Clinical trial NCT00656448: A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Leukemia
Keywords: Acute Myelogenous Leukemia
AML
Myelodysplastic Syndrome
MDS
Leukemia
Procrit
Epoetin Alfa
Epogen
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2008-04-11
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (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.

Detailed description: 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 the University of Texas (UT) MD Anderson Cancer Center.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (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 French-American-British (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.

Primary outcomes:
measure: Median Number of Participant Transfusions Required During 12 Weeks of Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With Complete Remission
timeFrame: After 1 course of therapy, one course is 4 weeks.
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jorge E. Cortes, M.D.
role: STUDY_CHAIR
References: