Diffuse Large B Cell LymphomaPhase 2/3TRENDNCT01277172
TREatment of degeNerative and Neoplastic Diseases With Rituximab
A Phase 2/3 study testing Rituximab in people with Diffuse Large B Cell Lymphoma, run by Probiomed S.A. de C.V. at 1 site in Mexico.
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 PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 2/3
- 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.
- CD20+ lymphoma cells at screening.
- > 18 years of age at screening.
- Ann Arbor Stages I-IV at screening.
- Any IPI score at screening.
- Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale > 60 at screening.
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- Left ventricular ejection fraction > 50%.
- 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
- Hodgkin lymphoma.
- Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
- Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
- Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
- Function Liver tests >2 x upper normal values.
- Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
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- Any other serious active disease or co-morbid medical condition.
- Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
- Pregnant or breast-feeding 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 day 1 of study treatment.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
INCan
México, D.f., 14080
Ramiro Espinoza Zamora, MD
About this study
Official title: Comparative,Randomized,Double Blind Study to Evaluate Biologic Effect and Safety of PBO-326 (Rituximab), Associated to CHOP-14 Compared With Mabthera (Rituximab) Associated to CHOP-14 in B Cells CD20+ Diffuse Non-Hodgkin Lymphoma Patients
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.
Read the detailed description
At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.
Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.
Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Rituximab
- Keywords
- DLBCL, pharmacokinetics, pharmacodynamics, Rituximab, LymphomaLymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell, Disorders Lymphatic Diseases, Immunoproliferative Disorders, Antineoplastic Agents, Adverse Effects
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Immunoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Also called Monoclonal Antibody against CD20
375 mg/m2 IV every 2 weeks for 6 cycles
RituximabBiological
Also called Monoclonal Antibody against CD20
375 mg/m2 IV every 2 weeks for 6 cycles
RituximabBiological
Also called Monoclonal Antibody against CD20
375 mg/m2 IV every 2 weeks for 6 cycles
RituximabBiological
Also called Monoclonal antibody against CD20
375 mg/m2 IV every 14 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Group 1 / PBO-326 | Experimental | This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles. Receives: Biological: Rituximab |
| Group 2 / Mabthera | Active comparator | This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles. Receives: Biological: Rituximab |
| Group 3 / PBO-326 | Experimental | This group will be treated six cycles with PBO-326 Receives: Biological: Rituximab |
| Group 4 / Mabthera | Active comparator | This group will be treated six cycles with Mabthera Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal and final serum CD 20 levels comparison.
Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8.
Measured: Every 14 days for the duration of treatment
Secondary outcomes (1)
Comparison of safety of PBO-326 versus Mabthera
Adverse events will be observed and recorded in relation to acute infusion events (number of cases and severity of hypotension, hipertension, headache, and all cardiovascular events previously reported by Mabthera) as well as long term effects over key hematological cells (number of cases and severity of neutropenia, trombocytopenia, leucopenia) per visit.
Measured: Every 14 days measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Probiomed S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jorge Revilla Beltri, MD, Study director, Probiomed S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277172
- Sponsor's protocol ID
- PRO-1908
- Other IDs
- PRO1908TREND
- Acronym
- TREND
- Status last verified
- Jan 2011
- First submitted
- 8 Jan 2011
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative,Randomized,Double Blind Study to Evaluate Biologic Effect and Safety of PBO-326 (Rituximab), Associated to CHOP-14 Compared With Mabthera (Rituximab) Associated to CHOP-14 in B Cells CD20+ Diffuse Non-Hodgkin Lymphoma Patients
- ClinicalTrials.gov ID
- NCT01277172
- Acronym / sponsor ID
- TREND / PRO-1908
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- DLBCL, pharmacokinetics, pharmacodynamics, Rituximab, LymphomaLymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Probiomed S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 14 Jan 2011 (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 PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.
Detailed description
At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.
Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.
Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 / PBO-326 | Experimental | Biological: RituximabThis group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles. |
| Group 2 / Mabthera | Active comparator | Biological: RituximabThis group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles. |
| Group 3 / PBO-326 | Experimental | Biological: RituximabThis group will be treated six cycles with PBO-326 |
| Group 4 / Mabthera | Active comparator | Biological: RituximabThis group will be treated six cycles with Mabthera |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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.
- CD20+ lymphoma cells at screening.
- > 18 years of age at screening.
- Ann Arbor Stages I-IV at screening.
- Any IPI score at screening.
Key exclusion criteria (10 listed)
- Hodgkin lymphoma.
- Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
- Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
- Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
- Function Liver tests >2 x upper normal values.
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 |
|---|---|---|
| RituximabAlso: Monoclonal Antibody against CD20375 mg/m2 IV every 2 weeks for 6 cycles | Biological | Group 1 / PBO-326 |
| RituximabAlso: Monoclonal Antibody against CD20375 mg/m2 IV every 2 weeks for 6 cycles | Biological | Group 2 / Mabthera |
| RituximabAlso: Monoclonal Antibody against CD20375 mg/m2 IV every 2 weeks for 6 cycles | Biological | Group 3 / PBO-326 |
| RituximabAlso: Monoclonal antibody against CD20375 mg/m2 IV every 14 days for 6 cycles | Biological | Group 4 / Mabthera |
Primary outcome
Basal and final serum CD 20 levels comparison.
Time frame: Every 14 days for the duration of treatment
Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8.
1 secondary outcome
Comparison of safety of PBO-326 versus Mabthera
Time frame: Every 14 days measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
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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.
Jorge Revilla Beltri, MD study director
Probiomed S.A. de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab in people with Diffuse Large B Cell Lymphoma, run by Probiomed S.A. de C.V. at 1 site in Mexico.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Revilla Beltri, MD ((00+1) 55 25811969, jorge.revilla@probiomed.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal and final serum CD 20 levels comparison. (time frame: Every 14 days for the duration of treatment). 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 14 Jan 2011.