Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory C

Phase 1

• Conditions: Chronic lymphocytic leukemia; MedDRA version: 14.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005487-28-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-13
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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;
- Active, uncontrolled infections;
- Patient known to be HIV-positive;
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified