Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Chronic Myelomonocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01368757
• Other study ID #: AGMT_CMML 1
• Secondary ID: 2009-017147-33
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 9, 2011
• Last updated: March 6, 2015
• Start date: June 2010
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic

Intervention

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.

Locations

Country	Name	City	State
Austria	LKH Feldkirch, Interne E	Feldkirch	Vorarlberg
Austria	Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie	Graz	Steiermark
Austria	Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie	Innsbruck	Tirol
Austria	AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie	Linz	Oberösterreich
Austria	Krankenhaus d. Barmherzigen Schwestern Linz, Interne I	Linz	Oberösterreich
Austria	Krankenhaus der Elisabethinen Linz GmbH, 1. Interne	Linz	Oberösterreich
Austria	Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III	Salzburg
Austria	Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung	Wels	Oberösterreich
Austria	Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie	Wien
Austria	MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Celgene Corporation

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	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.	2 years	Yes
Secondary	Number and seriousness of adverse events to evaluate safety and tolerability	For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.	4 years	Yes
Secondary	Number of patients achieving transfusion independence	Phase II	4 years	No
Secondary	Progression free survival, Overall survival	Phase II	4 years	No
Secondary	Patients achieving cytogenetic response	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	4 years	No