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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

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