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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
T-cell Lymphoma Adults, Previously Untreated, High Risk

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5-year overall survival

Outcome Time Frame:

5-year

Safety Issue:

No

Principal Investigator

Guan ZhongZhen

Investigator Role:

Study Chair

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

CSWOG0002

NCT ID:

NCT01788137

Start Date:

January 2008

Completion Date:

December 2017

Related Keywords:

  • T-cell Lymphoma Adults
  • Previously Untreated
  • High Risk
  • T-cell lymphoma,DFS,OS
  • Lymphoma
  • Lymphoma, T-Cell

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