Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

NCT01368757 | Unknown Phase 1

• 2 other identifiers: AGMT_CMML 12009-017147-33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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

Keywords

Chronic myelomonocytic leukemia; CMML; Lenalidomide; Revlimid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number and seriousness of adverse events to evaluate safety and tolerability

  4 years

• Number of patients achieving transfusion independence

  4 years

• Progression free survival, Overall survival

  4 years

• Patients achieving cytogenetic response

  4 years

Interventions

Revlimid DRUG

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.

Also known as: lenalidomide, lenalidomid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead
• Celgene Corporation: collaborator

Study Sites (10)

Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III

Salzburg, Salzburg, 5020, Austria

Location

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

Graz, Styria, 8036, Austria

Location

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

Innsbruck, Tyrol, 6020, Austria

Location

Krankenhaus d. Barmherzigen Schwestern Linz, Interne I

Linz, Upper Austria, 4010, Austria

Location

Krankenhaus der Elisabethinen Linz GmbH, 1. Interne

Linz, Upper Austria, 4010, Austria

Location

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

Linz, Upper Austria, 4021, Austria

Location

Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung

Wels, Upper Austria, 4600, Austria

Location

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

Vienna, Vienna, 1090, Austria

Location

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

Vienna, Vienna, 1140, Austria

Location

LKH Feldkirch, Interne E

Feldkirch, Vorarlberg, 6807, Austria

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Josef Thaler, MD

  Klinikum Wels-Grieskirchen GmbH

  STUDY DIRECTOR

• Sonja Burgstaller, MD

  Klinikum Wels-Grieskirchen GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: June 8, 2011
• Study Start: June 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

AU (10)