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Phase II Study of Lenalidomide in Patients With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome Associated With Chromosome 5 Abnormalities

Phase 2
18 Years
Not Enrolling
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Thank you

Trial Information

Phase II Study of Lenalidomide in Patients With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome Associated With Chromosome 5 Abnormalities

Revlimid is designed to change the body's immune system. It may also interfere with the
development of tiny blood vessels that help support tumor growth. It is possible that it
may help reduce or prevent the growth of cancer cells.

You will have a bone marrow aspiration performed before starting treatment (within 4 weeks)
on this study and at about 12 weeks after starting treatment on this study. Your doctor may
also decide to perform a bone marrow aspiration before 12 weeks to assess your response to
treatment. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed
with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

If you are found to be eligible to take part in this study, you will take Revlimid once a
day by mouth (with a full glass of water, at least 1 hour before or after a meal) for 21

You will then have 7 days off of the study drug, which is considered a rest period. This
entire period is considered 1 cycle of therapy (28 days). The number of treatment cycles
you may have will depend on the response of your disease to treatment on this study. You
will have blood drawn (about 3 tablespoons) to test for blood counts and chemistries before
each treatment cycle. At the end of 3 cycles, your disease will be evaluated for response
to the study treatment.

You will be required to return to M. D. Anderson once a month for the first 3 months on this
study or as often as the study doctor thinks it is best.

After the first 3 months on this study, you may have blood drawn (about 3 tablespoons) for
blood counts and chemistries at your regular doctor's office. The results of your blood
tests will then be sent to the research nurse. Your side effects will be reviewed by a
doctor or nurse by telephone (in addition to being reviewed in your study diary) before the
start of each cycle of treatment. This phone call will last about 10 minutes each time.

You will be taken off this study if your disease gets worse or you experience any
intolerable side effects. It is also possible that the study doctor may decide to take you
off this study if your disease response is considered less than a complete response. You
will have an end-of-study visit, if you are taken off this study for any reason. During the
end-of-study visit, you will have blood drawn (about 3 tablespoons) for blood counts and
chemistries. You will have an ECG. You may have a urine pregnancy test. You will also
have a bone marrow aspiration performed.

This is an investigational study. Revlimid® (lenalidomide) is indicated for the treatment
of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk
myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities. Revlimid® is also approved in combination
with dexamethasone for the treatment of patients with multiple myeloma that have received at
least one prior therapy. In this case it will be considered investigational. Up to 30
patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age >/= 18 years at the time of signing the informed consent form. (Revlimid has not
been tested in younger patients)

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Diagnosis of relapsed/refractory AML (other than APL) or high-risk MDS (IPSS
categories intermediate-2 and high) with chromosome 5 abnormality as a sole
abnormality or with additional abnormalities. MDS patients with blast percentage of
>/= 10% will be considered high-risk.

5. All non-hematological toxicity of previous cancer therapy should have resolved to grade1 (except alopecia or other toxicities not involving major organs).

6. Should not have received any prior treatment for AML or MDS within 2 weeks of
starting Revlimid. Use of hydrea to control proliferative disease will be allowed
prior to starting Revlimid and for 7 days during cycles 1 and 2 (Maximum daily dose
of 7gm).

7. Eastern Cooperative Oncology Group (ECOG) performance status of
8. Laboratory test results within these ranges: • Serum creatinine bilirubin aminotransferase (ALT or SGPT) related to disease

9. Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL
within 10 - 14 days prior to and again within 24 hours of prescribing Revlimid
(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 4 weeks before she starts taking Revlimid. FCBP must also agree to
ongoing pregnancy testing.

10. (continued from above) Men must agree to use a latex condom during sexual contact
with a FCBP even if they have had a successful vasectomy.

11. All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®.

12. Disease free of prior malignancies for >/ = 2 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the
cervix or breast.

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).

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 experimental therapy within 28 days of

5. Known hypersensitivity to thalidomide.

6. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

7. Any prior use of Revlimid.

8. Concurrent use of other anti-cancer agents or treatments. (Use of hydrea permitted as
indicated in inclusion criterion 6)

9. Known positive for HIV or infectious hepatitis type B or C.

10. Heart rate less than or equal to 50.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rates (complete remissions (CR), complete remissions with incomplete platelet recovery [CRp] and partial responses)

Outcome Description:

Response for AML according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for MDS was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, PR, marrow CR, and hematological improvement considered responders.

Outcome Time Frame:

Following three 28-day cycles evaluated for response

Safety Issue:


Principal Investigator

Gautam Borthakur, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

May 2012

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



UT MD Anderson Cancer Center Houston, Texas  77030