RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas (RADCHOP)
Peripheral T Cell Lymphoma Unspecified, Anaplastic Large Cell Lymphoma, ALK-negative, Angioimmunoblastic T Cell Lymphoma
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma Unspecified focused on measuring RAD001, chemotherpy, T cell lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- National Cancer Center
- Samsung Medical Center
- Asan Medical Center
- Korea Cancer Center Hospital
- Yonsei Medical Center, Severance Hospital
Arms of the Study
Arm 1
Experimental
RAD001-CHOP
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