Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High- risk Relapsed or Refractory CLLA prospective multi-centre phase II study
- Conditions
- Refractory or relapsed Chronic Lymphocytic Leukemia
- Registration Number
- NL-OMON27777
- 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
- 50
Inclusion Criteria
1. B-CLL confirmed according to WHO Classification;
2. Fludarabine refractory, defined as no response or relapse within 12 months after the last administration of fludarabine monotherapy or fludarabine containing regimen, and needing treatment, or Refractory or relapsed and needing treatment and having deletion of 17p13 or Refractory or relapsed within 24 months after the last administration of fludarabine combined with a monoclonal antibody and needing treatment;
Exclusion Criteria
1. Intolerance to exogenous protein administration;
2. Previously treated with DHAP;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival from registration with progression defined as time to:a. death due to any cause, orb. progression or relapse excluding progressive MRD triggering cessation of immunosuppression or DLI whichever comes first
- Secondary Outcome Measures
Name Time Method - incidence and severity of tumor lysis during first course of R-DHAP;<br /><br>- response to three courses of R-DHAP including SD;<br /><br>- percentage of successful donor searches;<br /><br>- percentage of patients who received alloSCT;<br /><br>- best response on protocol;<br /><br>- engraftment after alloSCT;<br /><br>- incidence and severity of acute and chronic GVHD;<br /><br>- toxicity;<br /><br>- overall survival (OS) from registration;<br /><br>- response of MRD to immunomodulation (either accelerated cessation of immunosuppression or DLI);<br /><br>- response of PD to recommended off-protocol immunomodulation (either accelerated cessation of immunosuppression or DLI);<br /><br>- disease status at two years after registration;<br /><br>- PFS and OS after alloSCT.