EUCTR2007-005487-28-NL
Active, not recruiting
Phase 1
Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory CLL - HOVON 88 C
HOVON Foundation0 sites50 target enrollmentAugust 13, 2008
ConditionsChronic lymphocytic leukemiaMedDRA version: 14.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsMabthera
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic lymphocytic leukemia
- Sponsor
- HOVON Foundation
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
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.
- •Are the trial subjects under 18? no
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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