PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
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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 |
- Event-free survival [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
- 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 |
Estimated 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Italy | |
European Institute of Oncology | |
Milan, Italy, 20141 | |
Switzerland | |
Hirslanden Klinik Aarau | |
Aarau, Switzerland, CH-5001 | |
Kantonspital Aarau | |
Aarau, Switzerland, CH-5001 | |
Kantonsspital Baden | |
Baden, Switzerland, CH-5404 | |
Praxis Dr. Streit | |
Baden, Switzerland, CH-5404 | |
Saint Claraspital AG | |
Basel, Switzerland, CH-4016 | |
Universitaetsspital-Basel | |
Basel, Switzerland, CH-4031 | |
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 |
Study Chair: | Christoph Mamot, MD | Kantonsspital Aarau |
Study Chair: | Mario Bargetzi, MD | Kantonsspital Aarau |
Study Chair: | Giovanni Martinelli, MD | European Institute of Oncology |
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: | June 29, 2012 |
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on October 17, 2012