Early Stage Follicular LymphOma and RadioTherapy PLUS anti-CD20 Antibody

Conditions

Early Stage Follicular LymphOma

Brief summary

Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)

Detailed description

Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI, Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed), Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start), PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start), Toxicity (NCI-CTC criteria, version 5) of all patients, Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits., Overall survival (OS) of each treatment arm (2 years), Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)

Related papers

No related papers found yet.

Interventions

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

DRUGMabThera 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)	—

Secondary

Measure	Time frame
Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI, Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed), Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start), PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start), Toxicity (NCI-CTC criteria, version 5) of all patients, Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits., Overall survival (OS) of each treatment arm (2 years), Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)	—

Measure

Time frame

Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI, Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed), Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start), PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start), Toxicity (NCI-CTC criteria, version 5) of all patients, Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits., Overall survival (OS) of each treatment arm (2 years), Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)

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Countries

Germany

Outcome results

None listed