Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01900509 | Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies | PHASE1 | COMPLETED | 16 | — | — | Aug 1, 2013 | May 1, 2016 | Mar 22, 2017 | 1 | United States |
Establish MTD of bendamustine in combination with clofarabine and etoposide.
Characterize safety profile and DLTs of bendamustine in combination with clofarabine and etoposide
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | All participants who meet eligibility for this study will follow the same treatment regimen. INTERVENTIONS: bendamustine, clofarabine, etoposide (or etoposide phosphate), dexamethasone. |
| Name | Type | Description |
|---|---|---|
| Bendamustine | DRUG | Route of administration: intravenously (IV) over approximately 60 minutes, days 1-5. |
| Clofarabine | DRUG | Route of administration: IV days 1-5. |
| Etoposide | DRUG | Route of administration: IV days 1-5. |
| Etoposide phosphate | DRUG | Route of administration: Used in substitution for etoposide in participants who experience allergic reaction, Etopophos® will be administered IV. |
| Dexamethasone | DRUG | Route of administration: three times daily orally (by mouth), days 1-5. |
INCLUSION CRITERIA * Participants with Hodgkin or Non-Hodgkin lymphoma must meet one of the following criteria: (a) Relapsing disease in 2nd or greater relapse and measurable disease, or (b) Refractory disease failing to achieve complete remission (CR) with \> 2 induction or re-induction attempts. ...