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LymphomaNCT00544219

PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

A study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Swiss Cancer Institute at 19 sites in 2 countries.

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

RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab, cyclophosphamide and doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
19 sitesin 2 countries
Study dates
Sep 2007to Jan 2016
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL)
  • Stage I-IV disease
  • All IPI risk groups
  • Must be positron emission tomography (PET)-positive
  • At least one measurable lesion ≥ 15 mm in its shortest axis (greatest transverse diameter) for jugulodigastric and infra-carinal lymph nodes with CT scan (MRI is allowed only if CT scan cannot be performed)
  • Otherwise the shortest axis (greatest transverse diameter) must be ≥ 10 mm
Show all 17Show fewer
  • Lesions should be selected according to the following features:
  • Clearly measurable in two perpendicular dimensions
  • From as disparate regions of the body as possible
  • Include mediastinal and retroperitoneal areas of disease whenever these sites are involved
  • ECOG or WHO performance status 0-2
  • Cardiac ejection fraction ≥ 50% as assessed by echocardiography
  • Sufficient hematological values, hepatic and renal function
  • Patient condition, compliance, and geographic proximity must allow proper staging and completion of treatment and follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy

Who cannot join

  • Secondary DLBCL (in transformation)
  • Evidence of symptomatic CNS disease
  • PATIENT CHARACTERISTICS:
  • Prior or concurrent hematological malignancies
  • Patients who have had prior solid organ tumors that required no treatment over the past 5 years and are currently disease-free are allowed
  • Unstable cardiac disease within the past 6 months
Show all 16Show fewer
  • Any serious underlying medical condition (at the judgment of the investigator) that could impair the ability of the patient to participate in the study (e.g., active autoimmune disease, uncontrolled diabetes, HIV- and hepatitis-infection)
  • Known hypersensitivity to any component of the study drugs
  • PRIOR CONCURRENT THERAPY:
  • Prior chemotherapy, radiotherapy, or immunotherapy (e.g., rituximab) for lymphoma
  • Prior anthracycline treatment
  • Concurrent radiotherapy
  • Concurrent regular corticosteroids in the past 4 weeks
  • Doses ≤ 20 mg/day of prednisone for indications other than lymphoma or lymphoma-related symptoms allowed
  • Concurrent drugs contraindicated for use with the study drugs according to the Swissmedic-approved product information
  • Other concurrent experimental drugs or other anticancer therapy

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Switzerland18 sites

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Kantonspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Praxis Dr. Streit

    Baden, CH-5404

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Kantonsspital Olten

    Olten, CH-4600

  • Praxis Dr. Beretta

    Rheinfelden, CH-4310

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Italy1 site

  • European Institute of Oncology

    Milan, 20141

Other trials in Italy

About this study

Official title: Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study

RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate if an early positive positron emission tomography (PET) scan after 2 courses of rituximab with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone can be used to identify a group of patients having a poor prognosis.

Secondary

  • To compare modified PET/CT scan response criteria with revised standard response criteria.
  • To evaluate, in a prospective manner, whether a proliferation-inducing ligand (APRIL) expression is a prognostic factor in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Rituximab IV alone is continued for an additional 2 courses after completion of the initial 6 courses.

Patients undergo positron emission tomography (PET) scan prior to and after completion of study therapy. Patients also undergo PET scan after course 2, and those with a positive PET result undergo an additional PET scan after course 4.

Previously collected tumor samples are analyzed for a proliferation-inducing ligand (APRIL) expression.

After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions
Lymphoma
Keywords
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

Study groups in NCT00544219
Study groupRoleWhat they receive
R-Chop 14OtherStandard treatment
Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Procedure: positron emission tomography

What is being measured

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

  1. Event-free survival

    Measured: at 2 years

Secondary outcomes (5)

  1. Event-free survival

    Measured: at 5 years

  2. Overall survival during follow-up

    Measured: at 2 and 5 years

  3. Objective response

    Measured: at 2 years

  4. Positron emission tomography (PET) results

    Measured: at 2 years

  5. Histological results of remaining PET-positive lesion(s) after treatment

    Measured: at 2 years

Timeline

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

  1. First posted16 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionSep 2012
  4. Study completionJan 2016

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00544219
Sponsor's protocol ID
SAKK 38/07
Other IDs
SWS-SAKK-38-07, EU-20763, EUDRACT-2007-001806-26, CDR0000569869
Status last verified
May 2019
First submitted
13 Oct 2007
Last updated
15 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Juskevicius D, Jucker D, Klingbiel D, Mamot C, Dirnhofer S, Tzankov A. Mutations of CREBBP and SOCS1 are independent prognostic factors in diffuse large B cell lymphoma: mutational analysis of the SAKK 38/07 prospective clinical trial cohort. J Hematol Oncol. 2017 Mar 17;10(1):70. doi: 10.1186/s13045-017-0438-7.

    PubMed 28302137

  • Mamot C, Klingbiel D, Hitz F, Renner C, Pabst T, Driessen C, Mey U, Pless M, Bargetzi M, Krasniqi F, Gigli F, Hany T, Samarin A, Biaggi C, Rusterholz C, Dirnhofer S, Zucca E, Martinelli G. Final Results of a Prospective Evaluation of the Predictive Value of Interim Positron Emission Tomography in Patients With Diffuse Large B-Cell Lymphoma Treated With R-CHOP-14 (SAKK 38/07). J Clin Oncol. 2015 Aug 10;33(23):2523-9. doi: 10.1200/JCO.2014.58.9846. Epub 2015 Jul 6.

    PubMed 26150440

  • Tzankov A, Leu N, Muenst S, Juskevicius D, Klingbiel D, Mamot C, Dirnhofer S. Multiparameter analysis of homogeneously R-CHOP-treated diffuse large B cell lymphomas identifies CD5 and FOXP1 as relevant prognostic biomarkers: report of the prospective SAKK 38/07 study. J Hematol Oncol. 2015 Jun 14;8:70. doi: 10.1186/s13045-015-0168-7.

    PubMed 26071053

  • Mendeville MS, Janssen J, Los-de Vries GT, van Dijk E, Richter J, Nijland M, Roemer MGM, Stathi P, Hijmering NJ, Bladergroen R, Pelaz DA, Diepstra A, Eertink CJ, Burggraaff CN, Kim Y, Lugtenburg PJ, van den Berg A, Tzankov A, Dirnhofer S, Duhrsen U, Huttmann A, Klapper W, Zijlstra JM, Ylstra B, de Jong D. Integrating genetic subtypes with PET scan monitoring to predict outcome in diffuse large B-cell lymphoma. Nat Commun. 2025 Jan 2;16(1):109. doi: 10.1038/s41467-024-55614-y.

    PubMed 39747123

  • Ceriani L, Gritti G, Cascione L, Pirosa MC, Polino A, Ruberto T, Stathis A, Bruno A, Moccia AA, Giovanella L, Hayoz S, Schar S, Dirnhofer S, Rambaldi A, Martinelli G, Mamot C, Zucca E. SAKK38/07 study: integration of baseline metabolic heterogeneity and metabolic tumor volume in DLBCL prognostic model. Blood Adv. 2020 Mar 24;4(6):1082-1092. doi: 10.1182/bloodadvances.2019001201.

    PubMed 32196557

Questions about this trial

What is this clinical trial studying?

A study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Swiss Cancer Institute at 19 sites in 2 countries.

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 17 inclusion and 16 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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Switzerland, Italy. 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.

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?

Event-free survival (time frame: at 2 years). 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 NCT00544219, which also lists 5 linked publications.

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 15 May 2019.

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