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

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Brief Title

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

Official Title

A Prospective , Multicenter, RandomizedPhase III Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients

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
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

5-year overall survival

Secondary Outcome

 DFS

Condition

T-cell Lymphoma Adults

Intervention

chemotherapy (CHOP)

Study Arms / Comparison Groups

 CHOP
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

380

Start Date

January 2008

Completion Date

December 2017

Primary Completion Date

April 2017

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Guan ZhongZhen, 86-20-87343356, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01788137

Organization ID

CSWOG0002


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Collaborators

 Chinese Academy of Medical Sciences

Study Sponsor

Guan ZhongZhen, Study Chair, Sun Yat-sen University


Verification Date

December 2015