Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation
Contains fulltext : 95663.pdf (Publisher’s version ) (Closed access) We present results of a phase 3 randomized trial of autografting in chronic lymphocytic leukemia versus observation for responding patients after first- or second-line treatment. The primary objective was to demonstrate that autografting improves the 5-year event-free survival (EFS) from 30% to 50%. There were 223 enrolled patients, 72% men and 28% women, 83% after first and 17% after second-line treatment. Binet stages were progressive A 13%, B 67%, C 20%; at randomization, 59% were in complete remission, and 41% in less than complete remission. Patients were randomized between autografting (n = 112) and observation (n = …
AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTOHSCT) IN CLL: FIRST RESULTS OF AN EBMT RANDOMIZED TRIAL COMPARING AUTOTRANSPLANT VERSUS WAIT AND WATCH
Abstract Abstract 877 This phase-III randomized EBMT-intergroup trial studied the impact of a consolidating autoHSCT vs no consolidation for patients with CLL in Binet stage A progressive, B or C , in CR, nodular PR or VGPR after first or second line therapy. The primary objective was to show that autoHSCT increased the 5-year progression-free survival (PFS) by 30%. Although it had been calculated that 270 patients were to be randomized, the study was terminated by the steering committee in July 2007 due to poor accrual. Here we present a first analysis based on 69% of expected follow-up forms. Results: Between November 2001 and July 2007, 223 patients were enrolled (SFGM-TC/FCLLG n=98, MRC…
Alemtuzumab Plus Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allogeneic Transplantation in Ultra High-Risk CLL: Updated Results From a Phase II Study of the Gcllsg and fcgcll/MW
Abstract Abstract 716 CLL patients characterized by 17p-, TP53 mutation or refractoriness to fludarabine (F)-based therapy show a very poor prognosis (“ultra high-risk CLL”). Although alemtuzumab (A) showed efficacy in these cohorts, the rate and duration of remissions remain unsatisfactory. Aim of the CLL2O study was to achieve higher overall response rates (ORR) by adding high-dose dexamethasone (D) to A during induction and investigating the consolidation effect of prolonged A or allogeneic stem-cell transplantation (allo-SCT), respectively. Induction treatment consisted of subcutaneous A, 30 mg weekly × 3 for 28 days, combined with oral D, 40 mg on days 1–4 and 15–18, and prophylactic p…
FCR front-line therapy and quality of life in patients with chronic lymphocytic leukemia.
The chemoimmunotherapy FCR (fludarabine and cyclophosphamide with rituximab) is the standard first-line treatment for physically fit chronic lymphocytic leukemia (CLL) patients. To assess the risks and benefits, we investigated health-related quality of life (HRQOL). 817 untreated CLL patients received either FC or FCR within the GCLLSG CLL8 trial. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 was sent to all patients at baseline, after 3, 6, and 12 months and then yearly as follow-up. A total of 769 (94%) of 817 patients completed at least one questionnaire. Comparing HRQOL of CLL patients with the general German population, CLL patients' …