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Also known as Clolar, VP-16, Cytoxan, PEGaspar-aginase, Oncovin
Clofarabine incorporated into a 5-drug regimen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Clofarabine | EXPERIMENTAL | Patients received a maximum of 2 cycles of the intravenous (IV) 5-drug regimen (clofarabine, etoposide,cyclophosphamide, PEG-asparaginase, and vincristine) plus intrathecal methotrexate, and then entered follow-up. Patients who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and patients who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Clofarabine incorporated into a 5-drug regimen | DRUG | Clofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine |
Inclusion Criteria: * Be in first relapse with \>25% blasts in the bone marrow with a duration of first remission of ≥6 months and no longer in the intensive phase(s) of initial ALL therapy (e.g., patients who are in the maintenance or continuation phases of therapy \[or beyond\] and who have compl...
It is being studied for the treatment of pediatric acute lymphoblastic leukemia (ALL) in children. The regimen combines clofarabine with etoposide, cyclophosphamide, PEG-asparaginase, and vincristine. It is an investigational approach in early clinical development, not an approved therapy for this use.
Clofarabine is a small molecule inhibitor that targets DNA polymerases, including POLA1, POLD1, POLD2, POLD3, POLD4, and POLE. By inhibiting these enzymes, it interferes with DNA synthesis and repair in leukemia cells. This mechanism underlies its evaluation in pediatric acute lymphoblastic leukemia.
Sanofi (ticker SNY) is the developer associated with clofarabine, the small molecule component of this five-drug regimen. The regimen also includes etoposide, cyclophosphamide, PEG-asparaginase, and vincristine. Sanofi is the company linked to the clofarabine asset in this program.
It is in Phase 1 development. The single registered trial, NCT00991133, was a Phase 1 safety and tolerability study in pediatric acute lymphoblastic leukemia and is now completed. The drug is investigational and has not been approved for this indication.
One trial is registered: NCT00991133, titled a safety and tolerability study of clofarabine, etoposide, cyclophosphamide, PEG-asparaginase, and vincristine in pediatric acute lymphoblastic leukemia. It was a Phase 1, uncontrolled study that enrolled 8 patients in the United States and is completed.
Clofarabine is the active small molecule component of this five-drug regimen, which also contains etoposide, cyclophosphamide, PEG-asparaginase, and vincristine. The regimen is studied as a combination rather than clofarabine alone. Clofarabine is identified by the ChEMBL ID CHEMBL1750.