New agents in clinical trials for treatment of chronic lymphocytic leukemia (CLL).
| Agent . | Type . | Route . | Doses/schedule . | Stage of development in CLL . |
|---|---|---|---|---|
| Abbreviations: FCR, fludarabine, cyclophosphamide, rituximab | ||||
| Bendamustine | Alkylating agent nucleoside analog? | IV | 70–100 mg/m2 d x 2 q 4 wks | Approved by FDA 3/08 |
| Lumiliximab | Primatized antibody to CD23 | IV | 500 mg/m2 q 4 weeks with chemotherapy | Pivotol trial ongoing FCR ± lumiliximab |
| Ofatumumab | Humanized antibody to CD20 | IV | Dose 1: 500 mg/m2 Doses 2–7: 2000 mg/m2 | 51% response rate in fludarabine/ alemtuzumab refractory CLL, to be submitted to FDA |
| Lenalidomide | IMID | PO | 5–25 mg daily continuously or 3 of 4 weeks | Dose finding study nearing completion |
| Flavopiridol | Cyclin-dependent kinase (CDK) inhibitor | IV | 30 mg/m2 IV bolus 30–50 mg/m2 IV for 4 hrs | Pivotal trial in fludarabine-refractory CLL ongoing |
| SNS-032 | CDK inhibitor | IV | Loading dose then 6-hr infusion q 3 weeks | Phase I ongoing |
| Oblimersen | BCL-2 antisense | IV | 3 mg/kg/d as continuous infusion 7 days with chemotherapy | Pivotal randomized trial of FCR ± oblimersen completed, under FDA review |
| Obatoclax | BH3-mimetic | IV | 60 mg over 24 hrs, 1–4 days 45 mg over 3 hrs weekly or days 1, 4, 8, 11 | Fludarabine, rituximab and obatoclax trial ongoing |
| ABT-263 | BH3-mimetic | PO | Daily | Phase I ongoing |
| Enzastaurin | Protein kinase C inhibitor | PO | 500 mg daily | Phase IA ongoing |
| BIIB021 | HSP-90 inhibitor | PO | 21 of 28 days | Phase I ongoing |
| Dasatinib | SRC-inhibitor | PO | 50–140 mg daily | Phase II trials ongoing |
| TRU16 | Small modular immune pharmaceutic anti-CD37 | IV | Weekly x 4 | Phase I ongoing |
| Agent . | Type . | Route . | Doses/schedule . | Stage of development in CLL . |
|---|---|---|---|---|
| Abbreviations: FCR, fludarabine, cyclophosphamide, rituximab | ||||
| Bendamustine | Alkylating agent nucleoside analog? | IV | 70–100 mg/m2 d x 2 q 4 wks | Approved by FDA 3/08 |
| Lumiliximab | Primatized antibody to CD23 | IV | 500 mg/m2 q 4 weeks with chemotherapy | Pivotol trial ongoing FCR ± lumiliximab |
| Ofatumumab | Humanized antibody to CD20 | IV | Dose 1: 500 mg/m2 Doses 2–7: 2000 mg/m2 | 51% response rate in fludarabine/ alemtuzumab refractory CLL, to be submitted to FDA |
| Lenalidomide | IMID | PO | 5–25 mg daily continuously or 3 of 4 weeks | Dose finding study nearing completion |
| Flavopiridol | Cyclin-dependent kinase (CDK) inhibitor | IV | 30 mg/m2 IV bolus 30–50 mg/m2 IV for 4 hrs | Pivotal trial in fludarabine-refractory CLL ongoing |
| SNS-032 | CDK inhibitor | IV | Loading dose then 6-hr infusion q 3 weeks | Phase I ongoing |
| Oblimersen | BCL-2 antisense | IV | 3 mg/kg/d as continuous infusion 7 days with chemotherapy | Pivotal randomized trial of FCR ± oblimersen completed, under FDA review |
| Obatoclax | BH3-mimetic | IV | 60 mg over 24 hrs, 1–4 days 45 mg over 3 hrs weekly or days 1, 4, 8, 11 | Fludarabine, rituximab and obatoclax trial ongoing |
| ABT-263 | BH3-mimetic | PO | Daily | Phase I ongoing |
| Enzastaurin | Protein kinase C inhibitor | PO | 500 mg daily | Phase IA ongoing |
| BIIB021 | HSP-90 inhibitor | PO | 21 of 28 days | Phase I ongoing |
| Dasatinib | SRC-inhibitor | PO | 50–140 mg daily | Phase II trials ongoing |
| TRU16 | Small modular immune pharmaceutic anti-CD37 | IV | Weekly x 4 | Phase I ongoing |