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Trial record 2 of 2 for:    20393178 [PUBMED-IDS]

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

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE January 12, 2017
Last Update Posted Date July 28, 2017
Actual Study Start Date  ICMJE July 27, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Progression-free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03018626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Overall survival [ Time Frame: 3 years ]
  • Complete remission rate [ Time Frame: about 13 weeks after initial chemotherapy ]
    4 cycles after chemotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL
Official Title  ICMJE Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Large B-Cell, Diffuse
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Rituximab
    • Drug: Etoposide
    • Drug: Doxorubicin
    • Drug: Vincristine
    • Drug: Cyclophosphamide
    • Drug: Prednisone
  • 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.
    Interventions:
    • Drug: Rituximab
    • Drug: Prednisone
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
    • Drug: Vindesine
    • Drug: Bleomycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
402
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ru Feng, M.D. ruth1626@hotmail.com
Contact: Xiaolei Wei, PH.D. smuxiaoleiwei@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03018626
Other Study ID Numbers  ICMJE NFL2016-B1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ru Feng, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ru Feng, M.D. Department of Hematology, Nanfang Hospital, Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP