CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,073 enrolled
Drug / intervention
(R-)CHOP protocol +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00554164
NCT00554164Phase 3Completed

Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas

University Hospital, Essen·interventional·Posted Nov 6, 2007·Updated May 5, 2017

In Brief

A Phase 3 clinical trial evaluating (R-)CHOP protocol and B-ALL protocol for Lymphoma, High-grade. Completed, enrolled 1,073 participants across 1 site.

Detailed Summary

The main purpose of the PETAL trial is to determine whether patients with aggressive non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of chemotherapy benefit from a change of the treatment protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 18.7 years ago

Interventions

(R-)CHOP protocoldrug

Patients with a persistently positive interim-PET scan assigned to arm B1 will receive another six cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone).

B-ALL protocoldrug

Patients with a persistently positive interim-PET scan assigned to arm B2 will receive six blocks of the B-ALL protocol (rituximab, methotrexate, ifosfamide, etoposide, cytarabine, vincristine, cyclophosphamide, doxorubicine, vindesine, dexamethasone).

(R-)CHOP protocoldrug

Patients with a negative interim-PET scan assigned to arm A1 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone). Arm A1 was closed when the number of patients required for the randomisation between arms A1 and A2 was reached.

(R-)CHOP protocoldrug

Patients with a negative interim-PET scan assigned to arm A2 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) plus two additional doses rituximab. Since the number of patients required for the randomisation between arms A1 and A2 has been reached, all patients with a negative interim-PET scan are treated according to arm A2.