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A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B


Phase 3
16 Years
80 Years
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma, Follicular Lymphoma Grade 3B

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Trial Information

A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B


Inclusion Criteria:



1. Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma
grade 3B

2. Age>=16 y.o.,<=80 y.o.

3. ECOG < 3

4. No past history of malignancy

5. Radiologically measurable disease, CT imaging in screening showing 2 or more clearly
demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion
with a largest diameter > 2.0 cm.

6. Life expectancy>6 months

7. Informed consented

Exclusion Criteria:

1. Chemotherapy before

2. Bone marrow transplantation before

3. History of malignancy

4. Active infectious disease requiring general antibiotics, anti-fungal or anti-virus
therapy

5. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious
disease

6. Primary cutaneous, CNS, mediastinal DLBCL

7. LVEF≤50%

8. Other uncontrollable medical condition that may that may interfere the participation
of the study

9. Lab at enrollment(unless caused by lymphoma)

- Neutrophile<1.5*10^9/L

- Platelet<80*10^9/L

- Hemoglobulin<100g/L

- ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN

- Creatinine>1.5*ULN

10. Not able to comply to the protocol for mental or other unknown reasons

11. Pregnant or lactation

12. Active liver or biliary disease

13. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If
HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA
positive patients cannot be enrolled.

14. HIV infection

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:

progression free survival

Outcome Time Frame:

2 year

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

NHL-001

NCT ID:

NCT01852435

Start Date:

May 2013

Completion Date:

April 2017

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma Grade 3B
  • diffuse large B-cell lymphoma
  • follicular lymphoma grade 3B
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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