NCT00324467: LYTPET

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 2 Last updated 20 July 2021

What this trial tests

Phase 2 trial testing Cyclophosphamide in Lymphoma, Non-Hodgkin in 150 participants. Status unknown.

Timeline

1 August 2006

Primary endpoint
1 December 2021

1 December 2021

Quick facts

Lead sponsor	British Columbia Cancer Agency
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 August 2006
Primary completion	1 December 2021
Estimated completion	1 December 2021
Sites	1 location across Canada

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Doxorubicin
• Vincristine
• Prednisone (prednisone) — full drug profile →
• Ondansetron
• Dexamethasone (dexamethasone) — full drug profile →
• Diphenhydramine (diphenhydramine) — full drug profile →
• Acetaminophen
• Ifosfamide
• Mesna (IV)
• Mesna (oral)
• Carboplatin (Carboplatin) — full drug profile →
• Etoposide
• Rituximab
• Ondansetron
• Dexamethasone (dexamethasone) — full drug profile →
• Diphenhydramine (diphenhydramine) — full drug profile →
• Acetaminophen
• PET Scan

Conditions studied

• Lymphoma, Non-Hodgkin — all drugs for Lymphoma, Non-Hodgkin →
• Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma — all drugs for Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma →

Sponsor

British Columbia Cancer Agency

Who can join

18 and older, any sex, with Lymphoma, Non-Hodgkin or Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free survival (PFS) in participants with advanced stage DLBCL
  Time frame: Estimated two years
  Progression-free survival (PFS) in participants 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. Progression-free survival is defined as the duration of time from diagnosis to time of disease

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. FDG-PET/CT based response-adapted treatment.
   de Geus-Oei LF, Vriens D, Arens AI, Hutchings M, et al · · 2012 · cited 12× · PMID 23023063 · DOI 10.1102/1470-7330.2012.9006