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Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)


The Study Drugs:

Azacitidine is designed to block certain proteins that stop the function of tumor-fighting
genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

Lenalidomide is designed to change the immune system. It may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may decrease or prevent the growth of cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you joined this study. Up to 6 groups of 3-6 participants will be
enrolled in the Phase 1 portion of the study, and up to 40 participants will be enrolled in
Phase 2.

If you are enrolled in the Phase 1 portion, the dose of lenalidomide you receive will depend
on when you joined this study. The first group of participants will receive the lowest dose
level of lenalidomide. Each new group will receive a higher dose of lenalidomide than the
group before it, if no intolerable side effects were seen. This will continue until the
highest tolerable dose of lenalidomide is found.

If you are enrolled in the Phase 2 portion, you will receive lenalidomide at the highest
dose that was tolerated in the Phase 1 portion.

All participants will receive the same dose level of azacitidine.

Study Drug Administration:

Each study "cycle" will be about 3-8 weeks, depending on how well you tolerate the drugs,
any side effects that you may have, and how your blood count and bone marrow recovers.

On Days 1-5 of every cycle, you will receive azacitidine by vein over 15-30 minutes.

If you are enrolled in Phase 2 of the study, on Days 6-15 of every cycle, you will take
capsules of lenalidomide by mouth.

You should swallow lenalidomide capsules whole with a cup (about 8 ounces) of water at the
same time each day. Do not break, chew, or open the capsules. If you miss a dose of
lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose
for the entire day, take your regular dose the next scheduled day (do NOT take double your
regular dose to make up for the missed dose). If you take more than the prescribed dose of
lenalidomide, you should seek emergency medical care if needed and contact study staff right
away. Any unused lenalidomide should be returned as instructed through the RevAssist®
program.

Any woman who can become pregnant should wear gloves if touching the lenalidomide capsules.

Your dose of study drugs may be lowered if you experience side effects.

You may be given drugs to help prevent side effects, such as nausea, vomiting, and/or
diarrhea. The doctor will tell you more about what drugs you may receive.

Study Visits:

At every study visit, you will be asked about any other drugs and/or treatments you may be
receiving and about any side effects you may be having.

One (1) time during each week of Cycle 1:

- Your medical history will be recorded.

- You will have a physical exam.

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

On Days 21 and 28 of Cycle 1 (+/- 3 days), you will have a bone marrow aspiration performed
to check the status of the disease. You will then have a bone marrow aspiration performed
every 7-14 days for the rest of the study. If at any point the disease appears to go into
remission, you will then have a bone marrow aspiration performed every 1-3 cycles.

Before Day 1 of Cycles 2 and beyond:

- Your medical history will be recorded.

- You will have a physical exam.

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

Pregnancy Testing:

If you are a woman who is able to become pregnant, you will have blood (about 1-2
tablespoons) or urine pregnancy tests 1 time a week for the first 4 weeks of the study, then
every 4 weeks while on study, when you stop the study, and 4 weeks after you are off study.

If you are a woman who is able to become pregnant and your menstrual cycles are irregular,
you will have blood (about 1-2 tablespoons) or urine pregnancy test 1 time a week for the
first 4 weeks, then every 2 weeks while on study, when you stop the study, and 2 and 4 weeks
after you are off study.

Length of Study:

You may receive azacitidine for up to 12 cycles (about 12-18 months). You may receive
lenalidomide as part of this study for as long as you are benefitting. You will be taken off
study if the disease gets worse or you experience intolerable side effects.

This is an investigational study. Both azacitidine and lenalidomide are FDA approved and
commercially available for the treatment of MDS. Azacitidine is not FDA approved or
commercially available for treatment of AML. The combination as used in this study is
investigational.

Up to 88 participants will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any
age who refuse or are not eligible for frontline chemotherapy.

2. No prior therapy for higher risk MDS as defined above.

3. Performance status of
4. Signed informed consent indicating that patients are aware of the investigational
nature of this study in keeping with the policies of UTMDACC.

5. Hydroxyurea for patients with rapidly proliferative disease can be used up to 24
hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide.
Hydroxyurea can be used once the patient has completed the planned 5 azacitidine and
lenalidomide treatment.

6. Adequate liver function (bilirubin of related to leukemia tissue infiltration)

7. Renal function - creatinine
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
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of prescribing lenalidomide (prescriptions must be filled
within 7 days) 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. FCBP must also agree to ongoing pregnancy testing.

10. Continued from #9: Men must agree to use a latex condom during sexual contact with a
FCBP even if they have had a successful vasectomy.

Exclusion Criteria:

1. Nursing and pregnant females.

2. Known or suspected hypersensitivity to azacitidine or mannitol.

3. Patients with advanced malignant hepatic tumors.

4. Unwilling or unable to remain in compliance with the RevAssist® program.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Dose Tolerated (MTD)

Outcome Time Frame:

3-8 week cycles

Safety Issue:

Yes

Principal Investigator

Guillermo Garcia-Manero, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0467

NCT ID:

NCT01038635

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Leukemia
  • 5-Azacytidine
  • 5-Aza
  • Lenalidomide
  • Revlimid
  • CC-5103
  • Myelodysplastic Syndrome
  • MDS
  • Acute Myelogenous Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030