A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients

NCT ID: NCT01788137

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2017-12-31

Brief Summary

This is a prospective , open, multicenter, randomized phase III study. The investigators planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.

Detailed Description

This is a prospective , open, multicenter, randomized phase III study. We planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.

• randomization Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study.
• Dosage and administration

• Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles.
• Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.

patients with bulky disease or extranodal lesion wil be received radiotherapy after finishing the chemotherapy.

• Study evaluations

• Criteria for response categories Tumour response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas(1998)
• Efficacy Criteria Disease-free survival Disease-free survival for patients in CR or CRu is measured from the first assessment that documents that response to the date of disease progression or the most recent follow-up visit time. Response rate Response rate is defined as the proportion of subjects who achieve CR/Cru and PR relative to the total population.Overall survival Overall survival is measured from entry onto the study until death from any cause, or the most recent follow-up visit date
• Scheduling of tumour assessments Baseline total tumour burden must be assessed within a maximum of 21 days before first dose of treatment.Follow-up tumour evaluations will be performed during the last week of every 3rd cycle. After finishing the therapies, tumor evaluation will be performed every 3 months in the first and second years,following every 6 months after 2years. tumour assessments may be performed by CT/MRI for the internal organs lesion. In case of clinically measurable superficial lesions, accurate evidence should be performed in the original records.
• Clinical Safety Assessments

The following, safety, assessments and procedures will be performed according to the schedule of assessments:

• A complete medical history (including demographics, smoking history, cancer/treatment history) will be performed at screening.
• Physical examination*
• ECG
• Weight
• Blood pressure
• heart rate
• respiratory rate
• ECOG Score
• Infection signs Adverse Events and Serious Adverse Events (SAEs) reported according to NCI-CTC criteria. Patients will be assessed for adverse events at each clinical visit and as necessary throughout the study.

• Laboratory Safety Assessments

The following will be completed according to the schedule of assessments:

• Hæmoglobin
• Haematocrit
• Leucocytes
• Neutrophils
• Platelets
• Serum electrolytes ( K+, Ca++)
• Serum chemistries (Total bilirubin, ALT [SGPT], AST [SGOT], total protein, albumin, LDH, alkaline phosphatase, urea [BUN], serum creatinine, creatinine clearance).
• Dipstick urinalysis. In case of a significant finding, a microscopic urinalysis should be performed.

Note:Adverse Events and Serious Adverse Events (SAEs) reported according to NCI-CTC criteria(Version 3.0)Patients will be assessed for adverse events at each clinical visit and as necessary throughout the study.

• Follow-up Patients on the study should be reassessed after completion of treatment at a minimum of every 3 months for 2 years, then every 6 months until the completion of the study.assessment content at follow-up visits should include history, physical examination ,blood picture, Urinalysis,liver and kidney function and tumor assessments.
• Statistical analyzes The proposed regimen was to be considered worthy for additional investigation in this patient population if a disease control rate of 15% or greater. The total sample size will be about 368 patients (to collect 380 evaluable patients, considering a drop-out rate of around 10%,each group number: 190). Treatment duration was defined as days from the first day of drug administration to the last regulated rest day of the final cycle.,Primary objective is overall survival d. Secondary objectives are response rate, safety and disease free survival Response rate is estimated using the binomial probability and exact 95% confidence intervals (CIs) were provided. disease free survival and overall survival curves are estimated using Kaplan-Meier methodology.

Adverse events and laboratory tests graded according to the NCI-CTC AE(Version 3).Adverse events will be assigned preferred terms and categorized into body systems according to the MEDDRA classification of the WHO terminology

Conditions

T-cell Lymphoma Adults; Previously Untreated; High Risk

Keywords

T-cell lymphoma,DFS,OS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHOP

CHOP regimen Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles.

Group Type: ACTIVE_COMPARATOR

chemotherapy (CHOP)

Intervention Type: DRUG

Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles

c-ATT regimen

c-ATT regimen Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.

Group Type: ACTIVE_COMPARATOR

chemotherapy(c-ATT)

Intervention Type: DRUG

Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.

Interventions

chemotherapy (CHOP)

Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles

Intervention Type: DRUG

chemotherapy(c-ATT)

Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.

Intervention Type: DRUG

Other Intervention Names

CHOP; c-ATT

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and ≤70 years old.
• Histological documented high risk T cell lymphoma:extranodal NK/T-cell lymphoma,hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma,angioimmunoblastic T-cell lymphoma,enteropathy-type T-cell lymphoma, peripheral T-cell lymphoma,unspecified.
• Measurable disease and evaluable lesion.
• Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.
• Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L)
• ECOG Performance status 0-3,Life expectancy of at least 3 months.
• Without history of another malignancy
• Without any conflict serious systemic disease
• Without any accompany treatment(including steroids drugs)
• Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening.

Exclusion Criteria

• Patients with prior clinical study within 3 months.
• Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy
• Transformed lymphoma
• Mycosis fungicide/Sézary syndrome（MF/SS）
• History of allergic reaction to any ectogenic proteins
• Prior treatment for lymphoma .
• History of another malignancy
• Neutrophil count < 1.0× 109/L ,hemoglobin < 90g/L,platelets < 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection.
• Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months
• Serious infective or organic disease
• Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal)
• liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl)
• clinical syndrome of encephalon functional disorder,serious psychosis
• female subject who is pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Tongyu Lin

vice chairman of department of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guan ZhongZhen

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Tumor center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guan ZhongZhen

Role: CONTACT

Phone: 86-20-87343356

Email: tongyulin@hotmail.com

Cheng-cheng Guo

Role: CONTACT

Phone: 86-20-87343565

Email: guochch@sysucc.org.cn

Facility Contacts

Guan ZhongZhen

Role: primary

Other Identifiers

CSWOG0002

Identifier Type: -

Identifier Source: org_study_id