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Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients


Inclusion Criteria:



- Age 18-70 years

- B-ALL (OMS) with >=20% of blasts in bone marrow

- CD22+ expression >=70% of the blast population

- All previously treated ALL patients who have experienced relapse or treatment failure

- At least 15 days since previous treatment

- Performance status 0 - 2

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

- Serum bilirubin <= 30 mmol/l

- Written informed consent

Exclusion Criteria:

- T-ALL

- Meningeal involvement

- CD22 expression on tumor cells or < 70%

- HIV positive

- Active Hepatitis B or C

- Active infection within 7 days of starting treatment

- Left ventricular ejection fraction < 50%.

- Contra-indication to 90Y-DOTA-hLL2

- 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: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of MTD by evaluation of hematological and non hematoligical toxicity

Outcome Description:

The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) after J30 and J37 in order to determine the maximal tolerated dose (MTD) in a dose escalating study design

Safety Issue:

Yes

Principal Investigator

Chevallier Patrice, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 08/12-H

NCT ID:

NCT01354457

Start Date:

November 2010

Completion Date:

November 2012

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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