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Richter SyndromePhase 2NCT03931642

BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

A Phase 2 study testing RCHOP and Blinatumomab in people with Richter Syndrome, run by French Innovative Leukemia Organisation at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Richter Syndrome
What is being tested?
RCHOP and Blinatumomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
28 sitesFrance
Study dates
5 Jul 2019to 21 Oct 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma according to the revised iwCLL criteria19 with biopsy proven transformation to diffuse large B-cell lymphoma, consistent with RS according to the 2016 WHO classification
  • Both patients with previously treated or treatment-naïve CLL are eligible
  • Age greater than or equal to 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <3
  • Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of either CLL or RS cells confirmed on biopsy: absolute neutrophil count ≥1.0 G/L, platelet count ≥50 G/L independent of transfusion within 7 days of screening
  • Subject must have adequate coagulation, renal, and hepatic function at screening
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  • Adequate left ventricular ejection function (> 50 %)
  • Patients who have undergone prior allogeneic hematopoietic stem-cell transplantation (HSCT) are eligible as long as they do not have significant active graft versus host disease and that their transplant day 0 is > 6 months from their first dose of protocol therapy
  • Female patients of child bearing potential must have negative pregnancy test and use an effective method of birth control during treatment period and 48h thereafter; Males must use an effective method of birth control during treatment period and 48h thereafter.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients with the Hodgkin variant of RS
  • Patients with previously treated RS
  • History or presence of clinically relevant disorder affecting the central nervous system (CNS)
  • Known active DLBCL in the CNS (confirmed by cerebrospinal fluid analysis)
  • Steroids treatment (≥ 20 mg for one week) before inclusion
  • HSCT within 6 months before inclusion
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  • Active graft-versus-host disease
  • History of other malignancies, except: i) malignancy treated with curative intent and with no recurrence over the last 5 years ii) adequately treated non-melanoma skin cancer without evidence of disease iii) adequately treated carcinoma in situ without evidence of disease
  • History of human immunodeficiency virus
  • Hepatitis B or C seropositivity (unless clearly due to vaccination)
  • Pregnant or breastfeeding women
  • Unwilling or unable to participate in all required study evaluations and procedures.
  • Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information (in accordance with national and local subject privacy regulations)
  • Abnormal screening laboratory values as defined as following: a) serum glutamate oxaloacetate transaminase and/or serum glutamate pyruvate transaminase and/or alkaline phosphatase > or =5 x upper limit of normal (ULN); b) Total bilirubin > or = 1.5 x ULN, unless due to Gilbert's disease; c) Creatinine > or = 2.0 x ULN or creatinine clearance <50 mL/min (calculated).
  • Fertile male and female patients who cannot or do not wish to use an effective method of contraception during treatment and for 48h after the final treatment used for the purposes of the study
  • Treatment with other investigational agent or participating to another trial within 30 days prior to entering the study
  • No affiliated to social security

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • Chu Amiens

    Amiens, 80054

  • CHU ANGERS - Maladies du sang

    Angers, 49933

  • Ch Cote Basque

    Bayonne, 64109

  • Hopital Jean Minjoz

    Besançon, 25000

  • CH de Béziers - Hématologie

    Béziers, 34500

  • Hôpital Avicenne - Centre de Recherche Clinique

    Bobigny, 93009

  • CHU Caen - IHBN - Hématologie Clinique

    Caen, 14033

  • CHU Estaing - Hématologie Clinique Adulte

    Clermont-Ferrand, 63000

  • CHU Grenoble - Hématologie

    Grenoble, 388043

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Hôpital Saint Vicent de Paul

    Lille, 59000

  • Centre Léon Bérard - Hématologie

    Lyon, 69373

  • Institut Paoli-Calmettes - Hématologie Clinique

    Marseille, 13273

  • HOPITAL SAINT ELOI - Hematologie

    Montpellier, 34295

  • Hopital E.Muller

    Mulhouse, 68100

  • CHU DE NANTES - Hematologie clinique

    Nantes, 44093

  • Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

    Paris, 75651

  • CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

    Perpignan, 66000

  • Bordeaux Pessac

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

    Poitiers, 86021

  • Hôpital Robert Debré - Hématologie Clinique

    Reims, 51092

  • CHU Pontchaillou - Hématologie Clinique BMT-HC

    Rennes, 35033

  • Centre Henri Becquerel - Service Hématologie Clinique

    Rouen, 76038

  • Hôpital Hautepierre - Hématologie

    Strasbourg, 67098

  • IUCT ONCOPOLE - Hématologie

    Toulouse, 31059

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044

  • Hôpitaux de Brabois - Hématologie Adulte

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells.

