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A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes

Phase 1
18 Years
Open (Enrolling)
Myelodysplastic Syndromes

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Trial Information

A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes

Myelodysplastic syndrome (MDS) is a group of different kinds of stem cell abnormalities. It
is characterized by low blood counts and abnormal blood cell formation. These abnormal blood
cells can cause fatigue, shortness of breath, infection, and bleeding. There is significant
risk of developing acute leukemia in this disorder.

The only known curative therapy is an allogeneic bone marrow transplant of which the vast
majority of patients with this disorder are not candidates. Currently three drugs have been
approved for the treatment of MDS: azacytidine, decitabine and lenalidomide for low grade
patients with a chromosome 5q abnormality. Azacytidine and decitabine have been
demonstrated to improve blood counts, improve the quality of life, and decrease the risk of
progression to AML or death in a sizable minority of MDS patients. A recent study of MDS
patients who had responded clinically to decitabine revealed that their bone marrow biopsies
still showed stromal abnormalities such as increased angiogenesis. Lenalidomide acts at the
level of the stromal - marrow cell interaction. It is hypothesized that the combination of
decitabine with lenalidomide may show synergistic results.

Inclusion 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.

- Myelodysplastic syndrome (documented by bone marrow biopsy) with IPSS score of Int-2
or High risk.

- All previous MDS therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 28 days prior to treatment in this study.

- ECOG performance status of
- Laboratory test results within these ranges: Serum creatinine Total bilirubin
- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®.

- Females of childbearing potential must have a negative serum pregnancy test within
10-14 days prior to and again within 24 hours of prescribing lenalidomide and must
either commit to continued abstinence from heterosexual intercourse or begin TWO
acceptable methods of birth control, one highly effective method and one additional
effective method AT THE SAME TIME, at least 28 days before she starts taking
lenalidomide. Must also agree to ongoing pregnancy testing.

- Men must agree to use a latex condom during sexual contact even if they have had a
successful vasectomy.

- Disease free of prior malignancies for >/= 3 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, localized prostate cancer,
or carcinoma "insitu" of the cervix or breast.

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric

- Pregnant or breast feeding females.

- 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.

- Known hypersensitivity or reaction to thalidomide, lenalidomide or decitabine.

- Any prior use of lenalidomide.

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

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

- History of thromboembolic event within past 6 months prior to enrollment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximally tolerated dose (MTD)as defined by the protocol

Outcome Time Frame:

Cycle 1

Safety Issue:


Principal Investigator

Carlos de Castro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

August 2014

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • MDS
  • Myelodysplastic Syndromes
  • Preleukemia



Duke University Medical CenterDurham, North Carolina  27710