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

Conditions

Lymphoma

Keywords

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

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.

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.

Mendeville MS, Janssen J, Los-de Vries GT, van Dijk E, Richter J, Nijland M, Roemer MGM, Stathi P, Hijmering NJ, Bladergroen R, Pelaz DA, Diepstra A, Eertink CJ, Burggraaff CN, Kim Y, Lugtenburg PJ, van den Berg A, Tzankov A, Dirnhofer S, Dührsen U, Hüttmann A, Klapper W, Zijlstra JM, Ylstra B, de Jong D.

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Interventions

BIOLOGICALrituximab

375 mg/m2 i.v. per cycle

DRUGcyclophosphamide

750 mg/m2 i.v. per cycle

DRUGdoxorubicin hydrochloride

50 mg/m2 i.v. per cycle

DRUGprednisone

100 mg/day p.o. per cycle

DRUGvincristine sulfate

1.4 mg/m2 (max. 2.0 mg) i.v. per cycle

PROCEDUREpositron emission tomography

PET Scan during treatment

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Event-free survival	at 2 years

Secondary

Measure	Time frame
Event-free survival	at 5 years
Overall survival during follow-up	at 2 and 5 years
Objective response	at 2 years
Positron emission tomography (PET) results	at 2 years
Histological results of remaining PET-positive lesion(s) after treatment	at 2 years

Countries

Italy, Switzerland

Outcome results

None listed