Reduced Chemotherapy in Low Risk DLBCL

Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02752815

Enrollment

290

Registered

2016-04-27

Start date

2016-06-14

Completion date

2024-12-31

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Brief summary

This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.

Interventions

DRUGRituximab

DRUGCyclophosphamide

DRUGEpirubicin

DRUGVincristine

DRUGPrednisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21 * Age\>=14 y.o.,\<=75 y.o. * IPI=0-1 * non-bulky (largest diameter \<7.5cm) * ECOG =0-1 * Life expectancy\>6 months * Informed consented

Exclusion criteria

* Chemotherapy before * Stem cell transplantation before * History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * Primary cutaneous, CNS DLBCL * LVEF≤50% * Other uncontrollable medical condition that may that may interfere the participation of the study * 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 * Not able to comply to the protocol for mental or other unknown reasons * Pregnant or lactation * 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. * HIV infection

Design outcomes

Primary

Measure	Time frame
Progression free survival	2-year

Secondary

Measure	Time frame
Overall survival	2-year
Complete Response rate	21 days after 8 cycles of treatment（each cycle is 21 days）
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026