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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544219
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 15, 2019
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Procedure: positron emission tomography Not Applicable

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2016

Arm Intervention/treatment
R-Chop 14
Standard treatment
Biological: rituximab
375 mg/m2 i.v. per cycle
Other Name: Mabthera

Drug: cyclophosphamide
750 mg/m2 i.v. per cycle
Other Name: Endoxan

Drug: doxorubicin hydrochloride
50 mg/m2 i.v. per cycle
Other Name: Adriamycin, Adriblastin

Drug: prednisone
100 mg/day p.o. per cycle
Other Name: Deltasone, Orasone

Drug: vincristine sulfate
1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
Other Name: Oncovin

Procedure: positron emission tomography
PET Scan during treatment

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544219

Show Show 19 study locations
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Christoph Mamot, MD Kantonsspital Aarau
Study Chair: Mario Bargetzi, MD Kantonsspital Aarau
Study Chair: Giovanni Martinelli, MD European Institute of Oncology
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00544219    
Other Study ID Numbers: SAKK 38/07
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Keywords provided by Swiss Group for Clinical Cancer Research:
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
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors