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CompletedNCT00544219Updated May 15, 2019

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

An interventional study of rituximab and cyclophosphamide in Lymphoma, sponsored by Swiss Group for Clinical Cancer Research. Completed at 19 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-15.

Sponsored by Swiss Group for Clinical Cancer Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 156 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • 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

    • 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

Exclusion criteria:

  • Secondary DLBCL (in transformation)
  • Evidence of symptomatic CNS disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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:

Exclusion criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
156 participants (actual)

Study arms

  • Other
    R-Chop 14

    Standard treatment

    Biological: rituximab · Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: prednisone · Drug: vincristine sulfate · Procedure: positron emission tomography

Interventions

  • Biologicalrituximab

    375 mg/m2 i.v. per cycle

    Also known as: Mabthera

  • Drugcyclophosphamide

    750 mg/m2 i.v. per cycle

    Also known as: Endoxan

  • Drugdoxorubicin hydrochloride

    50 mg/m2 i.v. per cycle

    Also known as: Adriamycin, Adriblastin

  • Drugprednisone

    100 mg/day p.o. per cycle

    Also known as: Deltasone, Orasone

  • Drugvincristine sulfate

    1.4 mg/m2 (max. 2.0 mg) i.v. per cycle

    Also known as: Oncovin

  • Procedurepositron emission tomography

    PET Scan during treatment

06

What researchers measure

Primary outcomes

  1. Event-free survival

    Time frame: at 2 years

Secondary outcomes

  1. Event-free survival

    Time frame: at 5 years

  2. Overall survival during follow-up

    Time frame: at 2 and 5 years

  3. Objective response

    Time frame: at 2 years

  4. Positron emission tomography (PET) results

    Time frame: at 2 years

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

    Time frame: at 2 years

07

Study locations

19 sites
  • European Institute of Oncology
    Milan, 20141, Italy
  • Hirslanden Klinik Aarau
    Aarau, CH-5001, Switzerland
  • Kantonspital Aarau
    Aarau, CH-5001, Switzerland
  • Kantonsspital Baden
    Baden, CH-5404, Switzerland
  • Praxis Dr. Streit
    Baden, CH-5404, Switzerland
  • Saint Claraspital AG
    Basel, CH-4016, Switzerland
  • Universitaetsspital-Basel
    Basel, CH-4031, Switzerland
  • Oncology Institute of Southern Switzerland
    Bellinzona, CH-6500, Switzerland
  • Inselspital Bern
    Bern, CH-3010, Switzerland
  • Kantonsspital Bruderholz
    Bruderholz, CH-4101, Switzerland
  • Kantonsspital Graubuenden
    Chur, CH-7000, Switzerland
  • Hopital Cantonal Universitaire de Geneve
    Geneva, CH-1211, Switzerland
  • Kantonsspital Liestal
    Liestal, CH-4410, Switzerland
  • Kantonsspital Olten
    Olten, CH-4600, Switzerland
  • Praxis Dr. Beretta
    Rheinfelden, CH-4310, Switzerland
  • Kantonsspital - St. Gallen
    St. Gallen, CH-9007, Switzerland
  • Regionalspital
    Thun, 3600, Switzerland
  • Kantonsspital Winterthur
    Winterthur, CH-8400, Switzerland
  • UniversitaetsSpital Zuerich
    Zurich, CH-8091, Switzerland
08

References and documents

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. Erratum In: J Clin Oncol. 2015 Sep 20;33(27):3074. doi: 10.1200/JCO.2015.64.3643. 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 ↗
  • 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. Erratum In: Blood Adv. 2020 May 26;4(10):2135. doi: 10.1182/bloodadvances.2020002200. PubMed 32196557 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00544219
Lead sponsor
Swiss Group for Clinical Cancer Research
Responsible party
Sponsor
First posted
Oct 16, 2007
Start date
Sep 2007
Primary completion
Sep 2012
Completion
Jan 2016
Last update
May 15, 2019

Study contacts

Christoph Mamot, MD
study chair · Kantonsspital Aarau
Mario Bargetzi, MD
study chair · Kantonsspital Aarau
Giovanni Martinelli, MD
study chair · European Institute of Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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