NCT01198665

RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients. Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients. Phase I 1. Primary objective : To define the maximum tolerable dose 2. Secondary objective * To evaluate the dose-limiting toxicity * To evaluate the pharmacokinetics of RAD001 * Pharmacogenomic profiling Phase II 1. Primary objective : To evaluate the overall response rate 2. Secondary objective * To estimate the time to progression * To estimate overall survival * Pharmacogenomic profiling

Detailed description

Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression

Conditions

• Peripheral T Cell Lymphoma Unspecified
• Anaplastic Large Cell Lymphoma, ALK-negative
• Angioimmunoblastic T Cell Lymphoma
• Cutaneous T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	RAD001 (Everolimus)	Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-09-10
• Last updated: 2015-03-03

Locations

5 sites across 1 country: South Korea