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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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

1. Primary objective

: To define the maximum tolerable dose

2. Secondary objective

• To evaluate the dose-limiting toxicity

• To evaluate the pharmacokinetics of RAD001

• Pharmacogenomic profiling

Phase II

1. Primary objective

: To evaluate the overall response rate

2. Secondary objective

• To estimate the time to progression

• To estimate overall survival

• Pharmacogenomic profiling

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Asan Medical Center; Korea Cancer Center Hospital; National Cancer Center, Korea; Yonsei University
• Treatments: Doxorubicin; Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus; Vincristine

Criteria

Inclusion Criteria:

1. 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

2. 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

3. At least one measurable lesion

4. ECOG PS 0-2

5. Informed consent

6. Age 20 to 70 years old

Exclusion Criteria:

1. Prior radiation therapy or surgery within 4 weeks prior to study entry

2. History of central nervous system (CNS) metastases

3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.

4. Pregnancy or breastfeeding.

5. Hepatitis B virus surface antigen positive

6. Extranodal NK/T cell lymphoma

7. Mycosis fungoides

8. ALK-positive Anaplastic large cell lymphoma