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NCT Number: NCT01198665

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

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

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Key information

Conditions

Peripheral T Cell Lymphoma Unspecified Anaplastic Large Cell Lymphoma, ALK-negative Angioimmunoblastic T Cell Lymphoma Cutaneous T Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center, Goyang-si, Kyoungki-do, South Korea

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About this study

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 Treatment will be continued until planned 6 cycles or disease progression

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAD001 (Everolimus)

Drug

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

Other names: Cytoxan, Doxorubicin, Vincristine, prednisolone

Primary outcomes

  1. determination of the maximum tolerable dose and evaluation of response rate

    Time frame: Phase I for maximal tolerable dose and phase II for efficacy

Secondary outcomes

  1. doe-limiting toxicity and pharmacogenomics

    Time frame: Phase I/II

    Phase I

    • To evaluate the dose-limiting toxicity
    • To evaluate the pharmacokinetics of RAD001
    • Pharmacogenomic profiling Phase II
    • To estimate the time to progression
    • To estimate overall survival
    • Pharmacogenomic profiling

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Asan Medical Center
  • Korea Cancer Center Hospital
  • National Cancer Center, Korea
  • Yonsei University

Registry information

Official study title

A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

Acronym: RADCHOP

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2010
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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