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Diffuse Large B-Cell LymphomaPhase 2NHL-14NCT00575406

Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B-Cell Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 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

Diffuse large B-cell lymphoma is the most prevalent subgroup within malignant lymphoma. Clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin, vincristin and prednisolone (CHOP regimen); this could be further improved recently by the addition of rituximab (R-CHOP), a monoclonal antibody. 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?
Rituximab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
10 sitesAustria
Study dates
Dec 2007to Jan 2012
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 confirmed, CD20 positive, diffuse large B-cell lymphoma (DLCL)
  • measurable disease according to international criteria
  • male or female
  • age 18 years and above
  • written informed consent

Who cannot join

  • myocardial infarction within 6 months prior to study entry
  • cardiac insufficiency NYHA grade 3 or 4
  • previous treatment with chemotherapy or radiotherapy
  • CNS involvement of the disease
  • positive for HIV
  • WHO Performance Index 3 or 4
Show all 10Show fewer
  • secondary malignoma
  • concurrent disease that prohibits chemotherapy
  • known hypersensitivity towards the study interventions or their constituents
  • neutropenia or thrombopenia

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Austria10 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6806

  • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin

    Innsbruck, A-6020

  • A.ö. Landeskrankenhaus Leoben

    Leoben, A-8700

  • Krankenhaus d. Barmherzigen Schwestern Linz

    Linz, A-4010

  • Krankenhaus der Elisabethinen Linz

    Linz, A-4010

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • Universitaetsklinik f. Innere Medizin III

    Salzburg, A-5020

  • AKH Wien / Haematologie u. Haemostaseologie

    Vienna, A-1090

  • Hanusch Krankenhaus

    Vienna, A-1140

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, A-4600

Other trials in Austria

About this study

Official title: Multicentre Study to Determine the Cardiotoxicity of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone) Compared to R-COMP (Rituximab, Cyclophosphamide, Liposomal Doxorubicin, Vincristin and Prednisolone) in Patients With Diffuse Large B-Cell Lymphoma (NHL-14)

Diffuse large B-cell lymphoma is the most prevalent subgroup within malignant lymphoma. Clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin, vincristin and prednisolone (CHOP regimen); this could be further improved recently by the addition of rituximab (R-CHOP), a monoclonal antibody.

Improved response and overall survival rates make it necessary to evaluate late toxicities of the therapy regimens. Cardiotoxicity is a known risk factor of specific chemotherapies, with 7% patients being affected if doxorubicin cumulative doses are under 550mg/sqm. Retrospective data analyses indicate that this incidence of cardiotoxicity may be higher under combination chemotherapy. Liposomal doxorubicin has been shown to have lower cardiotoxic effects and at the same time equivalent or higher efficacy compared to conventional doxorubicin.

The aim of this study is to evaluate alternative regimens for the treatment of diffuse large B-cell lymphoma, substituting liposomal doxorubicin (R-COMP) for conventional doxorubicin (R-CHOP).

Being tested
Rituximab, Cyclophosphamide, Doxorubicin, liposomal Doxorubicin, Vincristin
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.

  • RituximabDrug

    Also called MabThera

    i.v., 375 mg/m2, d0 or d1 of each treatment cycle

  • CyclophosphamideDrug

    Also called Cytoxan

    i.v., 750 mg/m2, d1 of each treatment cycle

  • DoxorubicinDrug

    Also called Adriamycin

    i.v., 50 mg/m2, d1 of each treatment cycle

  • liposomal DoxorubicinDrug

    Also called Myocet

    i.v., 50 mg/m2, d1 of each treatment cycle

  • VincristinDrug

    Also called Oncovin

    i.v., 2mg, d1 of each treatment cycle

  • PrednisoloneDrug

    p.o., 100mg, d1 - d5 of each treatment cycle

Study groups in NCT00575406
Study groupRoleWhat they receive
R-CHOPActive comparatorTreatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisolone
R-COMPExperimentalTreatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: liposomal Doxorubicin; Drug: Vincristin; Drug: Prednisolone

What is being measured

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

  1. Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP

    Measured: Study duration

Secondary outcomes (7)

  1. Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity

    Measured: Study Duration

  2. Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)

    Measured: Study duration

  3. Rate of Complete Responses

    Measured: At end of treatment

  4. Difference in Overall Survival at 3 and 5 yrs

    Measured: 5 years

  5. Difference in Event-free Survival at 3 and 5 yrs

    Measured: 5 years

  6. Difference in Progression-free Survival at 3 and 5 yrs

    Measured: 5 years

  7. Difference in cause-specific death

    Measured: 5 years

Timeline

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

  1. First posted18 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00575406
Sponsor's protocol ID
NHL-14
Other IDs
EudraCT 2007-004970-24
Acronym
NHL-14
Status last verified
Aug 2013
First submitted
17 Dec 2007
Last updated
30 Aug 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B-Cell Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 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 5 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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP (time frame: Study duration). 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 NCT00575406.

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 30 Aug 2013.

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