Acute Lymphoblastic Leukemia Clinical Trial
Official title:
"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"
This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide combination to treat refractory and first bone marrow relapse adult ALL, for the achievement of a complete remission (CR) and the concurrent evaluation of biological response in ALL cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).
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
chemotherapeutic combination.
- STEP 2. Cycle 1 will be applied to all eligible patients once all enrollment criteria
are confirmed.
- 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.
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