A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Centocor, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00656448

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.

Condition	Intervention	Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome Leukemia	Drug: Procrit	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of transfusions (trn) required during the 12 weeks of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete Remission Rate [ Time Frame: February 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Procrit	Drug: Procrit 40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
2: No Intervention No intervention

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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656448

Contacts

Contact: Gloria N Mattiuzzi, M.D.	713-745-2723	gmattiuz@mdanderson.org
Contact: Jorge E. Cortes, M.D.	713-794-5783	jcortes@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Jorge E. Cortes, M.D. 713-794-5783 jcortes@mdanderson.org
Principal Investigator: Jorge E. Cortes, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Centocor, Inc.

Investigators

Study Chair:

Jorge E. Cortes, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Jorge Cortes M.D./Professor )
Study ID Numbers:	2005-0890
Study First Received:	April 7, 2008
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00656448 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Myelogenous Leukemia
AML
Myelodysplastic Syndrome
MDS

Leukemia
Procrit
Epoetin Alfa
Epogen

Additional relevant MeSH terms:

Epoetin Alfa
Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematinics
Hematologic Diseases
Hematologic Agents
Myelodysplastic Syndromes
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 08, 2010