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R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL

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ClinicalTrials.gov Identifier: NCT03018626
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ru Feng, Nanfang Hospital of Southern Medical University

Brief Summary:
This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Drug: Rituximab Drug: Etoposide Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide Drug: Prednisone Drug: Vindesine Drug: Bleomycin Phase 3

Detailed Description:

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of diffuse large-B cell lymphoma(DLBCL) was non-GCB subtype DLBCL. Although the introduction of rituximab in immunochemotherapy has dramatically improved the outcome of patients with DLBCL, The survival was still poor in non-GCB DLBCL patients treated with R-CHOP.

The LNH03-2B study has shown that R-ACVBP regimen gave a longer PFS (93% vs. 74% at 3 years, p=0.0074) and a longer OS (97% vs. 83% at 3 years, p=0.0067) than R-CHOP in young patients with non-GCB DLBCL. It also showed that R-ACVBP regimen gave a longer PFS (87% vs. 73% at 3 years, p=0.0074) and a longer OS (92% vs. 84% at 3 years, p=0.0067) than R-CHOP in young low-intermediate risk DLBCL patients. The LNH2003-3 study has shown that in high-risk (2/3 IPI factors) DLBCL patients treated with R-ACVBP followed by auto-ASCT results in a 74% PFS and 76% OS. Hematological toxic effects of the intensive regimen were raised but manageable.

The CALGB study showed that in DLBCL patients at least 18 years of age and at least stage II, DA-EPOCH-R regimen is effective in both GCB and non-GCB subtypes, with a 5-years TTP 67%, EFS 58% and OS 68% in non-GCB subtype DLBCL. It is encouraging that PETHEMA Group study showed that in the long-term follow-up of untreated DLBCL patients with poor prognosis, DA-EPOCH-R achieved a 70.8% EFS and 76.4% OS at 10 years in non-GCB subtype DLBCL.

However the efficacy of R-ACVBP compared to DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma remains unknown. All the above-mentioned results led us to propose a randomized trial comparing R-ACVBP to DA-EPOCH-R in previously untreated patients with non-GCB DLBCL.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: DA-EPOCH-R
DA-EPOCH-R regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, etoposide(50 mg/m2), doxorubicin(10 mg/m2) and vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours), cyclophosphamide(750 mg/m2)/dayg IV on days 5, prednisone (60 mg/m2) given orally bid on days 1 through to 5.All patients received granulocyte colony-stimulating factor (G-CSF) beginning on day 6 and continued until the ANC was more than 5 × 109/L above the nadir level. The adjustment paradigm was based on the ANC nadir in the previous cycle as previously described(Wilson, Grossbard et al. 2002)
Drug: Rituximab
rituximab (375 mg/m2) given intravenously (IV) on day 0

Drug: Etoposide
Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)

Drug: Doxorubicin
Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)

Drug: Vincristine
Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)

Drug: Cyclophosphamide
Cyclophosphamide(750 mg/m2)/dayg IV on days 5

Drug: Prednisone
prednisone (100 mg) given orally bid on days 1 through to 5.

Experimental: Modified R-ACVBP
R-ACVBP regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, doxorubicin (75 mg/m2) and cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1, vindesine (2 mg/m2) given on days 1 and 5, bleomycin (10 mg) given IV on days 1 and 5, prednisone (60 mg/m2) given orally on days 1 through to 5.
Drug: Rituximab
rituximab (375 mg/m2) given intravenously (IV) on day 0

Drug: Prednisone
prednisone (100 mg) given orally bid on days 1 through to 5.

Drug: Doxorubicin
Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,

Drug: Cyclophosphamide
Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,

Drug: Vindesine
Vindesine (2 mg/m2) given on days 1 and 5

Drug: Bleomycin
Bleomycin (10 mg) given IV on days 1 and 5




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Complete remission rate [ Time Frame: about 13 weeks after initial chemotherapy ]
    4 cycles after chemotherapy



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification),
  • aaIPI>1,
  • Age >18 and < 61 years,
  • Negative HIV serologies 4 weeks
  • Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

  • Any other histological type of lymphoma. Any history of treated or non-treated indolent lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contraindication to any drug contained in the chemotherapy regimens.
  • Any serious active disease (according to the investigator's decision).
  • Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018626


Contacts
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Contact: Ru Feng, M.D. ruth1626@hotmail.com
Contact: Xiaolei Wei, PH.D. smuxiaoleiwei@163.com

Locations
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China, Guangdong
Ru Feng Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ru Feng, M.D.    +86 13725119762    ruth1626@hotmail.com   
Contact: Xiaolei Wei, M.D.    +86 13826407312    smuxiaoleiwei@163.com   
Principal Investigator: Ru Feng, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Ru Feng, M.D. Department of Hematology, Nanfang Hospital, Southern Medical University

Publications:

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Responsible Party: Ru Feng, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03018626     History of Changes
Other Study ID Numbers: NFL2016-B1
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ru Feng, Nanfang Hospital of Southern Medical University:
Non-germinal b-cell-like
R-ACVBP
DA-EPOCH-R
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Vincristine
Bleomycin
Vindesine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological