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


- candidate number6446
- NTR NumberNTR2004
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2009
- Secondary IDsHo100 EudraCT 2008-005798-36
- Public TitleClofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.
- Scientific TitleClofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.
- ACRONYMHOVON 100 ALL
- hypothesisThe hypothesis to be tested in the phase II part is that arm B is feasible.
The hypothesis to be tested in the phase III part is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL)
- Inclusion criteria1. 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 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;
B. Serum bilirubin 1.5 upper limit of normal (ULN);
C. Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN;
D. Alkaline phosphatase 2.5 ULN.
4. WHO performance status 0 C 2;
5. Negative pregnancy test at inclusion, if applicable;
6. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate12-jan-2015
- Target number of participants340
- InterventionsIn 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 at a dose level of 20 mg/m2, and if possible escalating to 30 mg/m2. If 20 mg/m2 is not feasible we will study 15 mg/m2.
- Primary outcome1. 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 outcomePhase 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.
- Timepoints1. At entry;
2. Pre-phase;
3. Induction;
4. Consolidation;
5. Interphase;
6. Intensification;
7. Allo-SCT;
8. Maintenance;
9. Follow-up (every 6 months.
- Trial web sitewww.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J. Cornelissen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Cornelissen
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Genzyme Corporation, Koningin Wilhelmina Fonds (KWF), Medac, HOVON
- PublicationsN/A
- Brief summaryStudy phase: Phase II/III.

Study objective:
Phase II: To determine the feasibility of i.v. clofarabine given prior to standard induction chemotherapy as part of pre-phase.
Phase III: To improve event free survival by adding i.v. clofarabine to prephase and consolidation therapy Patient population: Patients with previously untreated ALL, age 18-70 years.

Study design:
Phase II: Comparative, randomized feasibility study (dose-finding) of clofarabine chemotherapy at three possible dose levels 15, 20, or 30 mg/m2.
Phase III: Multicenter study at the selected feasible dose level of clofarabine in a prospective randomized approach between clofarabine combined with pre-phase therapy and in an extra consolidation cycle versus the same chemotherapy without addition of clofarabine.

Duration of treatment:
Expected duration of 32 months, maintenance therapy of 24 months inclusive. All patients will be followed until 10 years after randomization.
- Main changes (audit trail)
- RECORD10-sep-2009 - 12-okt-2009


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