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

NCT01788137 | Unknown Phase 3 DMC

• 1 other identifier: CSWOG0002
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

T-cell Lymphoma Adults; Previously Untreated; High Risk

Keywords

T-cell lymphoma,DFS,OS

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

  5-year

Secondary Outcomes (7)

• DFS

  5-year

• RR rate

  5year

• CR rate

  5year

• PR rate

  5year

• progression of disease rate

  5year

Study Arms (2)

CHOP

ACTIVE COMPARATOR

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.

Drug: chemotherapy (CHOP)

c-ATT regimen

ACTIVE COMPARATOR

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.

Drug: chemotherapy(c-ATT)

Interventions

chemotherapy (CHOP) 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

Also known as: CHOP

CHOP

chemotherapy(c-ATT) 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.

Also known as: c-ATT

c-ATT regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese Academy of Medical Sciences: collaborator
• Fudan University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Tumor center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Guan ZhongZhen

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Guan ZhongZhen

CONTACT

86-20-87343356; tongyulin@hotmail.com

Cheng-cheng Guo

CONTACT

86-20-87343565; guochch@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice chairman of department of medical oncology

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: February 11, 2013
• Study Start: January 1, 2008
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CN (1)