Refractory or relapsed Chronic Lymphocytic Leukemia
Conditions
Interventions
All patients will be treated with at least three courses of R-DHAP (rituximab, dexamethasone, cisplatin, cytarabin, 4 days every 4 weeks) while a HLA-identical donor is being searched. Patients with a
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
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; 3. Age 18-70 years inclusive; 4. WHO performance status ¡Ü 2; 5. HCT-CI ¡Ü 2; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Intolerance to exogenous protein administration; 2. Previously treated with DHAP; 3. Richter.s transformation; 4. Suspected or documented CNS involvement by CLL; 5. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); 6. Severe pulmonary dysfunction (CTCAE grade III-IV; 7. Severe neurological or psychiatric disease; 8. Significant hepatic dysfunction (serum bilirubin or transaminases ¡Ý 3 times upper limit of normal) except when caused by leukemic infiltration; 9. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration); 10. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma; 11. Active, uncontrolled infections; 12. Patient known to be HIV-positive; 13. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 14. Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - incidence and severity of tumor lysis during first course of R-DHAP; - response to three courses of R-DHAP including SD; - percentage of successful donor searches; - percentage of patients who received alloSCT; - best response on protocol; - engraftment after alloSCT; - incidence and severity of acute and chronic GVHD; - toxicity; - overall survival (OS) from registration; - response of MRD to immunomodulation (either accelerated cessation of immunosuppression or DLI); - response of PD to recommended off-protocol immunomodulation (either accelerated cessation of immunosuppression or DLI); - disease status at two years after registration; - PFS and OS after alloSCT. | — |
Contacts
Public ContactM. Gelder, van
AZ Maastricht Department of Internal Medicine P.O. Box 5800
Outcome results
None listed