Clincosm LogoSign in Get a demo

CHEPRALL: Multi-centric Study

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01219816
Collaborator
(none)
57
Enrollment
11
Locations
2
Arms
72
Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients under 60 years

Hyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)

Drug: Epratuzumab
Combination of chemotherapy + Epratuzumab
Experimental: Patients older than 60 years or < =60 years

Vincristine + Aracytine + Dexamethasone

Drug: Epratuzumab
Vincristine + Dexamethasone + Epratuzumab

Outcome Measures

Primary Outcome Measures

  1. complete response rate (CR and CRp) []

Secondary Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

  • Performance status 0-2

  • Creatinine clearance >= 50 ml/min (Cockroft formula)

  • Serum bilirubine <= 30 µmom/l

  • Written informed consent

Exclusion Criteria:

  • 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Angers University Hospital Angers France 49933
2 University Hospital Caen France 14000
3 HEnri Mondor Hospital Creteil France 94010
4 Edouard Herriot Hospital Lyon France 69437
5 Institut Paoli Calmette Marseille France 13373
6 Nantes University Hospital Nantes France 44000
7 Saint Louis Hospital Paris France 75010
8 St Antoine Paris France 75015
9 Haut-Leveque Hospital Pessac France 33604
10 CHU de Poitiers Poitiers France 86021
11 Purpan Hospital Toulouse France 37509

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Patrice CHEVALLIER, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01219816
Other Study ID Numbers:
  • BRD/10/05-O
First Posted:
Oct 13, 2010
Last Update Posted:
Feb 27, 2018
Last Verified:
Nov 1, 2016
Keywords provided by Nantes University Hospital
efficacy of Chemo-immunotherapy
Additional relevant MeSH terms:
Epratuzumab

Study Results

No Results Posted as of Feb 27, 2018