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Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin, Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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Trial Information

Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results


This is a phase II trial investigating tailoring first-line therapy for advanced stage
diffuse large B-cell NHL (DLBCL) based on a mid-treatment 18F-FDG- positron-emission
tomography (PET) scan result. More than half of all patients with DLBCL can be cured with
6-8 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,
prednisone). Patients who are not cured with R-CHOP have a very poor prognosis. This study
will assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment
PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE
(rituximab, ifosfamide, carboplatin, etoposide).

Objectives:

- To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET
scan result for patients with advanced stage DLBCL.

- To assess the progression-free survival (PFS) in patients with advanced stage DLBCL who
have a negative mid-treatment PET scan and receive standard therapy with six cycles of
CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of
CHOP-R followed by four cycles of R-ICE chemotherapy.

- To assess the overall survival (OS) in patients with advanced stage DLBCL who have a
negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R
and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R
followed by four cycles of R-ICE chemotherapy.


Inclusion Criteria:



- 18 years of age or older

- newly diagnosed histologically proven CD-20 positive diffuse large B- cell lymphoma
by tissue biopsy, listed under peripheral B-cell neoplasm according to the WHO/REAL
classification (diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma,
T-cell rich B-cell lymphoma, intravascular large B-cell lymphoma)

- Advanced stage disease defined as - patients with stage III or stage IV disease; or
patients with stage I or stage II disease with one of the following additional
criteria: B-symptoms, or disease that is not radio- encompassable within a single
involved field, or not a candidate for brief chemotherapy and irradiation, or the
presence of bulky disease (any single mass => 10 cm)

- Previously untreated or treated with up to 3 cycles of standard dose 3- weekly R-CHOP
chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation
of the fourth cycle of R-CHOP chemotherapy)

- ECOG Performance Status 0,1 or 2 at time of enrollment

- No evidence of progressive disease while on R-CHOP chemotherapy

- The patient must sign the consent form prior to registration

Exclusion Criteria:

- Patients with a history of any other lymphoproliferative disorder, including prior
history of indolent NHL

- Patients with a history of prior or concurrent malignancies within 5 years of the
current diagnosis, except adequately treated non- melanoma skin cancer, and
curatively treated in-situ cancer of the cervix

- Known HIV infection

- Known hepatitis B virus infection

- Pregnancy or lactation. Men and women of childbearing age must be using adequate
contraception.

- Significant renal insufficiency (serum creatinine > 200 mmol/L), unless due to
lymphoma

- Significant hepatic insufficiency (serum total bilirubin > 30 mmol/L), unless due to
lymphoma

- Cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on
echocardiography). If history of cardiac disease, ejection fraction must be within
normal limits for age.

- Neurologic contraindication to vincristine (e.g. peripheral neuropathy)

- Absolute neutrophil count <1.5 x 109/L (unless due to bone marrow involvement with
lymphoma or due to initiation of R-CHOP chemotherapy)

- Platelet count < 100 x 109/L (unless due to splenomegaly, bone marrow involvement
with lymphoma or due to initiation of R-CHOP chemotherapy)

- Evidence of active systemic infection

- Any medical condition that in the opinion of the investigator would compromise
treatment delivery, add toxicity or impair assessment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

efficacy

Principal Investigator

Laurie Sehn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency - Vancouver Centre

Authority:

Canada: Health Canada

Study ID:

PET in DLBCL

NCT ID:

NCT00324467

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma
  • NON-HODGKIN'S LYMPHOMA
  • POSITRON EMISSION TOMOGRAPHY
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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