Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

NCT ID: NCT01368757

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Chronic Myelomonocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

lenalidomide; lenalidomid

Eligibility Criteria

Inclusion Criteria

1. CMML according to the WHO diagnostic criteria.

2. Understand and voluntarily sign an informed consent form.

3. Age >=18 years at the time of signing the informed consent form.

4. Able to adhere to the study visit schedule and other protocol requirements.

5. 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.

6. ECOG performance status of <= 2 at study entry.

7. Laboratory test results within these ranges:

• Creatinine clearance > 30ml/min
• AST (SGOT) and ALT (SGPT) <= 2.5 x ULN

8. 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.

9. Female subjects of childbearing potential must:

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

10. Male subjects must

• Agree to use condoms
• Agree not to donate semen

11. All subjects must

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

Exclusion Criteria

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).

3. 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.

4. Use of any other experimental drug or therapy within 28 days of baseline.

5. Known hypersensitivity to thalidomide.

6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

7. Any prior use of lenalidomide.

8. Concurrent use of other anti-cancer agents or treatments.

9. Known positive for HIV or infectious hepatitis, type A, B or C.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Arbeitsgemeinschaft medikamentoese Tumortherapie

Principal Investigators

Josef Thaler, MD

Role: STUDY_DIRECTOR

Klinikum Wels-Grieskirchen GmbH

Sonja Burgstaller, MD

Role: STUDY_DIRECTOR

Klinikum Wels-Grieskirchen GmbH

Locations

Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III

Salzburg, Salzburg, Austria

Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie

Graz, Styria, Austria

Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie

Innsbruck, Tyrol, Austria

Krankenhaus d. Barmherzigen Schwestern Linz, Interne I

Linz, Upper Austria, Austria

Krankenhaus der Elisabethinen Linz GmbH, 1. Interne

Linz, Upper Austria, Austria

AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung

Wels, Upper Austria, Austria

MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie

Vienna, Vienna, Austria

Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie

Vienna, Vienna, Austria

LKH Feldkirch, Interne E

Feldkirch, Vorarlberg, Austria

Countries

Austria

Other Identifiers

2009-017147-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGMT_CMML 1

Identifier Type: -

Identifier Source: org_study_id