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Non-Hodgkin's LymphomaPhase 3NCT00269113

A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

A Phase 3 study testing rituximab [MabThera/Rituxan] and Standard chemotherapy in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 33 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
rituximab [MabThera/Rituxan] and Standard chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
33 sitesGermany
Study dates
Sep 1998to Apr 2009
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients >=18 years of age;
  • advanced, low-grade non-Hodgkin's and mantle cell lymphoma.

Who cannot join

  • possibility of curative radiation therapy;
  • secondary NHL;
  • participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
  • concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Germany33 sites

  • Study site

    Berlin, 12203

  • Study site

    Berlin, 13122

  • Study site

    Bochum, 44791

  • Study site

    Bonn, 53127

  • Study site

    Borna, 04552

  • Study site

    Chemnitz, 09113

  • Study site

    Cottbus, 03046

  • Study site

    Dresden, 01067

  • Study site

    Dresden, 01307

  • Study site

    Dülmen, 48249

  • Study site

    Erfurt, 99089

  • Study site

    Frankfurt (Oder), 15236

  • Study site

    Greifswald, 17475

  • Study site

    Güstrow, 18273

  • Study site

    Halle, 06110

  • Study site

    Halle, 06120

  • Study site

    Jena, 07743

  • Study site

    Jena, 07747

  • Study site

    Leipzig, 04103

  • Study site

    Leipzig, 04315

  • Study site

    Magdeburg, 39120

  • Study site

    Magdeburg, 39130

  • Study site

    Marburg, 35043

  • Study site

    Neubrandenburg, 17036

  • Study site

    Nordhausen, 99734

  • Study site

    Potsdam, 14467

  • Study site

    Riesa, 01589

  • Study site

    Rostock, 18055

  • Study site

    Rostock, 18057

  • Study site

    Schwerin, 19049

  • Study site

    Stralsund, 18435

  • Study site

    Trier, 54290

  • Study site

    Zella-Mehlis, 98544

Other trials in Germany

About this study

Official title: A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Being tested
rituximab [MabThera/Rituxan], Standard chemotherapy
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.

  • rituximab [MabThera/Rituxan]Drug

    375mg/m2 iv monthly for 8 cycles

  • Standard chemotherapyDrug

    As prescribed

Study groups in NCT00269113
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: rituximab [MabThera/Rituxan]; Drug: Standard chemotherapy
2Active comparatorNot described
Receives: Drug: Standard chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving CR or PR at the End of Therapy

    CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.

    Measured: Following completion of 6 cycles (24 weeks)

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months

    PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL). Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.

    Measured: 24 months

  2. Overall Survival (OS) - Percentage of Participants Alive at 24 Months

    OS was defined as interval from randomization to date of death of any cause. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.

    Measured: Month 24

  3. Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months

    EFS was defined as the interval from randomization date to therapy failure. Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause. NC is defined as tumor regression of <25%, stable disease and progression ≤25%. PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%. MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.

    Measured: Month 24

  4. Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months

    DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.

    Measured: Month 24

  5. Response Duration - Percentage of Participants Event Free at 24 Months

    Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.

    Measured: Month 24

  6. Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months

    Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2005 (estimated)
  2. Study startSep 1998
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269113
Sponsor's protocol ID
M39023
Status last verified
Jul 2015
First submitted
22 Dec 2005
Last updated
23 Jul 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab [MabThera/Rituxan] and Standard chemotherapy in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 33 sites in Germany.

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 2 inclusion and 4 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany. 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 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?

Yes. Results are posted in the registry (first posted 23 Jul 2015). 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?

Percentage of Participants Achieving CR or PR at the End of Therapy (time frame: Following completion of 6 cycles (24 weeks)). 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 NCT00269113.

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 23 Jul 2015.

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