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
1 other identifier
interventional
46
1 country
5
Brief 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
- To evaluate the dose-limiting toxicity
- To evaluate the pharmacokinetics of RAD001
- Pharmacogenomic profiling Phase II
- Primary objective
- Secondary objective
- To estimate the time to progression
- To estimate overall survival
- Pharmacogenomic profiling
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2010
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 3, 2015
March 1, 2015
4.4 years
September 8, 2010
March 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
determination of the maximum tolerable dose and evaluation of response rate
Phase I for maximal tolerable dose and phase II for efficacy
Secondary Outcomes (1)
doe-limiting toxicity and pharmacogenomics
Phase I/II
Study Arms (1)
RAD001-CHOP
EXPERIMENTALProspective 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma (AITL), Cutaneous T-cell lymphoma
- Adequate organ function as defined by the following criteria:
- A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B.Total serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets ≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN
- At least one measurable lesion
- ECOG PS 0-2
- Informed consent
- Age 20 to 70 years old
You may not qualify if:
- Prior radiation therapy or surgery within 4 weeks prior to study entry
- History of central nervous system (CNS) metastases
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
- Pregnancy or breastfeeding.
- Hepatitis B virus surface antigen positive
- Extranodal NK/T cell lymphoma
- Mycosis fungoides
- ALK-positive Anaplastic large cell lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Asan Medical Centercollaborator
- Yonsei Universitycollaborator
- National Cancer Center, Koreacollaborator
- Korea Cancer Center Hospitalcollaborator
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Seog Kim, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 10, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 3, 2015
Record last verified: 2015-03