Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie (Other)

Overall Status

Unknown status

CT.gov ID

NCT01368757

Collaborator

Celgene Corporation (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelomonocytic Leukemia	Drug: Revlimid	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

May 1, 2015

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) [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 Outcome Measures

Number and seriousness of adverse events to evaluate safety and tolerability [4 years]
For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
Number of patients achieving transfusion independence [4 years]
Phase II
Progression free survival, Overall survival [4 years]
Phase II
Patients achieving cytogenetic response [4 years]
Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Female subjects of childbearing potential must:

Understand the study drug is expected to have a teratogenic risk
Agree to use two effective contraception

Male subjects must

Agree to use condoms
Agree not to donate semen

All subjects must

Agree to abstain from donating blood
Agree not to share study drug with another person

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus d. Barmherzigen Schwestern Linz, Interne I	Linz	Oberösterreich	Austria	4010
2	Krankenhaus der Elisabethinen Linz GmbH, 1. Interne	Linz	Oberösterreich	Austria	4010
3	AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie	Linz	Oberösterreich	Austria	4021
4	Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung	Wels	Oberösterreich	Austria	4600
5	Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie	Graz	Steiermark	Austria	8036
6	Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie	Innsbruck	Tirol	Austria	6020
7	LKH Feldkirch, Interne E	Feldkirch	Vorarlberg	Austria	6807
8	Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III	Salzburg		Austria	5020
9	MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie	Wien		Austria	1090
10	Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie	Wien		Austria	1140