Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell LymphomaNCT02486952
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
An observational study of Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 5 sites in Serbia.
Trial summary
Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- Cyclophosphamide, Hydroxydaunorubicin and Oncovin
- How many people
- 154 participants
- Where
- 5 sitesSerbia
- Study dates
- Aug 2005to Jan 2011
- Phase
- Observational
- 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
Study population: Participants with aggressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma [DLBCL])
Who may be able to join
- Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification
- Age > or =18 years
- Performance status < or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter
Who cannot join
- Transformed lymphoma (secondary to "low-grade" follicular lymphoma)
- Grade 1, 2 or 3a follicular lymphoma
- Primary or secondary central nervous system (CNS) involvement
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- Poor renal function: Serum creatinine > 2.0 mg/dl (177 micromol/L)
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- Pregnancy
- Poor hepatic function: total bilirubin > 2.0 mg/dl (34 micromol/L), aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) or alkaline phosphatase (AP) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
- Known human immunodeficiency virus (HIV) infection or active viral hepatitis, specifically hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial
- Life expectancy < 6 months
- Known sensitivity or allergy to murine products
- Treatment within a clinical trial within 30 days prior to trial entry
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Serbia5 sites
Study site
Belgrade, 11000
Study site
Belgrade, 11070
Study site
Kamenitz, 21204
Study site
Kragujevac, 34000
Study site
Niš, 18000
About this study
Official title: Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.
- Being tested
- Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone, Rituximab
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Recurrence, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
HydroxydaunorubicinDrug
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
OncovinDrug
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
PrednisoneDrug
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
RituximabDrug
Also called MabThera
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
| Study group | Role | What they receive |
|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason. Receives: Drug: Cyclophosphamide; Drug: Hydroxydaunorubicin; Drug: Oncovin; Drug: Prednisone; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Event Free Survival (EFS)
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
Measured: Up to 41 months
Secondary outcomes (1)
Percentage of Participants Who Were Alive
Percentage of participants with survival was calculated 41 months after the first dose of study treatment.
Measured: Up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2005
- Primary completionJan 2011
- Study completionJan 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.
- Other trials for Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serbian Lymphoma Group
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486952
- Sponsor's protocol ID
- ML20390
- Status last verified
- Jan 2016
- First submitted
- 29 Jun 2015
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02486952
- Acronym / sponsor ID
- ML20390
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Serbian Lymphoma Group
- Study start
- Aug 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | – | Drug: Cyclophosphamide, Drug: Hydroxydaunorubicin, Drug: Oncovin, Drug: Prednisone, Drug: RituximabParticipants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with aggressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma [DLBCL])
Key inclusion criteria (4 listed)
- Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification
- Age > or =18 years
- Performance status < or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter
Key exclusion criteria (13 listed)
- Transformed lymphoma (secondary to "low-grade" follicular lymphoma)
- Grade 1, 2 or 3a follicular lymphoma
- Primary or secondary central nervous system (CNS) involvement
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
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 |
|---|---|---|
| CyclophosphamideAdministered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug. | Drug | Diffuse Large B-Cell Lymphoma (DLBCL) |
| HydroxydaunorubicinAdministered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug. | Drug | Diffuse Large B-Cell Lymphoma (DLBCL) |
| OncovinAdministered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug. | Drug | Diffuse Large B-Cell Lymphoma (DLBCL) |
| PrednisoneAdministered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug. | Drug | Diffuse Large B-Cell Lymphoma (DLBCL) |
| RituximabAlso: MabTheraAdministered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug. | Drug | Diffuse Large B-Cell Lymphoma (DLBCL) |
Primary outcome
Probability of Event Free Survival (EFS)
Time frame: Up to 41 months
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
1 secondary outcome
Percentage of Participants Who Were Alive
Time frame: Up to 41 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Clinical Trials study director
Hoffmann-La Roche
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 5 sites in Serbia.
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 4 inclusion and 13 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Serbia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2016). 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?
Probability of Event Free Survival (EFS) (time frame: Up to 41 months). 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 Feb 2016.