Study: NCT03003520

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: Durvalumab was supplied in single use vials as a liquid solution containing 500 mg (nominal) of durvalumab at a concentration of 50 mg/mL to be infused by intravenous (IV) injection.~Day 1 of each treatment cycle (Induction Period and Consolidation Period) started with the administration of IV durvalumab followed by a 2-hour observation period post infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: Durvalumab was supplied in single use vials as a liquid solution containing 500 mg (nominal) of durvalumab at a concentration of 50 mg/mL to be infused by intravenous (IV) injection.~Day 1 of each treatment cycle (Induction Period and Consolidation Period) started with the administration of IV durvalumab followed by a 2-hour observation period post infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Subsequent to durvalumab infusion, rituximab was administered by IV. Rituximab administration could be split over 2 consecutive days according to local clinical practice. Rapid infusion of rituximab was not allowed in this clinical study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Subsequent to durvalumab infusion, rituximab was administered by IV. Rituximab administration could be split over 2 consecutive days according to local clinical practice. Rapid infusion of rituximab was not allowed in this clinical study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone was administered as an IV infusion or by mouth (PO) on Day 1, followed by PO administration on Days 2-5 of each cycle.~Prednisone could be given prior to other drugs of the CHOP therapy. It was administered after lenalidomide dosing in the R2-CHOP treatment arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone was administered as an IV infusion or by mouth (PO) on Day 1, followed by PO administration on Days 2-5 of each cycle.~Prednisone could be given prior to other drugs of the CHOP therapy. It was administered after lenalidomide dosing in the R2-CHOP treatment arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: Lenalidomide was administered orally in capsule form on Days 1-14 of the DUR+R2-CHOP treatment arm only.