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Diffuse Large B Cell LymphomaPhase 2CyBeR-LymphNCT02758925

CyBeR Association in Relapsed/Refractory DLBCL

A Phase 2 study testing Rituximab, Bendamustine and Cytarabine in people with Diffuse Large B Cell Lymphoma, run by University Hospital, Caen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Rituximab, Bendamustine and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
No sites listed yet
Study dates
Jun 2016to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients from 18 to 75 years
  • Patient sharpened the social security system
  • 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
  • Not previously treated with bendamustine
  • WHO performance status 0, 1 or 2
  • Adequate hematological function as defined by: leucocyte count ≥ 3.0 109/L, platelet count ≥ 75 109/L
  • Females of childbearing potential must agree to have a medically acceptable method of contraception from study treatment initiation until the end of treatment.
  • Signed informed consent.

Who cannot join

  • Person under guardianship or curatorship , or unable to understand the purpose of the study
  • Central nervous system or meningeal involvement
  • WHO performance status more than 2
  • Contraindication to any drug contained in the chemotherapy regimen
  • HIV disease, active hepatitis B or C
  • Any serious active disease or co-morbid medical condition
Show all 19Show fewer
  • Any of the following laboratory abnormalities.
  • Leucocyte count < 3.0 x 109/L
  • Platelet count < 75 x 109/L
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • 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).
  • renal impairment with an estimated (modified dietin renal disease; MDRD) creatinine clearance < 40 ml/min,
  • chronic liver disease or day-1 (AST/ALT )≥2.5 upper limit of normal (ULN), total bilirubin≥1.5 ULN,

Trial locations and contacts

No sites are listed yet.

Emilie Reboursiere, MD contact

+33231272140

reboursiere-e@chu-caen.fr

About this study

Official title: Phase 2 Study of Cytarabine in Association With Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma

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.

Read more

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.

Read the 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.

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called mabthera

    375mg/m2 IV day 1

  • BendamustineDrug

    Also called levact

    90mg/m2 IV day 1-2

  • CytarabineDrug

    Also called aracytine

    1000mg/m2 or 750mg/m2 at day 2 if patients aged more than 70 years or toxicity grade 3/4

Study groups in NCT02758925
Study groupRoleWhat they receive
DLBCL patientsExperimentalthey 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
Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment response

    established with 1999 Cheson criteria on CT-scan

    Measured: up to 20 weeks (at the end of the treatment)

Secondary outcomes (2)

  1. overall survival

    Measured: 2 years

  2. progression free survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionNov 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758925
Sponsor's protocol ID
2015-005837-37
Other IDs
2015
Acronym
CyBeR-Lymph
Status last verified
May 2016
First submitted
14 Apr 2016
Last updated
4 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ohmachi K, Niitsu N, Uchida T, Kim SJ, Ando K, Takahashi N, Takahashi N, Uike N, Eom HS, Chae YS, Terauchi T, Tateishi U, Tatsumi M, Kim WS, Tobinai K, Suh C, Ogura M. Multicenter phase II study of bendamustine plus rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2013 Jun 10;31(17):2103-9. doi: 10.1200/JCO.2012.46.5203. Epub 2013 May 6.

    PubMed 23650408

  • Castegnaro S, Visco C, Chieregato K, Bernardi M, Albiero E, Zanon C, Madeo D, Rodeghiero F. Cytosine arabinoside potentiates the apoptotic effect of bendamustine on several B- and T-cell leukemia/lymphoma cells and cell lines. Leuk Lymphoma. 2012 Nov;53(11):2262-8. doi: 10.3109/10428194.2012.688200. Epub 2012 May 21.

    PubMed 22530665

  • Vacirca JL, Acs PI, Tabbara IA, Rosen PJ, Lee P, Lynam E. Bendamustine combined with rituximab for patients with relapsed or refractory diffuse large B cell lymphoma. Ann Hematol. 2014 Mar;93(3):403-9. doi: 10.1007/s00277-013-1879-x. Epub 2013 Aug 17.

    PubMed 23955074

  • Visco C, Finotto S, Pomponi F, Sartori R, Laveder F, Trentin L, Paolini R, Di Bona E, Ruggeri M, Rodeghiero F. The combination of rituximab, bendamustine, and cytarabine for heavily pretreated relapsed/refractory cytogenetically high-risk patients with chronic lymphocytic leukemia. Am J Hematol. 2013 Apr;88(4):289-93. doi: 10.1002/ajh.23391. Epub 2013 Feb 28.

    PubMed 23450436

  • Visco C, Finotto S, Zambello R, Paolini R, Menin A, Zanotti R, Zaja F, Semenzato G, Pizzolo G, D'Amore ES, Rodeghiero F. Combination of rituximab, bendamustine, and cytarabine for patients with mantle-cell non-Hodgkin lymphoma ineligible for intensive regimens or autologous transplantation. J Clin Oncol. 2013 Apr 10;31(11):1442-9. doi: 10.1200/JCO.2012.45.9842. Epub 2013 Feb 11.

    PubMed 23401442

  • Mounier N, El Gnaoui T, Tilly H, Canioni D, Sebban C, Casasnovas RO, Delarue R, Sonet A, Beaussart P, Petrella T, Castaigne S, Bologna S, Salles G, Rahmouni A, Gaulard P, Haioun C. Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial. Haematologica. 2013 Nov;98(11):1726-31. doi: 10.3324/haematol.2013.090597. Epub 2013 Jun 10.

    PubMed 23753028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Bendamustine and Cytarabine in people with Diffuse Large B Cell Lymphoma, run by University Hospital, Caen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emilie Reboursiere, MD (+33231272140, reboursiere-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment response (time frame: up to 20 weeks (at the end of the treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758925, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.

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