Multi-centric Study

NCT01219816 | Completed Phase 2 DMC

• 1 other identifier: BRD/10/05-O
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 11

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

Keywords

efficacy of Chemo-immunotherapy

Outcome Measures

Primary Outcomes (1)

• complete response rate (CR and CRp)

Secondary Outcomes (5)

• Overall response rate (ORR)(CR, CRp and PR)

• Overall survival

• Disease free survival

• CD22 expression after Epratuzumab

• Safety and tolerance of Epratuzumab in combination with chemotherapy

Study Arms (2)

Patients under 60 years

EXPERIMENTAL

Hyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)

Drug: Epratuzumab

Patients older than 60 years or < =60 years

EXPERIMENTAL

Vincristine + Aracytine + Dexamethasone

Drug: Epratuzumab

Interventions

Epratuzumab DRUG

Combination of chemotherapy + Epratuzumab

Patients under 60 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (11)

Angers University Hospital

Angers, 49933, France

Location

University Hospital

Caen, 14000, France

Location

HEnri Mondor Hospital

Créteil, 94010, France

Location

Edouard Herriot Hospital

Lyon, 69437, France

Location

Institut Paoli Calmette

Marseille, 13373, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

Saint Louis Hospital

Paris, 75010, France

Location

St Antoine

Paris, 75015, France

Location

Haut-Leveque Hospital

Pessac, 33604, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Purpan Hospital

Toulouse, 37509, France

Location

MeSH Terms

Interventions

epratuzumab

Study Officials

• Patrice CHEVALLIER, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 27, 2018

Record last verified: 2016-11

Locations

FR (11)