Reduced Chemotherapy in Low Risk DLBCL

NCT02752815 | Unknown Phase 4 DMC

• 1 other identifier: NHL-006
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  2-year

Secondary Outcomes (3)

• 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

Study Arms (2)

6R-CHOP+2R

ACTIVE COMPARATOR

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

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

4R-CHOP+4R

EXPERIMENTAL

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

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Rituximab DRUG

4R-CHOP+4R; 6R-CHOP+2R

Cyclophosphamide DRUG

4R-CHOP+4R; 6R-CHOP+2R

Epirubicin DRUG

4R-CHOP+4R; 6R-CHOP+2R

Vincristine DRUG

4R-CHOP+4R; 6R-CHOP+2R

Prednisone DRUG

4R-CHOP+4R; 6R-CHOP+2R

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200023, China

Location

Related Publications (1)

• 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.

  PMID: 37403255 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Epirubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Weili Zhao, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 27, 2016
• Study Start: June 14, 2016
• Primary Completion: October 30, 2022
• Study Completion: December 31, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

CN (1)