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Lymphoma of Mucosa-Associated Lymphoid TissuePhase 2NCT00656812

Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma

A Phase 2 study testing Rituximab and 2-CdA in people with Lymphoma of Mucosa-Associated Lymphoid Tissue, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 5 sites in Austria.

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

The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab and 2-CdA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesAustria
Study dates
May 2008to Sep 2011
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of MALT lymphoma of any localization
  • Disseminated disease upon diagnosis in case of gastric lymphoma or first or greater relapse after local therapy (including gastrectomy or surgery), prior chemotherapy or HP-eradication. In addition, also patients with localized gastric lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication can be included in the study.
  • Measurable disease
  • ECOG performance status of 0,1 or 2
  • Age at least 18 years
  • Life expectancy of at least 3 months
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  • Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range (ULN), alkaline phosphatase < 2.5 x ULN, serum bilirubin < 2.0 mg/dl)
  • Patient must be willing and able to comply with the protocol for the entire study duration
  • Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period
  • Patient's written informed consent

Who cannot join

  • Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse large cell lymphoma ("high grade lymphoma")
  • Use of any investigational agent 30 days prior to inclusion
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
  • Major surgery, other than diagnostic surgery, within the last 4 weeks
  • Evidence of CNS involvement
  • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
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  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
  • Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophile count (segmented + bands) <1.0 x 109/L
  • Patients with active opportunistic infections
  • Pregnant or breast feeding women

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Austria5 sites

  • Universitätsklinikum Graz

    Graz, A-8036

  • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin

    Innsbruck, A-6020

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • Universitaetsklinik f. Innere Medizin III

    Salzburg, A-5020

  • AKH Wien / Universitaetsklinik fuer Innere Medizin I

    Vienna, A-1090

Other trials in Austria

About this study

Official title: Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT).

Read the detailed description

Currently, there is no chemotherapeutic standard treatment for patients with MALT lymphoma either presenting with disseminated disease or with relapsing/refractory disease following local treatment (including radiation) or eradication of HP. Various compounds have been tested, including alkylating agents such as cyclophosphamide or chlorambucil, the nucleoside analog cladribine (2CdA), as well as combination regimens including CHOP or MCP (mitoxantrone, chlorambucil, prednisone), but only limited data exists from prospective trials. Thus, trials to evaluate the potential of new compounds in patients with advanced MALT lymphoma are not only justified, but seem warranted.

While systemic approaches were until recently thought to be justified only in patients with disseminated disease, emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment. This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion, where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival.

Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date. This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue.

Being tested
Rituximab, 2-CdA
Keywords
advanced MALT lymphoma, Rituximab, 2CdA, chemotherapy, immunotherapy
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called MabThera

    375 mg/m2 on day 1 of a 21-day treatment cycle

  • 2-CdADrug

    Also called Litak

    0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle

Study groups in NCT00656812
Study groupRoleWhat they receive
Treatment ArmExperimentalCombination therapy Rituximab plus 2CdA
Receives: Drug: Rituximab; Drug: 2-CdA

What is being measured

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

  1. Response rate

    Measured: After 2, 4 and 6 cycles of therapy

Secondary outcomes (2)

  1. Progression-free survival and relapse-free survival

    Measured: Duration of study

  2. Occurrence of adverse events

    Measured: Duration of study

Timeline

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

  1. First posted11 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00656812
Sponsor's protocol ID
AGMT_MALT
Other IDs
EudraCT 2008-000767-41
Status last verified
Dec 2013
First submitted
2 Apr 2008
Last updated
24 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and 2-CdA in people with Lymphoma of Mucosa-Associated Lymphoid Tissue, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 5 sites in Austria.

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 10 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: finished, as of the sponsor's last update on 24 Dec 2013. 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 Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate (time frame: After 2, 4 and 6 cycles of therapy). 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 NCT00656812.

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 24 Dec 2013.

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