Multi-centric Study

NCT ID: NCT01219816

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

B ALL; CD22+ Expression; Refractory B-ALL

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients under 60 years

Hyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)

Group Type: EXPERIMENTAL

Epratuzumab

Intervention Type: DRUG

Combination of chemotherapy + Epratuzumab

Patients older than 60 years or < =60 years

Vincristine + Aracytine + Dexamethasone

Group Type: EXPERIMENTAL

Epratuzumab

Intervention Type: DRUG

Vincristine + Dexamethasone + Epratuzumab

Interventions

Epratuzumab

Combination of chemotherapy + Epratuzumab

Intervention Type: DRUG

Epratuzumab

Vincristine + Dexamethasone + Epratuzumab

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice CHEVALLIER, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Angers University Hospital

Angers, , France

University Hospital

Caen, , France

HEnri Mondor Hospital

Créteil, , France

Edouard Herriot Hospital

Lyon, , France

Institut Paoli Calmette

Marseille, , France

Nantes University Hospital

Nantes, , France

Saint Louis Hospital

Paris, , France

St Antoine

Paris, , France

Haut-Leveque Hospital

Pessac, , France

CHU de Poitiers

Poitiers, , France

Purpan Hospital

Toulouse, , France

Countries

France

Other Identifiers

BRD/10/05-O

Identifier Type: -

Identifier Source: org_study_id