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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B ALL, CD22+ Expression, Refractory B-ALL

Thank you

Trial Information

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.


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 ┬Ámom/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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response rate (CR and CRp)

Safety Issue:

No

Principal Investigator

Patrice CHEVALLIER, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital

Authority:

France : AFSSAPS - French Health Prducts Safety Agency

Study ID:

BRD 10/05-O

NCT ID:

NCT01219816

Start Date:

October 2010

Completion Date:

Related Keywords:

  • B ALL
  • CD22+ Expression
  • Refractory B-ALL
  • efficacy of Chemo-immunotherapy
  • Burkitt Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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