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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Chronic Myelomonocytic Leukemia

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Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Josef Thaler, MD

Investigator Role:

Study Director

Investigator Affiliation:

Klinikum Wels-Grieskirchen GmbH


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Chronic Myelomonocytic Leukemia
  • Chronic myelomonocytic leukemia
  • CMML
  • Lenalidomide
  • Revlimid
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Acute