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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Peripheral T Cell Lymphoma UnspecifiedAnaplastic Large Cell Lymphoma, ALK-negativeAngioimmunoblastic T Cell LymphomaCutaneous T Cell Lymphoma
Interventions
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

Trial Locations (5)

135710

Samsung Medical Center, Seoul

Unknown

National Cancer Center, Goyang-si

Asan Medical Center, Seoul

Korea Cancer Center Hospital, Seoul

Yonsei Medical Center, Severance Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asan Medical Center

OTHER

collaborator

Yonsei University

OTHER

collaborator

National Cancer Center, Korea

OTHER_GOV

collaborator

Korea Cancer Center Hospital

OTHER

lead

Samsung Medical Center

OTHER

NCT01198665 - RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas | Biotech Hunter | Biotech Hunter