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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Low and Intermediate 1 Risk MDS

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Trial Information

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


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®.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety and tolerability of revlimid and azacitidine combination

Outcome Description:

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

Outcome Time Frame:

2 -3 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MDS 2008-01

NCT ID:

NCT01379274

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Low and Intermediate 1 Risk MDS
  • MDS
  • Low risk disease
  • IPSS
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824