Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.

Completed

Conditions: Acute lymphoblastic leukemia
10024324

Registration Number: NL-OMON41476

Lead Sponsor: HOVO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 285

Inclusion Criteria

- Patients aged 18 to 70 years inclusive
- Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL (pretreatment with prednisone for 7 days is allowed)
- WHO performance status 0 - 2
- Adequate renal and hepatic function tests as indicated by the following laboratory
values:
- Serum creatinine <=1.0 mg/dl (<= 88.7 micromol/L); if serum creatinine >1.0 mg/dl
(>88.7 micromol/L), then the glomerular filtration rate (GFR) must be
>60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease
equation where the predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine
in mg/dl)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if
patient is black)
NOTE: if serum creatinine is measured in micromol/L, recalculate it in mg/dl
according to the equation: 1 mg/dl = 88.7 micromol/L) and used above
mentioned formula.
- Serum bilirubin <= 1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST)/alanine transaminase (ALT) <= 2.5 × ULN
- Alkaline phosphatase <= 2.5 × ULN
- Negative pregnancy test at inclusion, if applicable
- Written informed consent

Exclusion Criteria

- Mature surface Ig positive B-cell leukemia/lymphoma
- Acute undifferentiated leukemia
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- Severe pulmonary dysfunction (CTCAE grade III-IV)
- Severe neurological or psychiatric disease
- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- Active, uncontrolled infection
-Patient known to be HIV-positive
-Patient is a lactating woman
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 yrs for at least one year)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Feasiblilty of clofarabine when added to standard phrephase chemotherapy.<br /><br><br /><br>2. Event-free survival (EFS) (i.e., time from registration to induction<br /><br>failure, death or relapse whichever occurs first).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response<br /><br>- Overall survival (OS) mesured form the time of registration<br /><br>- Disease-free interval (duration of the first CR) measured form the time of<br /><br>achievement of CR to day of relapse or death from any cause (whichever occurs<br /><br>first).<br /><br>- Outcome of treatment in relation to minimal residual disease measurements.<br /><br>- Evaluation of toxicities and treatment related mortality.</p><br>

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