A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination with Rituximab in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma

Conditions

Newly Diagnosed Advanced Stage Follicular Lymphoma

Brief summary

To evaluate if the patient´s condition improves using CMR. This means that at different times during the treatment, such as 6 months or 12 months after the start of treatment, the person's disease has completely responded to the treatment.

Detailed description

To evaluate any negative side effects or adverse events (AE), which means an occurrence that has a negative impact on the health or well-being of a participant. This includes any new side effects that start after the treatment begins, which we call "Treatment-Emergent Adverse Events" (TEAEs)., To evaluate all AE, including TEAE and laboratory test as well as CMR data collected during the treatment of the Golcadomide and rituximab combination., To evaluate the overall response rate (ORR), the percentage of participants whose cancer shrinks or disappears., To evaluate PFS, the time from when we start the treatment until the disease gets worse or the patient passes away., To evaluate OS, which is the time from when we start the treatment until the patient passes away., To evaluate all AE, including TEAE and laboratory test as well as CMR, ORR, PFS and OS data collected during the treatment of the rituximab and chemotherapy combination.

Related papers

No related papers found yet.

Interventions

DRUGCYCLOPHOSPHAMIDE

DRUGPREDNISOLONE

DRUGGolcadomide

DRUGVINCRISTINE SULFATE

DRUGPEGFILGRASTIM

DRUGRITUXIMAB

DRUGDOXORUBICIN

DRUGPREDNISONE

DRUGBENDAMUSTINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate if the patient´s condition improves using CMR. This means that at different times during the treatment, such as 6 months or 12 months after the start of treatment, the person's disease has completely responded to the treatment.	—

Secondary

Measure	Time frame
To evaluate any negative side effects or adverse events (AE), which means an occurrence that has a negative impact on the health or well-being of a participant. This includes any new side effects that start after the treatment begins, which we call "Treatment-Emergent Adverse Events" (TEAEs)., To evaluate all AE, including TEAE and laboratory test as well as CMR data collected during the treatment of the Golcadomide and rituximab combination., To evaluate the overall response rate (ORR), the percentage of participants whose cancer shrinks or disappears., To evaluate PFS, the time from when we start the treatment until the disease gets worse or the patient passes away., To evaluate OS, which is the time from when we start the treatment until the patient passes away., To evaluate all AE, including TEAE and laboratory test as well as CMR, ORR, PFS and OS data collected during the treatment of the rituximab and chemotherapy combination.	—

Measure

Time frame

To evaluate any negative side effects or adverse events (AE), which means an occurrence that has a negative impact on the health or well-being of a participant. This includes any new side effects that start after the treatment begins, which we call "Treatment-Emergent Adverse Events" (TEAEs)., To evaluate all AE, including TEAE and laboratory test as well as CMR data collected during the treatment of the Golcadomide and rituximab combination., To evaluate the overall response rate (ORR), the percentage of participants whose cancer shrinks or disappears., To evaluate PFS, the time from when we start the treatment until the disease gets worse or the patient passes away., To evaluate OS, which is the time from when we start the treatment until the patient passes away., To evaluate all AE, including TEAE and laboratory test as well as CMR, ORR, PFS and OS data collected during the treatment of the rituximab and chemotherapy combination.

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Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed