Multi-centric Study

B ALL Clinical Trial

— CHEPRALL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219816
• Other study ID #: BRD/10/05-O
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: February 26, 2018
• Start date: November 2010
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B ALL
• Burkitt Lymphoma
• CD22+ Expression
• Refractory B-ALL

Intervention

Drug:
• Epratuzumab
Combination of chemotherapy + Epratuzumab
• Epratuzumab
Vincristine + Dexamethasone + Epratuzumab

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	University Hospital	Caen
France	HEnri Mondor Hospital	Creteil
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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate (CR and CRp)
Secondary	Overall response rate (ORR)(CR, CRp and PR)
Secondary	Overall survival
Secondary	Disease free survival
Secondary	CD22 expression after Epratuzumab
Secondary	Safety and tolerance of Epratuzumab in combination with chemotherapy