A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS

NCT00656448 | Completed Phase 3 Results DMC

• 1 other identifier: 2005-0890
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Leukemia

Keywords

Acute Myelogenous Leukemia; AML; Myelodysplastic Syndrome; MDS; Leukemia; Procrit; Epoetin Alfa; Epogen

Outcome Measures

Primary Outcomes (1)

• Median Number of Participant Transfusions Required During 12 Weeks of Treatment

  The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.

  12 weeks

Secondary Outcomes (1)

• Number of Participants With Complete Remission

  After 1 course of therapy, one course is 4 weeks.

Study Arms (2)

Procrit Arm

EXPERIMENTAL

Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.

Drug: Procrit

No Procrit: Standard Arm

NO INTERVENTION

Participants do not receive Procrit before receiving blood transfusions.

Interventions

Procrit DRUG

40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.

Also known as: Epoetin Alfa, Epogen

Procrit Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Centocor, Inc.: collaborator

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas MD Anderson Cancer Center's Official Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Jorge Cortes M.D./Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713/794-5783

Study Officials

• Jorge E. Cortes, M.D.

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 30, 2018
• Results First Posted: December 23, 2013

Record last verified: 2018-05

Locations

US (1)