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

NCT ID: NCT00324467

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed Description

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.

Conditions

Lymphoma, Non-Hodgkin; Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP (Negative Mid-Treatment PET Scan)

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a negative mid-treatment PET scan (no evidence of abnormal 18F-FDG uptake) will complete therapy with two additional cycles of R-CHOP for a total of 6 cycles of chemotherapy. Patients with a mid-treatment PET scan interpreted to be "indeterminate" or "equivocal" will be recorded as such, but should be considered negative for the purpose of treatment planning and should not prompt a change in therapy.

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type: DRUG

Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Doxorubicin

Intervention Type: DRUG

Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Vincristine

Intervention Type: DRUG

Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Prednisone

Intervention Type: DRUG

Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Ondansetron

Intervention Type: DRUG

Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Dexamethasone

Intervention Type: DRUG

Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Diphenhydramine

Intervention Type: DRUG

Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Acetaminophen

Intervention Type: DRUG

Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

PET Scan

Intervention Type: OTHER

Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)

R-ICE (Positive Mid-Treatment PET Scan

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a mid-treatment PET scan (abnormal 18F-FDG uptake) will be switched to R-ICE chemotherapy and receive 4 cycles of R-ICE for a total of 8 cycles of chemotherapy.

Following completion of R-ICE chemotherapy, patients will undergo a post-treatment PET scan along with routine restaging investigations. The post-treatment PET scan will be performed between days 28 and 35 following the final cycle of R-ICE. Patients with a negative post-treatment PET scan will undergo no further therapy. Patients with a positive post-treatment PET scan corresponding to persistent abnormalities on CT scan will be considered for radiation therapy to PET positive sites.

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type: DRUG

Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Doxorubicin

Intervention Type: DRUG

Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Vincristine

Intervention Type: DRUG

Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Prednisone

Intervention Type: DRUG

Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Ondansetron

Intervention Type: DRUG

Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Dexamethasone

Intervention Type: DRUG

Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Diphenhydramine

Intervention Type: DRUG

Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Acetaminophen

Intervention Type: DRUG

Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Ifosfamide

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m\^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3, over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Mesna (IV)

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m\^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3 (with ifosfamide) over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Mesna (oral)

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 2 g Administration: PO 2h and 4h after ifosfamide infusion on days 1,2,3 Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Carboplatin

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5 x (25+CrCl*) (maximum dose 800 mg) Administration: IV infusion day 1 over 1 hour Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

*Carboplatin is dose via the Calvert formula with an AUC of 5, maximum dose 800 mg per cycle.

Estimate Creatinine Clearance (CrCl)

Etoposide

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 100 mg/m\^2 Administration: IV infusion day 1,2,3 over 30 minutes Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Rituximab

Intervention Type: DRUG

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 375 mg/m\^2 Administration: IV infusion day 1 (or day 2 or day 3) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Ondansetron

Intervention Type: DRUG

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Dexamethasone

Intervention Type: DRUG

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Diphenhydramine

Intervention Type: DRUG

Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Acetaminophen

Intervention Type: DRUG

Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

PET Scan

Intervention Type: OTHER

Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)

Interventions

Cyclophosphamide

Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type: DRUG

Doxorubicin

Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type: DRUG

Vincristine

Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type: DRUG

Prednisone

Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)

• Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type: DRUG

Ondansetron

Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Intervention Type: DRUG

Dexamethasone

Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Intervention Type: DRUG

Diphenhydramine

Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type: DRUG

Acetaminophen

Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type: DRUG

Ifosfamide

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m\^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3, over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type: DRUG

Mesna (IV)

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m\^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3 (with ifosfamide) over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type: DRUG

Mesna (oral)

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 2 g Administration: PO 2h and 4h after ifosfamide infusion on days 1,2,3 Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type: DRUG

Carboplatin

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5 x (25+CrCl*) (maximum dose 800 mg) Administration: IV infusion day 1 over 1 hour Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

*Carboplatin is dose via the Calvert formula with an AUC of 5, maximum dose 800 mg per cycle.

Estimate Creatinine Clearance (CrCl)

Intervention Type: DRUG

Etoposide

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 100 mg/m\^2 Administration: IV infusion day 1,2,3 over 30 minutes Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type: DRUG

Rituximab

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 375 mg/m\^2 Administration: IV infusion day 1 (or day 2 or day 3) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type: DRUG

Ondansetron

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Intervention Type: DRUG

Dexamethasone

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Intervention Type: DRUG

Diphenhydramine

Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type: DRUG

Acetaminophen

Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type: DRUG

PET Scan

Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)

Intervention Type: OTHER

Other Intervention Names

Cytoxan®, Neosar®; Adriamycin ®, Rubex®; Oncovin ®, Vincasar Pfs ®, Vincristine Sulfate, LCR, VCR; Sterapred®, Sterapred® DS, Prednisone Intensol; Zofran®, Zofran® ODT, Zuplenz®; Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®; Aler-Dryl®, Benadryl®, Nytol®, Diphenhist®; Tylenol®; Ifex®, Isophosphamide; Mesnex®, Sodium 2-mercaptoethanesulfonate; Mesnex®, Sodium 2-mercaptoethanesulfonate; CBDCA; Etopophos®, VP-16; Rituxan®; Zofran®, Zofran® ODT, Zuplenz®; Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®; Aler-Dryl®, Benadryl®, Nytol®, Diphenhist®; Tylenol®; Positron emission tomography (PET) scan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie H Sehn, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer Agency - Vancouver Centre

Locations

BC Cancer Agency

Vancouver, British Columbia, Canada

Countries

Canada

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Other Identifiers

H06-00017

Identifier Type: -

Identifier Source: org_study_id