DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

NCT03837873 | Unknown Phase 2 DMC

• 1 other identifier: IIT2018010-EC-2
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 6

Brief Summary

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Conditions

Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; Transformed Lymphoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  From the date of the start of treatment until the date of first documented progression, relapse or death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcomes (4)

• ORR

  up to 3 months after the end of the therapy

• EFS

  From the date of the start of treatment until the date of the first adverse event (i.e. disease progression, relapse, diagnosis of a secondary malignancy, institution of a new anticancer treatment, any cause of death), assessed up to 2 years.

• OS

  From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.

• CRR

  up to 3 months after the end of the therapy

Study Arms (1)

DLCL002 protocol

EXPERIMENTAL

Patients will receive R-DA-EDOCH(rituximab, etoposide, dexamethasone, vincristine, cyclophosphamide, doxorubicin) as induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP(rituximab, lenalidomide(only for patients with non-GCB DLBCL), dexamethasone, cisplatin, cytarabine). Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments.

Drug: Rituximab; Drug: Etoposide; Drug: Vincristine; Drug: Doxorubicin; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Lenalidomide; Drug: Cisplatin; Drug: Cytarabine

Interventions

Rituximab DRUG

rituximab 750mg/m2 i.v. on day 0

DLCL002 protocol

Etoposide DRUG

50mg/m2, continuous i.v. on day 1-4

DLCL002 protocol

Vincristine DRUG

0.4mg/m2, continuous i.v. on day 1-4

DLCL002 protocol

Doxorubicin DRUG

10mg/m2, continuous i.v. on day 1-4

DLCL002 protocol

Dexamethasone DRUG

30mg/day, i.v. on day 1-5 for R-DA-EDOCH regimen; 40mg/day, i.v. on day 1-4 for R(2)-DHAP regimen

DLCL002 protocol

Cyclophosphamide DRUG

750mg/m2, i.v. on day5

DLCL002 protocol

Lenalidomide DRUG

25mg/day, p.o. on day 0-9

DLCL002 protocol

Cisplatin DRUG

100mg/m2 continuous i.v. on day 1

DLCL002 protocol

Cytarabine DRUG

2g/m2 q12h, i.v. on day 2

DLCL002 protocol

Eligibility Criteria

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

You may qualify if:

• Histological confirmed aggressive B-cell lymphoma with one of the following subtypes:
• diffuse large B-cell lymphoma, NOS with at least one poor prognostic factor as follows:
• aaIPI 2\~3(≤60 years) or IPI 3\~5(\>60 years);
• double protein expression lymphoma(IHC MYC≥40% and BCL2≥50%） with Ann Arbor stage of III\~IV or aaIPI 2\~3 or IPI 3\~5;
• CD5+ DLBCL.
• high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;
• high-grade B-cell lymphoma, NOS
• transformed lymphoma(no prior treatment)
• Age 18 to 65 years
• ECOG-PS: 0\~2
• Life-expectancy \> 3 months

You may not qualify if:

• Patients with central nerves system involvement
• HIV positivity

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (6)

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

the First Affiliated Hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

the Second Hospital of Dalian Medical University

Dalian, Liaoning, China

NOT YET RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, China

NOT YET RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Etoposide; Vincristine; Doxorubicin; Dexamethasone; Cyclophosphamide; Lenalidomide; Cisplatin; Cytarabine

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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dehui Zou, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu, Dr.

CONTACT

+86-020-23909282; liuwei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: February 12, 2019
• Study Start: January 21, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

CN (6)