A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Arbeitsgemeinschaft medikamentoese Tumortherapie10 sites in 1 country30 target enrollmentJune 2010

ConditionsChronic Myelomonocytic Leukemia

DrugsRevlimid

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Myelomonocytic Leukemia
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Enrollment: 30
Locations: 10
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

May 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Eligibility Criteria

Inclusion Criteria

•CMML according to the WHO diagnostic criteria.
•Understand and voluntarily sign an informed consent form.
•Age \>=18 years at the time of signing the informed consent form.
•Able to adhere to the study visit schedule and other protocol requirements.
•All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
•ECOG performance status of \<= 2 at study entry.
•Laboratory test results within these ranges:
•Creatinine clearance \> 30ml/min
•AST (SGOT) and ALT (SGPT) \<= 2.5 x ULN
•Disease free of prior malignancies for \>= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

Exclusion Criteria

•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to thalidomide.
•The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
•Any prior use of lenalidomide.
•Concurrent use of other anti-cancer agents or treatments.
•Known positive for HIV or infectious hepatitis, type A, B or C.

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: 2 years

This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.

Secondary Outcomes

Number of patients achieving transfusion independence(4 years)
Number and seriousness of adverse events to evaluate safety and tolerability(4 years)
Patients achieving cytogenetic response(4 years)
Progression free survival, Overall survival(4 years)