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A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT01379274
Recruitment Status : Terminated (Loss of funding.)
First Posted : June 23, 2011
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Jamile Shammo, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE June 17, 2011
First Posted Date  ICMJE June 23, 2011
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
safety and tolerability of revlimid and azacitidine combination [ Time Frame: 2 -3 years ]
To determine the number of subjects who develop grade 4 toxicity while on combination therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
To determine the response rate to the combination of lenalidomide and low dose azacitidine in patients with low - intermediate-1 risk MDS enalidomide) monotherapy [ Time Frame: 2 -3 years ]
Change History Complete list of historical versions of study NCT01379274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes
Official Title  ICMJE A Phase II Trial of Revlimid® (Lenalidomide) and Low Dose Vidaza® (Azacitidine) in Patients With Low - Intermediate-1 Risk Myelodysplastic Syndromes
Brief Summary

This phase II study will evaluate the safety and efficacy of combining two active agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination therapy will result in higher response rates, and potentially longer response duration than that achieved with either agent.

STUDY OBJECTIVES:

Primary:

To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy

Secondary:

To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza® (azacitidine), as defined by the IWG 2006 Revised Response Criteria

Detailed Description

Eligibility criteria

  1. Understand and voluntarily sign an informed consent form.
  2. Age 18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Diagnosis of low- or intermediate-1-risk IPSS (see Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33.

    Pathologic diagnosis via pathology performed at Rush University Medical Center or made available to Rush from outside institution.

  5. Prior treatment with < 3 cycles (84 days) of Revlimid® (lenalidomide) are eligible for enrollment regardless of response.
  6. ECOG performance status of 2 at study entry (see Appendix II).
  7. Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
  8. Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
  9. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
  10. Serum creatinine levels < 1.5 x ULN
  11. Absolute neutrophil count > 1000/mm³
  12. Platelet count > 30,000/mm³
  13. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE MDS
Intervention  ICMJE Drug: Lenalidomide and azacitidine combination

lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.

Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy.

Other Names:
  • lenalidomide
  • Azacitidine
Study Arms  ICMJE Experimental: lenalidomide and azacitidine combination
Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.
Intervention: Drug: Lenalidomide and azacitidine combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 26, 2013)
2
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2011)
55
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Patients with low to Int-1 risk MDS

  1. ECOG performance status of < 2 at study entry (see Appendix II).
  2. Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
  3. Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
  4. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
  5. Serum creatinine levels 1.5 x ULN
  6. Absolute neutrophil count > 1000/mm³
  7. Platelet count > 30,000/mm³
  8. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  9. Females of childbearing potential (FCBP)† must have a negative serum or urine

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 Revlimid® (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 lenalidomide, azacitidine, or mannitol.
  6. Any prior use of Vidaza® (azacitidine).
  7. Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
  8. Concurrent use of other anti-cancer agents or treatments.
  9. Known positive for HIV or infectious hepatitis, type B or C.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01379274
Other Study ID Numbers  ICMJE MDS 2008-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamile Shammo, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Jamile M Shammo, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP