Lenalidomide and Decitabine in High Grade Myelodysplastic Syndromes

NCT00828802 | Completed Phase 1

• 1 other identifier: Pro00010179
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; MDS

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated dose (MTD)as defined by the protocol

  Cycle 1

Secondary Outcomes (2)

• response duration

  2 years

• effect on cytogenetic abnormalities

  6 months

Study Arms (5)

Cohort 1

EXPERIMENTAL

Lenalidomide (5mg) and Decitabine

Drug: Lenalidomide, Decitabine

Cohort 2

EXPERIMENTAL

Lenalidomide (10 mg) and Decitabine

Drug: Lenalidomide, Decitabine

Cohort 3

EXPERIMENTAL

Lenalidomide (15 mg) and Decitabine

Drug: Lenalidomide, Decitabine

Cohort 4

EXPERIMENTAL

Lenalidomide (20 mg) and Decitabine

Drug: Lenalidomide, Decitabine

Cohort 5

EXPERIMENTAL

Lenalidomide (25 mg) and Decitabine

Drug: Lenalidomide, Decitabine

Interventions

Lenalidomide, Decitabine DRUG

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)

Also known as: revlimid, Dacogen

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide; Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

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; Azacitidine; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Carlos de Castro, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

US (1)