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

This study is currently recruiting participants.
Verified January 2013 by Samsung Medical Center
Sponsor:
Collaborators:
Asan Medical Center
Yonsei University
National Cancer Center, Korea
Korea Cancer Center Hospital
Information provided by (Responsible Party):
Kim, Seok Jin, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01198665
First received: September 8, 2010
Last updated: January 12, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Peripheral T Cell Lymphoma Unspecified
Anaplastic Large Cell Lymphoma, ALK-negative
Angioimmunoblastic T Cell Lymphoma
Cutaneous T Cell Lymphoma
 Drug: RAD001 (Everolimus)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • determination of the maximum tolerable dose and evaluation of response rate [ Time Frame: Phase I for maximal tolerable dose and phase II for efficacy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • doe-limiting toxicity and pharmacogenomics [ Time Frame: Phase I/II ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 46
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
Other Name: Cytoxan, Doxorubicin, Vincristine, prednisolone

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 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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198665

Contacts
Contact: Seok Jin Kim, MD, PHD 82234101766 kstwoh@skku.edu

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Kyoungki-do, Korea, Republic of
Contact: Hyeon Seok Eom, MD, PhD            
Principal Investigator: Hyeon Seok Eom, MD, PhD            
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135710
Contact: Won Seog Kim, MD PhD     82234106548     wskimsmc@skku.edu    
Principal Investigator: Won Seog Kim, MD, PhD            
Sub-Investigator: Seok Jin Kim, MD, PhD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Cheolwon Suh, MD, PhD            
Principal Investigator: Cheolwon Suh, MD, PhD            
Yonsei Medical Center, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Seok Kim, MD            
Principal Investigator: Jin Seok Kim, MD            
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hye Jin Kang, MD            
Principal Investigator: Hye Jin Kang, MD            
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
Yonsei University
National Cancer Center, Korea
Korea Cancer Center Hospital
Investigators
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kim, Seok Jin, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01198665     History of Changes
Other Study ID Numbers: 2010-01-001
Study First Received: September 8, 2010
Last Updated: January 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
RAD001
chemotherpy
T cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Immunoblastic Lymphadenopathy
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Sirolimus
 Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 16, 2013