NL-OMON38321
Completed
Phase 2
Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory CLL - HOVON 88 C
HOVO0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- B-CLL
- Sponsor
- HOVO
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- B\-CLL confirmed according to WHO Classification
- •\- 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;
- •\- Age 18\-70 years inclusive;
- •\- WHO performance status \<\= 2 (see appendix E);;\- HCT\-CI \<\= 2 (see appendix F);
- •\- Written informed consent.
Exclusion Criteria
- •\- Intolerance to exogenous protein administration
- •\- Previously treated with DHAP
- •\- Richter\*s transformation;
- •\- Suspected or documented CNS involvement by CLL;
- •\- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
- •\- Severe pulmonary dysfunction (CTCAE grade III\-IV, see appendix D);
- •\- Severe neurological or psychiatric disease;
- •\- Significant hepatic dysfunction (serum bilirubin or transaminases \>\= 3 times upper limit of normal) except when caused by leukemic infiltration;
- •\- Significant renal dysfunction (creatinine clearance \< 30 ml/min after rehydration);
- •\- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
Outcomes
Primary Outcomes
Not specified
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