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B ALLPhase 2CHEPRALLNCT01219816

Multi-centric Study

A Phase 2 study testing Epratuzumab in people with B ALL and CD22+ Expression, run by Nantes University Hospital at 11 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

Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B ALL, CD22+ Expression, Refractory B-ALL
What is being tested?
Epratuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
11 sitesFrance
Study dates
Nov 2010to Nov 2016
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

  • Age >= 18 years
  • B-ALL (OMs) with >= 20 % of blasts in bone marrow
  • CD22+ expression >= 30% of the blast population
  • Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse < 6 months after first CR
  • First relapse of B-ALL
  • Second relapse or beyond
Show all 10Show fewer
  • Performance status 0-2
  • Creatinine clearance >= 50 ml/min (Cockroft formula)
  • Serum bilirubine <= 30 µmom/l
  • Written informed consent

Who cannot join

  • T-ALL
  • Meningeal involvement
  • CD22 expression on tumor cells or < 30%
  • HIV positive
  • Active Hepatitis B or C
  • Left ventricular ejection fraction < 50% in patients <60 years
Show all 11Show fewer
  • Contra-indication to Epratuzumab
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Participation at the same time in another study in which investigational drugs are used
  • Absence of written informed consent

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Angers University Hospital

    Angers, 49933

  • University Hospital

    Caen, 14000

  • HEnri Mondor Hospital

    Créteil, 94010

  • Edouard Herriot Hospital

    Lyon, 69437

  • Institut Paoli Calmette

    Marseille, 13373

  • Nantes University Hospital

    Nantes, 44000

  • Saint Louis Hospital

    Paris, 75010

  • St Antoine

    Paris, 75015

  • Haut-Leveque Hospital

    Pessac, 33604

  • CHU de Poitiers

    Poitiers, 86021

  • Purpan Hospital

    Toulouse, 37509

Other trials in France

About this study

Official title: Phase II, Multicenter, Open Label, Prospective to Evaluate Efficacy and Tolerance of a Chemoimmunotherapy With HyperCVAD or Vincristine/Dexamethasone Plus the Anti-CD22 Monovlonal Antobody Epratuzumab for the Treatment of Adult Relapsed/Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients : CHEPRALL Study, a GRAALL Study.

Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (>=60 years)or young patients <= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR.

More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable.

The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.

Being tested
Epratuzumab
Keywords
efficacy of Chemo-immunotherapy

What participants receive

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

  • EpratuzumabDrug

    Combination of chemotherapy + Epratuzumab

  • EpratuzumabDrug

    Vincristine + Dexamethasone + Epratuzumab

Study groups in NCT01219816
Study groupRoleWhat they receive
Patients under 60 yearsExperimentalHyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)
Receives: Drug: Epratuzumab
Patients older than 60 years or < =60 yearsExperimentalVincristine + Aracytine + Dexamethasone
Receives: Drug: Epratuzumab

What is being measured

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

  1. complete response rate (CR and CRp)

Secondary outcomes (5)

  1. Overall response rate (ORR)(CR, CRp and PR)

  2. Overall survival

  3. Disease free survival

  4. CD22 expression after Epratuzumab

  5. Safety and tolerance of Epratuzumab in combination with chemotherapy

Timeline

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

  1. First posted13 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2016
  4. Study completionNov 2016

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01219816
Sponsor's protocol ID
BRD/10/05-O
Acronym
CHEPRALL
Status last verified
Nov 2016
First submitted
12 Oct 2010
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Chevallier P, Huguet F, Raffoux E, Etienne A, Leguay T, Isnard F, Robillard N, Guillaume T, Delaunay J, Charbonnier A, Pigneux A, Peterlin P, Bene MC, Wegener WA, Goldenberg DM, Dombret H. Vincristine, dexamethasone and epratuzumab for older relapsed/refractory CD22+ B-acute lymphoblastic leukemia patients: a phase II study. Haematologica. 2015 Apr;100(4):e128-31. doi: 10.3324/haematol.2014.120220. Epub 2014 Dec 31. No abstract available.

    PubMed 25552705

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epratuzumab in people with B ALL and CD22+ Expression, run by Nantes University Hospital at 11 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 11 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 response rate (CR and CRp). 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 NCT01219816, which also lists 1 linked publication.

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 14 Sep 2026.

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