NCT02633137

Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma

Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, good and/or bad, the treatment including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on the participant and their lymphoma.

Detailed description

Patients will receive lenalidomide 15 mg orally daily on days 1-14 with standard-dose R-CHOP (375 mg/m\^2 intravenous rituximab, 750 mg/m2 intravenous cyclophosphamide, 50 mg/m\^2 intravenous doxorubicin, and 1.4 mg/m2 intravenous vincristine on day 1, and 100 mg prednisone days 1-5 or days 2-6) every 21 days for four cycles. All patients will receive pegfilgrastim on day 2 of each cycle and aspirin 81 mg orally daily for venous thromboembolism prophylaxis throughout the four cycles. After four cycles of Len-RCHOP, the patients will undergo restaging PET/CT scans. Patients with evidence of disease progression will be treated off study. R-HIDAC After lenalidomide-RCHOP phase, patients without evidence of progressive disease will receive rituximab 375 mg/m\^2 day 1 and then patients will be admitted for high-dose cytarabine (HIDAC). Recommended age-adjusted HIDAC doses are as follows: ≤65 years: 3 g/m2 every12 hours X 4 doses; 65-70 years: 2 g/m\^2 every12 hours X 4 doses; \>70 years: 1 g/m\^2 every12 hours X 4 doses. Physician discretion will dictate the choice of HIDAC dose, ranging from 1 g/m\^2 - 3 g/m\^2 every 12 hours X 4 doses. Patients will receive two cycles of rituximab-HIDAC every 3 weeks. After two cycles of R-HIDAC, the patients will undergo restaging PET/CT scans. Patients with evidence of disease progression will be treated off study. Len-Rituximab Maintenance After completion of induction chemotherapy with Len-RCHOP and R-HIDAC, patients will begin maintenance phase with lenalidomide and rituximab for 6 months. Lenalidomide will be administered at 15 mg orally daily on days 1-21 of a 28-day cycle for a total of 6 cycles and rituximab maintenance every 8 weeks for a total of 3 treatments.

Conditions

• Mantle Cell Lymphoma
• Untreated

Interventions

Type	Name	Description
DRUG	Lenalidomide
DRUG	R-CHOP	* Rituximab 375 mg/m\^2 IVPB with premedications Day 1 * Cyclophosphamide 750 mg/m\^2 IVPB Day 1 * Doxorubicin 50 mg/m\^2 IVP Day 1 * Vincristine 1.4 mg/m\^2 IVP (capped at 2 mg) Day 1 * Prednisone 100 mg PO Daily on Days 1-5 or 2-6
DRUG	high-dose cytarabine (HIDAC)

Timeline

• Start date: 2015-12-14
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2015-12-17
• Last updated: 2024-08-30
• Results posted: 2024-08-30

Locations

7 sites across 1 country: United States