Trials / Unknown
UnknownNCT03613428
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Sichuan University · Academic / Other
- Sex
- All
- Age
- 13 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ruxolitinib | Dose escalation up to 80 mg administered orally |
| DRUG | Vincristine | 1.4 mg/m2 i.v. weekly for 4 weeks |
| DRUG | Prednisone | 1 mg/kg orally 5 consecutive days per week for 4 weeks. |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2020-12-30
- Completion
- 2021-03-30
- First posted
- 2018-08-03
- Last updated
- 2018-08-03
Source: ClinicalTrials.gov record NCT03613428. Inclusion in this directory is not an endorsement.