Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Registration Number
- NL-OMON28093
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 340
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);
Exclusion Criteria
1. Mature surface Ig positive B-cell leukemia/lymphoma;
2. Acute undifferentiated leukemia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Phase II part: To determine the feasibility of adding i.v. clofarabine to standard prephase therapy (followed by induction chemotherapy);<br /><br>2. Phase III part: To improve EFS in adult ALL patients by the addition of i.v. clofarabine to prephase and consolidation therapy .
- Secondary Outcome Measures
Name Time Method Phase III part:<br /><br>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;<br /><br>2. To improve DFS, and OS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy;<br /><br>3. To document safety and toxicity of adding clofarabine to standard prephase and consolidation therapy in adult ALL;<br /> <br>4. To assess and compare clinical outcome of patients with and without an HLA-identical sibling in a donor vs no-donor analysis.