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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01198665
Other study ID # 2010-01-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 8, 2010
Last updated March 1, 2015
Start date July 2010
Est. completion date December 2014

Study information

Verified date March 2015
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of National Cancer Center Goyang-si Kyoungki-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea Cancer Center Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Yonsei Medical Center, Severance Hospital Seoul

Sponsors (5)

Lead Sponsor Collaborator
Samsung Medical Center Asan Medical Center, Korea Cancer Center Hospital, National Cancer Center, Korea, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary determination of the maximum tolerable dose and evaluation of response rate Phase I for maximal tolerable dose and phase II for efficacy Yes
Secondary doe-limiting toxicity and pharmacogenomics 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
Phase I/II Yes
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