Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation.
Recruiting
- Conditions
- Recurrent aggressive B-cell lymphoma with CNS localisation, DLBCL, non-hodgkin lymphoma, NH
- Registration Number
- NL-OMON23427
- 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
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
1. Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification:
A. Follicular lymphoma grade III;
Exclusion Criteria
1. History of intolerance of exogenous protein administration;
2. Severe cardiac dysfunction (NYHA classification III-IV, or LVEF < 45%);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive.
- Secondary Outcome Measures
Name Time Method 1. Response to R-DHAP-MTX;<br /><br>2. Overall survival;<br /> <br>3. Toxicity;<br /><br>4. Percentage of patients transplanted.