Early intensification by (un)related allogeneic or autologous stem cell transplantation in adult acute lymphoblastic leukemia. A phase II study.
Completed
- Conditions
- Acute Lymphoblastic Leukemia (ALL).
- Registration Number
- NL-OMON20150
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Age between 16 and 59 (inclusive) years;
2. Previously untreated with chemotherapy;
Exclusion Criteria
1. B-ALL (= mature B-ALL);
2. Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response after each course of chemotherapy and date of CR.
- Secondary Outcome Measures
Name Time Method 1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first);<br /><br>2. Event-free survival (i.e., time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day;<br /><br>3. Overall survival will be measured from time of registration until death or last contact;<br /><br>4. Toxicities and treatment related mortality.