Reduced Chemotherapy in Low Risk DLBCL

NCT ID: NCT02752815

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-14

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B-cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

6R-CHOP+2R

6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days

2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

4R-CHOP+4R

4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days

2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rituximab

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhao Weili

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Weili Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Shi Q, He Y, Yi HM, Mu RJ, Jiang XF, Fu D, Dong L, Qin W, Xu PP, Cheng S, Song Q, Chen SJ, Wang L, Zhao WL. Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial. Cancer Commun (Lond). 2023 Aug;43(8):896-908. doi: 10.1002/cac2.12462. Epub 2023 Jul 4.

Reference Type DERIVED
PMID: 37403255 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NHL-006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chidamide Plus R-CHOP in Elderly DLBCL
NCT02753647 UNKNOWN PHASE2
Dynamic CtDNA-guided Targeted Therapy in DLBCL
NCT06748521 NOT_YET_RECRUITING PHASE2