CLL: Studien
Deutsche CLL-Studiengruppe = G CLL SG
| Studie (Quelle) | Phase | Schema | Patientenzahl | Alter | CR (%) | OR (%) | PFS/Monate |
| Fischer(5) | II | BR | 117 | 64 | 23 | 88 | 34 |
| Kay(18) | II | PCR | 65 | 63 | 41 | 91 | 33 |
| CALGB 9712(16,17) | II | FR | 104 | 63 | 38 | 84 | 42 |
| MDACC(15,20) | II | FCR | 224 | 57 | 72 | 96 | 80 |
| Knauf (1) | III | Chlor | 157 | 64 | 2 | 31 | 8 |
| B | 162 | 63 | 31 | 68 | 22 | ||
| LRF CLL4(8) | III | Chlor | 366 | 65 | 7 | 72 | 20 |
| F | 181 | 64 | 15 | 80 | 23 | ||
| FC | 182 | 65 | 38 | 95 | 45 | ||
| E2997(9) | III | F | 137 | 61 | 5 | 60 | 19 |
| FC | 141 | 61 | 23 | 74 | 32 | ||
| GCLLSG CLL5(7) | III | F | 182 | 59 | 7 | 83 | 20 |
| FC | 180 | 58 | 24 | 95 | 48 | ||
| GCLLSG CLL8(2) | III | FC | 409 | 61 | 22 | 80 | 33 |
| FCR | 408 | 61 | 44 | 90 | 52 |
Multizentrische Phase II-Studie von Bendamustin in Kombination mit Rituximab bei Patienten mit rezidivierter Chronisch Lymphatischer Leukämie
Prüfung der Wirksamkeit von Darbepoetin alfa bei chemotherapierten Patienten mit chronischer lymphatischer Leukämie und Komorbidität. Randomisierte, kontrollierte , multizentrische Phase III-Studie
Randomisierte Phase III - Studie : frühe Therapie mit Fludarabin/Cyclophosphamid plus Rituximab gegen keine Therapie(Beobachtung) in Stadium BINET A bei Patienten mit Hoch-Risiko einer Progression
GAIA-Trial: Standard Chemoimmunotherapie versus Rituximab + Venetoclax versus Obinutuzumab + Venetoclax versus Obinutuzumab + Ibrutinib + Venetoclax
Bei rezidivierender CLL verbessert Idelalisib das Ergebnis einer alleinigen Behandlung mit Retuximab.
Vergleich von Ibrutinib versus Ofatumumab bei rezidivierter oder refraktärer CLL.
Mit dem BCL-2-IH Venetoclax und Rituximab konnte bei rezidivierter oder resistenter CLL ein signifikant längeres RFS erzielt werden als mit Bendamustin und Rituximab!
Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia.
J Clin Oncol 27:4378-4384, 2009
2. Hallek M, Fischer K, Fingerle-Rowson G, et al:
Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: A randomised, open-label, phase 3 trial.
Lancet 376:1164-1174, 2010
3. Robak T, Dmoszynska A, Solal-Ce´ ligny P, et al:
Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia.
J Clin Oncol 28:1756-1765, 2010
4. Fischer K, Cramer P, Busch R, et al:
Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: A multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group.
J Clin Oncol 29:3559-3566, 2011
5. Fischer K, Cramer P, Busch R, et al:
Bendamustine combined with rituximab for previously untreated patients with chronic lymphocytic leukemia: A multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group.
J Clin Oncol 30:3209-3216, 2012
6. Rai KR, Peterson BL, Appelbaum FR, et al:
Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia.
N Engl J Med 343:1750-1757, 2000
7. Eichhorst BF, Busch R, Hopfinger G, et al:
Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia.
Blood 107:885-891, 2006
8. Catovsky D, Richards S, Matutes E, et al:
Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): A randomised controlled trial.
Lancet 370:230-239, 2007
9. Flinn IW, Neuberg DS, Grever MR, et al:
Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997.
J Clin Oncol 25:793-798, 2007
10. Hillmen P, Skotnicki AB, Robak T, et al:
Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia.
J Clin Oncol 25:5616-5623, 2007
11. O’Brien S, Wierda WG, Faderl S, et al:
FCR-3 as frontline therapy for patients with chronic lymphocytic leukemia (CLL).
47th ASH Annual Meeting and Exposition, Atlanta, GA, December 10-13, 2005 (abstr 2117)
12. Faderl S, Wierda W, O’Brien S, et al:
Fludarabine, cyclophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL 70 years.
Leuk Res 34:284-288, 2010
13. Parikh SA, Keating MJ, O’Brien S, et al:
Frontline chemoimmunotherapy with fludarabine, cyclophosphamide, alemtuzumab, and rituximab for high-risk chronic lymphocytic leukemia.
Blood 118:2062-2068, 2011
14. Ferrajoli A, Faderl S, O’Brien S, et al:
Experience with fludarabine, cyclophosphamide, rituximab (FCR) plus GM-CSF in frontline therapy for chronic lymphocytic leukemia (CLL).
50th ASH Annual Meeting and Exposition, San Francisco, CA, December 6-9, 2008 (abstr 3173)
15. Tam CS, O’Brien S, Wierda W, et al:
Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia.
Blood 112:975-980, 2008
16. Byrd JC, Peterson BL, Morrison VA, et al:
Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: Results from Cancer and Leukemia Group B 9712 (CALGB 9712).
Blood 101:6-14, 2003
17. Woyach JA, Ruppert AS, Heerema NA, et al:
Chemoimmunotherapy with fludarabine and rituximab produces extended overall survival and progressionfree survival in chronic lymphocytic leukemia: Long-term follow-up of CALGB study 9712.
J Clin Oncol 29:1349-1355, 2011
18. Kay NE, Geyer SM, Call TG, et al:
Combination chemoimmunotherapy with pentostatin, cyclophosphamide, and rituximab shows significant clinical activity with low accompanying toxicity in previously untreated B chronic lymphocytic leukemia.
Blood 109:405-411, 2007
19. Keating MJ, O’Brien S, Albitar M, et al:
Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia.
J Clin Oncol 23:4079-4088, 2005
20. Extermann M, Overcash J, Lyman GH, et al:
Comorbidity and functional status are independent in older cancer patients.
J Clin Oncol 16:1582-1587,1998
21. O’Brien S, Burger JA, Blum KA, et al:
The Bruton’s tyrosine kinase (BTK) inhibitor PCI-32765 induces durable responses in relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Follow-up of a phase Ib/II study.
53rd ASH Annual Meeting and Exposition, San Diego, CA, December 10-13, 2011 (abstr 983)
22. Furman RR, Byrd JC, Brown JR, et al:
CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-kinase P110, demonstrates clinical activity and pharmacodynamic effects in patients with relapsed or refractory chronic lymphocytic leukemia.
52nd ASH Annual Meeting and Exposition, Orlando, FL, December 4-7, 2010 (abstr 55)