Omacetaxine in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (HMA) Failure
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/28/2018 |
Start Date: | May 18, 2015 |
End Date: | May 2019 |
A Phase II Study of Omacetaxine (OM) in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (HMA) Failure
The goal of this clinical research study is learn if omacetaxine can help to control
myelodysplastic syndrome (MDS). The safety of this drug will also be studied.
This is an investigational study. Omacetaxine is FDA approved and commercially available for
the treatment of chronic myelogenous leukemia (CML). It is investigational to use omacetaxine
in patients with MDS. The study doctor can explain how the study drug is designed to work.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
myelodysplastic syndrome (MDS). The safety of this drug will also be studied.
This is an investigational study. Omacetaxine is FDA approved and commercially available for
the treatment of chronic myelogenous leukemia (CML). It is investigational to use omacetaxine
in patients with MDS. The study doctor can explain how the study drug is designed to work.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Study Drug Administration:
Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drug.
If you are found to be eligible to take part in this study, you will receive omacetaxine as
an injection under your skin 2 times each day, about 12 hours apart, on Days 1-3 of every
28-day study cycle.
You will receive instructions on how to give these injections to yourself. You will be given
a Research Drug Diary to record the drug you take each day. You must bring the Research Drug
Diary and any unused drug with you to each study visit. You will also be told how to properly
store the drugs.
Depending on how the disease responds to the study drugs, the number of days you receive your
injections may stay the same, increase, or decrease. Your doctor will discuss this with you.
During Cycle 1, if the doctor thinks it is needed, you will be given hydroxyurea by mouth to
decrease the risk of side effects. You may ask the study staff for information about how the
drug is given and its risks.
Study Visits:
At the beginning of every cycle, you will have a physical exam before your dose of study
drug.
Every week (+/- 2 days), blood (about 2-3 teaspoons) will be drawn for routine tests. If the
disease appears to get better, this blood will only be drawn every 2-4 weeks while you are
still receiving the study drugs.
If you live far from the clinic, this blood can be drawn at a clinic close to your home, and
the results will be reported to the study doctor.
If the study doctor thinks it is needed, you may have an additional bone marrow aspirate at
any time during the study to check the status of the disease and for cytogenetic testing.
Length of Study:
You may continue taking the study drug for up to 24 cycles of treatment. You will no longer
be able to take the study drug if the disease gets worse, if intolerable side effects occur,
or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up:
You will have follow-up visits at the clinic every 3-6 months for up to 5 years after you
stop taking the study drug. You will be asked about your health and any new drugs you may be
taking. If you cannot come to the clinic, you will be called by the study staff and asked
about your health. These calls should last about 5-10 minutes.
Every 4-8 weeks after your last dose of study drug, blood (about 2-3 teaspoons) will be drawn
for routine tests.
Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drug.
If you are found to be eligible to take part in this study, you will receive omacetaxine as
an injection under your skin 2 times each day, about 12 hours apart, on Days 1-3 of every
28-day study cycle.
You will receive instructions on how to give these injections to yourself. You will be given
a Research Drug Diary to record the drug you take each day. You must bring the Research Drug
Diary and any unused drug with you to each study visit. You will also be told how to properly
store the drugs.
Depending on how the disease responds to the study drugs, the number of days you receive your
injections may stay the same, increase, or decrease. Your doctor will discuss this with you.
During Cycle 1, if the doctor thinks it is needed, you will be given hydroxyurea by mouth to
decrease the risk of side effects. You may ask the study staff for information about how the
drug is given and its risks.
Study Visits:
At the beginning of every cycle, you will have a physical exam before your dose of study
drug.
Every week (+/- 2 days), blood (about 2-3 teaspoons) will be drawn for routine tests. If the
disease appears to get better, this blood will only be drawn every 2-4 weeks while you are
still receiving the study drugs.
If you live far from the clinic, this blood can be drawn at a clinic close to your home, and
the results will be reported to the study doctor.
If the study doctor thinks it is needed, you may have an additional bone marrow aspirate at
any time during the study to check the status of the disease and for cytogenetic testing.
Length of Study:
You may continue taking the study drug for up to 24 cycles of treatment. You will no longer
be able to take the study drug if the disease gets worse, if intolerable side effects occur,
or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up:
You will have follow-up visits at the clinic every 3-6 months for up to 5 years after you
stop taking the study drug. You will be asked about your health and any new drugs you may be
taking. If you cannot come to the clinic, you will be called by the study staff and asked
about your health. These calls should last about 5-10 minutes.
Every 4-8 weeks after your last dose of study drug, blood (about 2-3 teaspoons) will be drawn
for routine tests.
Inclusion Criteria:
1. Age >/= 18 years
2. Diagnosis of MDS confirmed within 10 weeks prior to study entry according to WHO
criteria. Patients are either not eligible for or choose not to proceed with a stem
cell transplant.
3. MDS classified as follows: RAEB-1 (5%-9% BM blasts); RAEB-2 (10%-19% BM Blasts); CMML
(5%-19% BM blasts); RAEB-t (20%-29% BM blasts) AND/OR by IPSS: intermediate-1 and high
risk patients.
4. No response, progression, or relapse (according to 2006 IWG criteria) following at
least 4 cycles of either azacitidine or decitabine, which were completed within the
last 2 years - AND/OR - intolerance to azacitidine or decitabine defined as
drug-related >/= grade 3 hepatic or renal toxicity leading to treatment
discontinuation during the preceding 2 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status of
6. Willing to adhere to and comply with all prohibitions and restrictions specified in
the protocol.
7. Patient (or patient's legally authorized representative) must have signed an informed
consent document indicating that the patient understands the purpose of and procedures
required for the study and is willing to participate in the study.)
Exclusion Criteria:
1. Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
2. Active infection not adequately responding to appropriate antibiotics (i.e. ongoing
temperatures of >/= 38 degree Celsius).
3. Total bilirubin >/= 1.5 mg/dL and not related to hemolysis or Gilbert's disease.
Patients with total bilirubin >/= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of
the bilirubin is indirect.
4. Alanine transaminase (ALT/SGPT) or aspartate transaminase (AST/SGOT) >/= 2.5 x the
upper limit of normal.
5. Serum creatinine > 1.5 mg/dL.
6. Female patients who are pregnant or lactating.
7. Patients with reproductive potential who are unwilling to following contraception
requirements (including condom use for males with sexual partners, and for females:
prescription oral contraceptives [birth control pills], contraceptive injections,
intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with
condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the
study.
8. Female patients with reproductive potential who do not have a negative urine or blood
beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
9. Patients receiving any other concurrent investigational agent or chemotherapy,
radiotherapy, or immunotherapy.
10. Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors
(eg, G-CSF, GM-CSF, procrit, aranesp, thrombopoietins) is allowed at any time prior to
or during study if considered to be in the best interest of the patient.
11. Psychiatric illness or social situation that would limit the patient's ability to
comply with study requirements.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
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