Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to 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).

Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis (>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP. Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis (~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: Hoffmann-La Roche
• Treatments: Acetaminophen; BB 1101; Carboplatin; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphenhydramine; Doxorubicin; Etoposide; Ifosfamide; Isophosphamide mustard; Mesna; Ondansetron; Prednisone; Promethazine; Rituximab; Vincristine

Criteria

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