Back to results

A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

Primary Purpose

MDS

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lenalidomide and azacitidine combination

About this trial

This is an interventional treatment trial for MDS focused on measuring MDS, Low risk disease, IPSS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

ECOG performance status of < 2 at study entry (see Appendix II).
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.
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.
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
Serum creatinine levels 1.5 x ULN
Absolute neutrophil count > 1000/mm³
Platelet count > 30,000/mm³
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 (FCBP)† must have a negative serum or urine

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide).
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.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to lenalidomide, azacitidine, or mannitol.
Any prior use of Vidaza® (azacitidine).
Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV or infectious hepatitis, type B or C.

Sites / Locations

Rush University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lenalidomide and azacitidine combination

Arm Description

Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.

Outcomes

Primary Outcome Measures

Safety and Tolerability of Revlimid and Azacitidine Combination

To determine the number of subjects who develop grade 4 toxicity while on combination therapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT01379274

First Posted

June 17, 2011

Last Updated

November 2, 2020

Sponsor

Rush University Medical Center

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01379274

Brief Title

A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

Official Title

A Phase II Trial of Revlimid® (Lenalidomide) and Low Dose Vidaza® (Azacitidine) in Patients With Low - Intermediate-1 Risk Myelodysplastic Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Loss of funding.

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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. 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. Prior treatment with < 3 cycles (84 days) of Revlimid® (lenalidomide) are eligible for enrollment regardless of response. ECOG performance status of 2 at study entry (see Appendix II). 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. 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. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN. Serum creatinine levels < 1.5 x ULN Absolute neutrophil count > 1000/mm³ Platelet count > 30,000/mm³ All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MDS

Keywords

MDS, Low risk disease, IPSS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lenalidomide and azacitidine combination

Arm Type

Experimental

Arm Description

Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide and azacitidine combination

Other Intervention Name(s)

lenalidomide, Azacitidine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and Tolerability of Revlimid and Azacitidine Combination

Description

To determine the number of subjects who develop grade 4 toxicity while on combination therapy.

Time Frame

Study was closed and outcome unable to be measured.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with low to Int-1 risk MDS ECOG performance status of < 2 at study entry (see Appendix II). 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. 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. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN. Serum creatinine levels 1.5 x ULN Absolute neutrophil count > 1000/mm³ Platelet count > 30,000/mm³ 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 (FCBP)† must have a negative serum or urine Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide). 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. Use of any other experimental drug or therapy within 28 days of baseline. Known hypersensitivity to lenalidomide, azacitidine, or mannitol. Any prior use of Vidaza® (azacitidine). Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles). Concurrent use of other anti-cancer agents or treatments. Known positive for HIV or infectious hepatitis, type B or C.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamile M Shammo, MD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

We'll reach out to this number within 24 hrs