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Non-Hodgkin's LymphomaPhase 2NCT01998893

A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

A Phase 2 study testing rituximab [MabThera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 11 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 study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
rituximab [MabThera/Rituxan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
11 sitesGermany
Study dates
Jan 1997to Feb 2008
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

  • adult patients >= 18 years of age;
  • centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
  • relapse after chemotherapy (with or without interferon maintenance therapy).

Who cannot join

  • primary refractory lymphomas;
  • more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
  • clinically significant cardiac disease.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Study site

    Cologne, 50924

  • Study site

    Erlangen, 91054

  • Study site

    Göttingen, 37075

  • Study site

    Grenzach-Wyhlen, 79639

  • Study site

    Hanover, 30625

  • Study site

    Homburg/saar, 66424

  • Study site

    München, 80336

  • Study site

    München, 81377

  • Study site

    Münster, 48129

  • Study site

    Stuttgart, 70376

  • Study site

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.

Being tested
rituximab [MabThera/Rituxan]
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

    375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Study groups in NCT01998893
Study groupRoleWhat they receive
MabThera/RituxanExperimentalNot described
Receives: Drug: rituximab [MabThera/Rituxan]

What is being measured

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

  1. Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)

    Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.

    Measured: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

Secondary outcomes (6)

  1. Number of Participants With a Clinical Response

    Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.

    Measured: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

  2. Time to Best Response

    The median time, in months, from start of the treatment (first application) until best response (PR or CR).

    Measured: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

  3. Duration of Remission

    Median time, in months, between the documentation of CR or PR and PD in clinical responders.

    Measured: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

  4. Time to Progression

    The median time, in months, from the start of treatment (first application) until detection of PD.

    Measured: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)

  5. Overall Survival (OS)

    OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.

    Measured: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)

  6. Number of Participants With a Clinical Response to Re-Treatment

    Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.

    Measured: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).

Timeline

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

  1. First posted2 Dec 2013 (estimated)
  2. Study startJan 1997
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998893
Sponsor's protocol ID
M39004
Status last verified
Oct 2014
First submitted
25 Nov 2013
Last updated
3 Dec 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab [MabThera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 11 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 3 inclusion and 3 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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 4 Nov 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?

Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) (time frame: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)). 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 NCT01998893.

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 3 Dec 2014.

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