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CyBeR Association in Relapsed/Refractory DLBCL (CyBeR-Lymph)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02758925
Recruitment Status : Unknown
Verified May 2016 by Emilie REBOURSIERE, University Hospital, Caen.
Recruitment status was:  Not yet recruiting
First Posted : May 3, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Emilie REBOURSIERE, University Hospital, Caen

Brief Summary:

Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no ASCT is possible due to progressive disease. For these patients or ineligible to transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine regimen with an overall response rate (ORR) about 50%.

Bendamustine in combination with rituximab, used as a single agent in the setting of R/R DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.

Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine with Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were previously untreated, refractory or relapsed was evaluated.

The efficacy and safety of the R-BAC association will be evaluated in this phase II trial enrolling 78 patients with relapsed or refractory DLBCL.


Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Rituximab Drug: Bendamustine Drug: Cytarabine Phase 2

Detailed Description:

Participants will received 6 cycles every 21 days with a follow-up period of 24 months.

CT-Scan after 3 cycles and at the end of the treatment will be used to assess treatment response, established with Cheson criteria in 1999.

Principal objective is to obtain an overall response rate of 60% (corresponding to an increased of 15% of the rituximab-gemcitabine-oxaliplatine regimen's overall response rate).

Secondaries objectives are to value toxicity, progression free survival and overall survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Cytarabine in Association With Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
Study Start Date : June 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: DLBCL patients
they will receive a combination of: Rituximab 375mg/m2 IV at Day 1 Bendamustine 90mg/m2 IV at Day 1 and 2 Cytarabine 1000mg/m2 IV at day 2 every 21 days for 6 cycles
Drug: Rituximab
375mg/m2 IV day 1
Other Name: mabthera

Drug: Bendamustine
90mg/m2 IV day 1-2
Other Name: levact

Drug: Cytarabine
1000mg/m2 or 750mg/m2 at day 2 if patients aged more than 70 years or toxicity grade 3/4
Other Name: aracytine




Primary Outcome Measures :
  1. treatment response [ Time Frame: up to 20 weeks (at the end of the treatment) ]
    established with 1999 Cheson criteria on CT-scan


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
  2. progression free survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients from 18 to 75 years
  2. Patient sharpened the social security system
  3. Patients with relapsed or refractory diffuse large B cell lymphoma who received at least one prior line of immunochemotherapy unfit for intensive regimen therapy and autologous stem cell transplantation (ASCT) eligible patients to stem cell transplantation with failure of the salvage therapy patients with relapse after ASCT
  4. Not previously treated with bendamustine
  5. WHO performance status 0, 1 or 2
  6. Adequate hematological function as defined by: leucocyte count ≥ 3.0 109/L, platelet count ≥ 75 109/L
  7. Females of childbearing potential must agree to have a medically acceptable method of contraception from study treatment initiation until the end of treatment.
  8. Signed informed consent.

Exclusion Criteria:

  1. Person under guardianship or curatorship , or unable to understand the purpose of the study
  2. Central nervous system or meningeal involvement
  3. WHO performance status more than 2
  4. Contraindication to any drug contained in the chemotherapy regimen
  5. HIV disease, active hepatitis B or C
  6. Any serious active disease or co-morbid medical condition
  7. Any of the following laboratory abnormalities.

    • Leucocyte count < 3.0 x 109/L
    • Platelet count < 75 x 109/L
  8. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  9. Pregnant or lactating females.
  10. Prior history of malignancies, other than lymphoma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:

    • Basal cell carcinoma of the skin.
    • Squamous cell carcinoma of the skin.
    • Carcinoma in situ of the cervix.
    • Carcinoma in situ of the breast.
    • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
  11. renal impairment with an estimated (modified dietin renal disease; MDRD) creatinine clearance < 40 ml/min,
  12. chronic liver disease or day-1 (AST/ALT )≥2.5 upper limit of normal (ULN), total bilirubin≥1.5 ULN,

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): NCT02758925


Contacts
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Contact: Emilie Reboursiere, MD +33231272140 reboursiere-e@chu-caen.fr

Sponsors and Collaborators
University Hospital, Caen
Investigators
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Study Director: Gandhi Damaj, PHD University Hospital, Caen
Publications of Results:
Other Publications:

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Responsible Party: Emilie REBOURSIERE, MD, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02758925    
Other Study ID Numbers: 2015-005837-37
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents