Status:
COMPLETED
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Asan Medical Center
Yonsei University
Conditions:
Peripheral T Cell Lymphoma Unspecified
Anaplastic Large Cell Lymphoma, ALK-negative
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
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 RA...
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 we...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01198665
Start Date
July 1 2010
End Date
December 1 2014
Last Update
March 3 2015
Active Locations (5)
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1
National Cancer Center
Goyang-si, Kyoungki-do, South Korea
2
Samsung Medical Center
Seoul, South Korea, 135710
3
Asan Medical Center
Seoul, South Korea
4
Korea Cancer Center Hospital
Seoul, South Korea