The investigators propose to evaluate the efficacy, safety and tolerability of blinatumomab administered after R-CHOP debulking therapy in patients with Richter Syndrome (RS) of diffuse large B-cell lymphoma (DLBCL) histology.

The investigators hypothesize that 8-week blinatumomab induction therapy leads to Complete Response (CR) rate improvement (revised Cheson criteria) from a baseline of 7percent as observed in the prospective study evaluating R-CHOP.

Being tested
RCHOP, Blinatumomab

What participants receive

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

  • RCHOPDrug

    D1 : Rituximab 375 mg/m² IV + Cyclophosphamide 750 mg/m² IV + Doxorubicin 50 mg/m² IV + Vincristine 1.4 mg/m² IV.

    From D1 to D5 : Prednisone 60 mg/m² PO.

  • BlinatumomabDrug

    Blinatumomab by continuous vein infusion

Study groups in NCT03931642
Study groupRoleWhat they receive
R-CHOP- blinatumomabExperimentalPatients will first undergo a prior debulking therapy including 2 cycles of R-CHOP. At Day1 (D1) : Rituximab 375 mg/m² Intravenous (IV) + Cyclophosphamide 750 mg/m² IV + Doxorubicin 50 mg/m² IV + Vincristine 1.4 mg/m² IV. From D1 to D5 : Prednisone 60 mg/m² Per Os (PO). Patients with CR and no measurable lesion left will not be treated further in the setting of the present trial. All the remaining patients will be continuing and treating on study with a single cycle of blinatumomab induction therapy : Blinatumomab at 9 μg/d IV by continuous vein infusion from day 1-7, 28 μg/d from day 8-14 and 112 μg/d from day 15-56. Patients who achieve an objective response after induction are eligible to receive one further optional cycle of blinatumomab consolidation : blinatumomab 9 μg/d IV by continuous vein infusion from day 1-7, 28 μg/d from day 8-14 and 112 μg/day IV from day 15-28.
Receives: Drug: RCHOP; Drug: Blinatumomab

What is being measured

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

  1. Complete remission (CR) rate according to the revised Lugano criteria

    the objective response rate to one 8-week cycle of blinatumomab following a debulking therapy with 2 R-CHOP cycles

    Measured: at week 16 from baseline

Secondary outcomes (3)

  1. Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

    safety and toxicity of blinatumomab after 2 cycles of R-CHOP

    Measured: From the first treatment administration and during treatment period (R-CHOP and blinatomomab)

  2. overall response

    Overall response rate (revised Lugano criteria) after the first and second cycle of blinatumomab,

    Measured: At week 16 from baseline, after blinatumomab induction and at week 24 after blinatumomab consolidation.

  3. CR rate

    CR rate (revised Lugano criteria) after the second cycle of blinatumomab

    Measured: After blinatumomab consolidation (total of 4 weeks) at week 24 from the beginning of study treatment.

Timeline

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

  1. First posted30 Apr 2019
  2. Study start5 Jul 2019
  3. Primary completion1 Oct 2021
  4. Study completion21 Oct 2022

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03931642
Sponsor's protocol ID
FILOCLL13-BLINART
Status last verified
May 2023
First submitted
29 Mar 2019
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RCHOP and Blinatumomab in people with Richter Syndrome, run by French Innovative Leukemia Organisation at 28 sites in France.

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 10 inclusion and 17 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission (CR) rate according to the revised Lugano criteria (time frame: at week 16 from baseline). 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 NCT03931642.

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 24 May 2023.

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