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

Phase 2

Completed

• Conditions: B-CLL; 10024324

• Registration Number: NL-OMON38321
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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;
- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>progression-free survival from registration with progression defined as time to:<br /><br>a. death due to any cause, or<br /><br>b. progression or relapse excluding progressive MRD triggering cessation of<br /><br>immunosuppression or DLI whichever comes first</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 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<br /><br>immunosuppression or DLI)<br /><br>- response of PD to recommended off-protocol immunomodulation (either<br /><br>accelerated cessation of immunosuppression or DLI)<br /><br>- disease status at two years after registration;<br /><br>- PFS and OS after alloSCT</p><br>