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

May 13, 2019 updated by: Swiss Group for Clinical Cancer Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: R-Chop 14
Standard treatment
Biological: rituximab
375 mg/m2 i.v. per cycle
Other Names:
  • Mabthera
Drug: cyclophosphamide
750 mg/m2 i.v. per cycle
Other Names:
  • Endoxan
Drug: doxorubicin hydrochloride
50 mg/m2 i.v. per cycle
Other Names:
  • Adriamycin, Adriblastin
Drug: prednisone
100 mg/day p.o. per cycle
Other Names:
  • Deltasone, Orasone
Drug: vincristine sulfate
1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
Other Names:
  • Oncovin
Procedure: positron emission tomography
PET Scan during treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Event-free survival
Time Frame: at 2 years
at 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Event-free survival
Time Frame: at 5 years
at 5 years
Overall survival during follow-up
Time Frame: at 2 and 5 years
at 2 and 5 years
Objective response
Time Frame: at 2 years
at 2 years
Positron emission tomography (PET) results
Time Frame: at 2 years
at 2 years
Histological results of remaining PET-positive lesion(s) after treatment
Time Frame: at 2 years
at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Group for Clinical Cancer Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Christoph Mamot, MD, Kantonsspital Aarau
  • Study Chair: Mario Bargetzi, MD, Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAKK 38/07
  • SWS-SAKK-38-07
  • EU-20763
  • EUDRACT-2007-001806-26
  • CDR0000569869

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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