"A Phase II Study With a Sequential Clofarabine-cyclophosphamide Combination Schedule as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) in Adult Patients" GIMEMA Protocol LAL1610, EudraCT Number 2010-019742-12
The proposed treatment schedule consists of a combination of Clofarabine plus
Cyclophosphamide administered over 5 consecutive days (Treatment scheme). This is an open,
nonrandomized prospective phase II trial aimed to evaluating (1) activity of this
combination in terms of CR rate.
- STEP 1. All eligible patients will be screened for the availability of an HLA-matched
or partially mismatched compatible HSCT donor, of both family related - or unrelated
type (early activation required), including cord blood and haploidentical siblings.
Moreover, pre-treatment investigation will include collection and storage of patient
ALL cells for specific biological studies relating to sensitivity and response to study
- STEP 2. Cycle 1 will be applied to all eligible patients once all enrollment criteria
- STEP 3. After cycle 1, response will be evaluated.
- STEP 4. After remission induction cycle 1, only responsive patients (CR or PR, see
below for definitions) could be given cycle 2, according to the opinion of the
responsible physician and with a minimum intercycle interval of 4 weeks from day 1 of
cycle 1. All NR patients will be declared off study and will not be given a second
course with study combination. The suggested treatment following cycle 2 (or cycle 1 if
cycle 2 is omitted) is HSCT.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end-point is the rate of patients in CR after induction therapy.
Disappearance of any clinical and laboratoristic sign of ALL. The patient must be transfusion-free with neutrophils >1.0 x109/L and platelets >100 x109/L. BM examination must show absence or reduction of blast cell content (< 5%, none of which obviously leukemic), with cellularity in the normal or slightly hypocellular range and with evidence of trilineage hemopoiesis. BM is examined on day 28 from start of chemotherapy cycle 1, or later as clinically indicated in ill/cytopenic patients, and after cycle 2 in patients with PR proceeding to this treatment.
At day +28 from start of chemotherapy cycle 1 and after cycle 2 in pts with PR
Renato BASSAN, Pr.
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Italy: Ethics Committee