Biomarker Guided Treatment in DLBCL

NCT04025593 | Unknown Phase 2

• 1 other identifier: Guidance-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• complete response rate

  21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary Outcomes (4)

• progression free survival

  2 year

• overall survival

  2 year

• overall response rate

  21 days after 6 cycles of treatment (each cycle is 21 days)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Up to 30 days after completion of study treatment

Study Arms (2)

RCHOP

ACTIVE COMPARATOR

Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

RCHOPX

EXPERIMENTAL

Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Ibrutinib; Drug: Lenalidomide; Drug: chidamide; Drug: decitabine

Interventions

Cyclophosphamide DRUG

750mg/m2 day 1

RCHOP; RCHOPX

Rituximab DRUG

375mg/m2 day 0

RCHOP; RCHOPX

Doxorubicin DRUG

50mg/m2 day 1

RCHOP; RCHOPX

Vincristine DRUG

1.4mg/m2, max 2mg day 1

RCHOP; RCHOPX

Prednisone DRUG

60mg/m2, max 100mg day 1-5

RCHOP; RCHOPX

Ibrutinib DRUG

420mg/day qd

RCHOPX

Lenalidomide DRUG

25mg day1-10

RCHOPX

chidamide DRUG

20mg day 1,4,8,11

RCHOPX

decitabine DRUG

decitabine 10mg/m2 day-5 to day-1

RCHOPX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
• ECOG 0,1,2
• Life expectancy\>6 months
• Informed consented
• IPI\>1

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 CNS lymphoma
• LVEF≤50%
• Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Prednisone; ibrutinib; Lenalidomide; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Decitabine

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Azacitidine; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

WL Z, MD PhD

CONTACT

64370045; zhao.weili@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of hematology department

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: July 17, 2019
• Primary Completion: July 1, 2021
• Study Completion: June 1, 2023
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)