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Diffuse Large B-Cell LymphomaPhase 2NCT01144403

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

A Phase 2 study testing Cyclophosphamide, Fludarabine and Mitoxantrone in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 8 sites in Romania.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Cyclophosphamide, Fludarabine and Mitoxantrone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
8 sitesRomania
Study dates
Jun 2010to Aug 2014
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 participants, >/=18 years of age
  • untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
  • known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • adequate hematological, renal and hepatic function

Who cannot join

  • known hypersensitivity to murine proteins or chemotherapy regimen
  • previous first-line therapy
  • history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
  • active infection
  • clinically significant cardiac disease
  • regular corticosteroid treatment in the 4 weeks prior to first dose of study drug

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Romania8 sites

  • Study site

    Brasov, 500326

  • Study site

    Bucharest, 005098

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 030171

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Iași, 700111

  • Study site

    Târgu Mureş, 540136

  • Study site

    Timișoara, 300079

Other trials in Romania

About this study

Official title: A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Being tested
Cyclophosphamide, Fludarabine, Mitoxantrone, Rituximab
Medical subject headings
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

    as prescribed, 6 cycles

  • FludarabineDrug

    as prescribed, 6 cycles

  • MitoxantroneDrug

    as prescribed, 6 cycles

  • RituximabDrug

    Also called Mabthera/Rituxan

    375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Study groups in NCT01144403
Study groupRoleWhat they receive
RituximabExperimentalRituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mitoxantrone; Drug: Rituximab

What is being measured

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

  1. Overall Response Rate (ORR)

    Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.

    Measured: Up to 50 months (approximately)

Secondary outcomes (3)

  1. Overall Survival (OS)

    Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.

    Measured: From the time of enrollment until death due to any cause (up to 50 months [approximately])

  2. Progression-free Survival (PFS)

    PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

    Measured: From the time of enrollment until death due to any cause (up to 50 months [approximately])

  3. Number of Participant With Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.

    Measured: Up to 50 months (approximately)

Timeline

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

  1. First posted15 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144403
Sponsor's protocol ID
ML22489
Other IDs
2009-011433-27, 2009
Status last verified
Jul 2016
First submitted
14 Jun 2010
Last updated
18 Oct 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Fludarabine and Mitoxantrone in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 8 sites in Romania.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Romania. 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 29 Aug 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?

Overall Response Rate (ORR) (time frame: Up to 50 months (approximately)). 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 NCT01144403.

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 18 Oct 2016.

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