A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS - NCT00656448-77030 (Clinical Trial 213663)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy213663.aspx
|
** Please review additional "Nearby Studies" on right ----->
This is an archived study that is no longer available, if you
would like to find active studies please
search our studies.
|
|
 |
 |
|
| City: |
|
Houston |
|
State:
|
|
TX |
| Zip Code: |
|
77030 |
| Conditions: |
|
Acute Myelogenous Leukemia - Myelodysplastic Syndrome - Leukemia |
| Purpose: |
|
The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help
decrease the need for blood transfusions in patients who have AML or high-risk MDS and are
receiving chemotherapy. Researchers also want to learn about the remission rates (rates of
recovery) in patients with cancer who have received treatment with epoetin alfa. The safety
and effectiveness of this therapy will also be studied.
|
| Study summary: |
|
Epoetin alfa is a medication that helps the body make more red blood cells. Researchers want
to find out if it will be effective in reducing the need for blood transfusions in patients
who have AML or high-risk MDS and are receiving chemotherapy.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have a
complete physical exam, including measurement of your vital signs (blood pressure, heart
rate, temperature, and breathing rate). You will have about 1 tablespoon of blood drawn for
routine tests and other blood tests for anemia studies. Women who are able to have children
must have a negative blood pregnancy test, which will be done with the routine blood sample
mentioned above.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of 2 treatment groups. Participants in one group will be
given epoetin alfa along with blood transfusions, if the doctor thinks it is necessary.
Participants in the other group will not receive epoetin alfa. Instead they will only have
blood transfusions, which is the standard of care.
No matter what group you are in, you will receive transfusions if your hemoglobin (an
element of red blood cells that carries oxygen) drops below a certain level or if the doctor
thinks it is necessary. You will be asked to keep a diary listing the dates of all
transfusions you receive.
The study doctor will monitor your hemoglobin levels by checking your standard blood tests
done by your treating doctor. If your hemoglobin rises above a certain level, treatment
with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.
If you are assigned to receive epoetin alfa, you will receive it once a week by subcutaneous
(just under the skin) injection during your regularly scheduled chemotherapy. You will
receive treatment with epoetin alfa for up to 12 weeks.
If you experience any intolerable side effects or the disease gets worse, you will be taken
off this study.
Participants in both groups will continue to receive chemotherapy during this study as
regularly scheduled. During chemotherapy (as part of your standard of care), you will have
around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests.
This is an investigational study. Epoetin alfa is FDA approved and commercially available.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson. |
| Criteria: |
|
Inclusion Criteria:
- Patients with a diagnosis of AML or high-risk MDS (based on IPSS: refractory anemia
with excess of blasts [RAEB] or RAEB in transformation [RAEB-t]) receiving frontline
induction chemotherapy with any high dose or conventional dose cytarabine-containing
regimen or clofarabine-containing regimen at MD Anderson Cancer Center.
- Patients must be enrolled on the study within two weeks of the start of induction
chemotherapy.
- Patients with documented iron, vitamin B12, or folate deficiency are eligible, but
should receive replacement therapy while on study.
- Understand and voluntarily sign an informed consent form.
Exclusion Criteria:
- Patients with prior treatment with any form of erythropoietin within the previous
month.
- Patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically
significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis
within the last 5 years.
- New onset (within 3 months prior to randomization) or poorly controlled seizures.
- Patients with known hypersensitivity to the active substance or any of the
excipients.
- Pregnant or lactating women.
- Acute Erythroleukemia (M6 FAB classification)
- Hemoglobin greater than or equal to 10g/dl
- Patients with head and neck cancer receiving radiation therapy when
erythropoiesis-stimulating agents (ESAs) were given to maintain hemoglobin levels of
more than 12 g/dL.
- Patients with metastatic breast cancer receiving chemotherapy when ESAs were given to
maintain hemoglobin levels of more than 12 g/dL.
- Patients with chronic kidney failure when ESAs were given to maintain hemoglobin
levels of more than 12 g/dL.
- Patients requiring major surgery would be taken off study due to a higher chance of
blood clots being reported while taking ESAs. |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 4, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|