Trials / Unknown
UnknownNCT00324467
Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- British Columbia Cancer Agency · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
| 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 |
| 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 |
| 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 |
| DRUG | Ondansetron | Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy |
| DRUG | Dexamethasone | Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy |
| DRUG | Diphenhydramine | Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion |
| DRUG | Acetaminophen | Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| DRUG | Ondansetron | Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily |
| DRUG | Dexamethasone | Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily |
| DRUG | Diphenhydramine | Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion |
| DRUG | Acetaminophen | Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion |
| OTHER | 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) |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2006-05-11
- Last updated
- 2021-07-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00324467. Inclusion in this directory is not an endorsement.