Know Cancer

forgot password

Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study

18 Years
80 Years
Open (Enrolling)

Thank you

Trial Information

Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study



- 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.


- To compare modified PET/CT scan response criteria with revised standard response

- 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)

After completion of study treatment, patients are followed periodically for up to 5 years.

Inclusion Criteria


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


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


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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

at 2 years

Safety Issue:


Principal Investigator

Christoph Mamot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital Aarau


Switzerland: Swissmedic

Study ID:

SAKK 38/07



Start Date:

September 2007

Completion Date:

September 2015

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse