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

NCT01198665 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2015-03-03

No results posted yet for this study

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

Conditions

  • Peripheral T Cell Lymphoma Unspecified
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • Angioimmunoblastic T Cell Lymphoma
  • Cutaneous T Cell Lymphoma

Interventions

DRUG

RAD001 (Everolimus)

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

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Yonsei University

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Korea Cancer Center Hospital

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won Seog Kim, MD, PhD · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198665 on ClinicalTrials.gov