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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00544219
First received: October 13, 2007
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
  • Overall survival during follow-up [ Time Frame: at 2 and 5 years ] [ Designated as safety issue: No ]
  • Objective response [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Positron emission tomography (PET) results [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Histological results of remaining PET-positive lesion(s) after treatment [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: September 2007
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544219

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Switzerland
Kantonspital Aarau
Aarau, Switzerland, CH-5001
Hirslanden Klinik Aarau
Aarau, Switzerland, CH-5001
Praxis Dr. Streit
Baden, Switzerland, CH-5404
Kantonsspital Baden
Baden, Switzerland, CH-5404
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Saint Claraspital AG
Basel, Switzerland, CH-4016
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital Olten
Olten, Switzerland, CH-4600
Praxis Dr. Beretta
Rheinfelden, Switzerland, CH-4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Christoph Mamot, MD Kantonsspital Aarau
Study Chair: Mario Bargetzi, MD Kantonsspital Aarau
Study Chair: Giovanni Martinelli, MD European Institute of Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00544219     History of Changes
Other Study ID Numbers: SAKK 38/07, SWS-SAKK-38-07, EU-20763, EUDRACT-2007-001806-26, CDR0000569869
Study First Received: October 13, 2007
Last Updated: December 8, 2013
Health Authority: Switzerland: Swissmedic
Switzerland: Federal Office of Public Health

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:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on October 22, 2014