Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes
This study is ongoing, but not recruiting participants.
Sponsor:
Duke University
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00828802
First received: January 22, 2009
Last updated: October 4, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: Lenalidomide, Decitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Maximally tolerated dose (MTD)as defined by the protocol [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- effect on cytogenetic abnormalities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Lenalidomide (5mg) and Decitabine
|
Drug: Lenalidomide, Decitabine
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)
Other Names:
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Experimental: Cohort 2
Lenalidomide (10 mg) and Decitabine
|
Drug: Lenalidomide, Decitabine
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)
Other Names:
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Experimental: Cohort 3
Lenalidomide (15 mg) and Decitabine
|
Drug: Lenalidomide, Decitabine
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)
Other Names:
|
|
Experimental: Cohort 4
Lenalidomide (20 mg) and Decitabine
|
Drug: Lenalidomide, Decitabine
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)
Other Names:
|
|
Experimental: Cohort 5
Lenalidomide (25 mg) and Decitabine
|
Drug: Lenalidomide, Decitabine
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)
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828802
Locations
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Celgene Corporation
Investigators
| Principal Investigator: | Carlos de Castro, MD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00828802 History of Changes |
| Other Study ID Numbers: | Pro00010179 |
| Study First Received: | January 22, 2009 |
| Last Updated: | October 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Myelodysplastic Syndromes MDS |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Decitabine Lenalidomide Thalidomide Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013