Acute Lymphoblastic Leukemia (ALL)
Conditions
Interventions
In the experimental arm B intravenously administered clofarabine will be added to standard prephase chemotherapy and used in an extra consolidation cycle. Arm A is the standard arm. The study starts a
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 70 years inclusive; 2. Primary previously untreated B or T-lineage ALL (excluding -ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL); 3. Adequate renal and hepatic function tests as indicated by the following laboratory values: A. Serum creatinine ¡Ü1.0 mg/dl (¡Ü 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; B. Serum bilirubin ¡Ü 1.5 ¡Á upper limit of normal (ULN); C. Aspartate transaminase (AST)/alanine transaminase (ALT) ¡Ü 2.5 ¡Á ULN; D. Alkaline phosphatase ¡Ü 2.5 ¡Á ULN. 4. WHO performance status 0 ¨C 2; 5. Negative pregnancy test at inclusion, if applicable; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Mature surface Ig positive B-cell leukemia/lymphoma; 2. Acute undifferentiated leukemia; 3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); 4. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D); 5. Severe neurological or psychiatric disease; 6. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma; 7. Active, uncontrolled infection; 8. Patient known to be HIV-positive; 9. Patient is a lactating woman; 10. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 11. Unwilling or not capable to use effective means of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phase II part: To determine the feasibility of adding i.v. clofarabine to standard prephase therapy (followed by induction chemotherapy); 2. Phase III part: To improve EFS in adult ALL patients by the addition of i.v. clofarabine to prephase and consolidation therapy . | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase III part: 1. To improve the molecular response rate of adult ALL following RI by the addition of i.v. clofarabine to standard prephase and consolidation therapy; 2. To improve DFS, and OS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy; 3. To document safety and toxicity of adding clofarabine to standard prephase and consolidation therapy in adult ALL; 4. To assess and compare clinical outcome of patients with and without an HLA-identical sibling in a donor vs no-donor analysis. | — |
Contacts
Public ContactJ.J. Cornelissen
Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201
Outcome results
None listed