Back to resultsLenalidomide and Decitabine in High Grade Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide, Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplastic Syndromes, MDS
Eligibility Criteria
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 </= 2 at study entry.
- Laboratory test results within these ranges: Serum creatinine </= 2.5 mg/dL x ULN, Total bilirubin </= 2.5 mg/dL x ULN, AST (SGOT) and ALT (SGPT) </= 3 x ULN.
- 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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Arm Description
Lenalidomide (5mg) and Decitabine
Lenalidomide (10 mg) and Decitabine
Lenalidomide (15 mg) and Decitabine
Lenalidomide (20 mg) and Decitabine
Lenalidomide (25 mg) and Decitabine
Outcomes
Primary Outcome Measures
Maximally tolerated dose (MTD)as defined by the protocol
Secondary Outcome Measures
response duration
effect on cytogenetic abnormalities
Full Information
NCT ID
NCT00828802
First Posted
January 22, 2009
Last Updated
September 6, 2013
Sponsor
Duke University
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00828802
Brief Title
Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes
Official Title
A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out what dose of lenalidomide is safe to use in combination with decitabine when given in people with myelodysplastic syndrome.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Myelodysplastic Syndromes, MDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Lenalidomide (5mg) and Decitabine
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Lenalidomide (10 mg) and Decitabine
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Lenalidomide (15 mg) and Decitabine
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Lenalidomide (20 mg) and Decitabine
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Lenalidomide (25 mg) and Decitabine
Intervention Type
Drug
Intervention Name(s)
Lenalidomide, Decitabine
Other Intervention Name(s)
revlimid, Dacogen
Intervention Description
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Primary Outcome Measure Information:
Title
Maximally tolerated dose (MTD)as defined by the protocol
Time Frame
Cycle 1
Secondary Outcome Measure Information:
Title
response duration
Time Frame
2 years
Title
effect on cytogenetic abnormalities
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 </= 2 at study entry.
Laboratory test results within these ranges: Serum creatinine </= 2.5 mg/dL x ULN, Total bilirubin </= 2.5 mg/dL x ULN, AST (SGOT) and ALT (SGPT) </= 3 x ULN.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos de Castro, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes
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