NCT01198665|CompletedPhase 1/2DMC
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
RADCHOP
A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
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Sponsor study identifier
interventional
46
1 country
5
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2010
Actual (reported)September 10, 2010
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)determination of the maximum tolerable dose and evaluation of response rate
Phase I for maximal tolerable dose and phase II for efficacy
doe-limiting toxicity and pharmacogenomics
Phase I/II
Prospective multicenter open-label phase I/II study Phase I: RAD001 2.5 - 10 mg PO daily D1-14 + CHOP every 3 weeks Phase II: Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Cancer Center
Goyang-si, Kyoungki-do, South Korea
Samsung Medical Center
Seoul, 135710, South Korea
Asan Medical Center
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
Yonsei Medical Center, Severance Hospital
Seoul, South Korea
Banchi M, Cox MC, Bandini A, Orlandi P, Tacchi C, Stefanelli F, Chericoni S, Bocci G. Linifanib alone and in combination with metronomic chemotherapy is active on cutaneous T-cell lymphoma cells by targeting the AKT/mTOR signaling pathway. Invest New Drugs. 2025 Feb;43(1):135-146. doi: 10.1007/s10637-024-01501-8. Epub 2025 Jan 17.
Won Seog Kim, MD, PhD
Samsung Medical Center
46 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2010
First Posted
September 10, 2010
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
March 3, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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