 10 countries
Russia12 sites
Teva Investigational Site 50011
Arkhangelsk
Teva Investigational Site 50001
Chelyabinsk
Teva Investigational Site 50006
Kazan'
Teva Investigational Site 50014
Kursk
Teva Investigational Site 50005
Moscow
Teva Investigational Site 50009
Moscow
Teva Investigational Site 50010
Moscow
Teva Investigational Site 50003
Novosibirsk
Teva Investigational Site 50017
Pyatigorsk
Teva Investigational Site 50012
Saint Petersburg
Teva Investigational Site 50015
Tomsk
Teva Investigational Site 50004
Yekaterinburg
Ukraine8 sites
Teva Investigational Site 58011
Cherkasy
Teva Investigational Site 58013
Dnipropetrovsk
Teva Investigational Site 58014
Donetsk
Teva Investigational Site 58017
Khmelnytskyi
Teva Investigational Site 58010
Kyiv
Teva Investigational Site 58012
Kyiv
Teva Investigational Site 58015
Kyiv
Teva Investigational Site 58016
Simferopol
Spain6 sites
Teva Investigational Site 31005
Elche-Alicante
Teva Investigational Site 31006
Las Palmas de Gran Canaria
Teva Investigational Site 31002
Madrid
Teva Investigational Site 31001
Majadahonda-Madrid
Teva Investigational Site 31003
Valencia
Teva Investigational Site 31004
Valencia
Bulgaria5 sites
Teva Investigational Site 59005
Pleven
Teva Investigational Site 59003
Plovdiv
Teva Investigational Site 59001
Sofia
Teva Investigational Site 59002
Sofia
Teva Investigational Site 59004
Varna
Latvia3 sites
Teva Investigational Site 56002
Daugavpils
Teva Investigational Site 56001
Riga
Teva Investigational Site 56003
Riga
Estonia2 sites
Teva Investigational Site 55001
Tallinn
Teva Investigational Site 55002
Tartu
Italy2 sites
Teva Investigational Site 30001
Florence
Teva Investigational Site 30002
Naples
About this study
Official title: A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL011Biological
375 mg/m2 iv every 3 weeks for 8 cycles
RituximabBiological
375 mg/m2 iv every 3 weeks for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| TL011 | Experimental | Not described Receives: Biological: TL011 |
| MabThera® | Active comparator | Not described Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC during a dosing interval for Rituximab
Measured: 21 weeks
Secondary outcomes (1)
PK and PD parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, PhD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205737
- Sponsor's protocol ID
- NHL-TL011-102
- Status last verified
- Oct 2013
- First submitted
- 17 Sep 2010
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
- ClinicalTrials.gov ID
- NCT01205737
- Acronym / sponsor ID
- NHL-TL011-102
- Conditions
- DLBCL
- Keywords
- DLBCL, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Sep 2010 (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 is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL011 | Experimental | Biological: TL011 |
| MabThera® | Active comparator | Biological: Rituximab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.
- 2.CD20+ lymphoma cells at screening
- 18-80 (inclusive) years of age at screening
- Ann Arbor Stages I-IV at screening
- Any IPI score at screening
Key exclusion criteria (33 listed)
- Any lymphoma other than CD20+ DLBCL
- History of indolent lymphoma
- DLBCL with central nervous system or meningeal involvement
- Primary gastrointestinal (MALT) lymphoma
- Bulky disease>10 cm diagnosed by imaging at screening
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 |
|---|---|---|
| TL011375 mg/m2 iv every 3 weeks for 8 cycles | Biological | TL011 |
| Rituximab375 mg/m2 iv every 3 weeks for 8 cycles | Biological | MabThera® |
Primary outcome
AUC during a dosing interval for Rituximab
Time frame: 21 weeks
1 secondary outcome
PK and PD parameters
Time frame: Throughout study
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 22 Oct 2013.
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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.
Mariano Provencio, MD, PhD principal investigator
Hospital Universitario Puerta de Hierro
41 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TL011 and Rituximab in people with DLBCL, run by Teva Branded Pharmaceutical Products R&D, Inc. at 41 sites in 10 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 8 inclusion and 33 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 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Russia, Ukraine, Spain, Bulgaria, Latvia and 5 more countries. 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?
AUC during a dosing interval for Rituximab (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2013.