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

Phase 1

• Conditions: 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; MedDRA version: 17.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10043028Term: T-lymphoblastic lymphoma (Kiel Classification)System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-005798-36-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-25
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 376

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 prednisolone 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 326
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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, see appendix D)
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified