Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy
N/A
N/A
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia
Trial Information
Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy
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.
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 MD Anderson.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of transfusions (trn) required during the 12 weeks of treatment.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Jorge E. Cortes, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0890
NCT ID:
NCT00656448
Start Date:
March 2008
Completion Date:
June 2013
Related Keywords:
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- Leukemia
- Acute Myelogenous Leukemia
- AML
- Myelodysplastic Syndrome
- MDS
- Leukemia
- Procrit
- Epoetin Alfa
- Epogen
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| The University of Texas M.D. Anderson Cancer Center | Houston, Texas |
