Trials / Unknown
UnknownNCT01368757
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Revlimid | Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached. Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen. |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2011-06-08
- Last updated
- 2015-03-09
Locations
10 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT01368757. Inclusion in this directory is not an endorsement.