Advertisement

Topics

Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

2014-08-27 03:14:45 | BioPortfolio

Summary

The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer who have received treatment with epoetin alfa.

Description

Epoetin alfa is a medication that helps the body make more red blood cells.

Before treatment you will have a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of your standard of care). Women who are able to have children must have a negative blood pregnancy test.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Patients in the first group will be given epoetin alfa once a week at the time chemotherapy is started. Patients in the other group will not receive epoetin alfa, but will undergo the same laboratory exams and quality of life evaluations as the group of patients who were given epoetin alfa.

Patients in both groups will receive transfusions if their hemoglobin drops below a certain level or it the doctor feels it is necessary. These transfusions are considered to be standard of care. You will be asked to keep a diary listing the dates of all transfusions you receive.

If you are assigned to receive epoetin alfa, you will be given epoetin alfa once a week during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa for up to 6 courses of chemotherapy (usually around 5 months, but may be longer). Epoetin alfa will be given to you as an injection under the skin. Once a week, you will have around 1 tablespoon of blood drawn to check the level of hemoglobin in your blood. If your hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.

Patients in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of your standard of care for treatment of cancer).

If you agree to the optional procedures, you will continue receiving epoetin alfa even if your hemoglobin levels show that you are not responding to epoetin alfa treatment. However, if you do not choose to take part in the optional procedures and you are not responding to epoetin alfa treatment, you will be taken off the study.

If you experience any intolerable side effects that are a result of epoetin alfa or your disease gets worse, you will be taken off the study.

This is an investigational study. Epoetin alfa is FDA approved and commercially available. Around 164 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

Procrit (epoetin alfa)

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Active, not recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:45-0400

Clinical Trials [2186 Associated Clinical Trials listed on BioPortfolio]

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

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 recei...

A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks...

The Duration Study

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in pati...

Pharmacokinetic/ Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Critically Ill Patients.

The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing regimens of epoetin alfa (PROCRIT®) in anemic critically ill subjects

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with an...

PubMed Articles [1130 Associated PubMed Articles listed on BioPortfolio]

Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis.

For patients with anemia undergoing hemodialysis, erythropoiesis-stimulating agents (ESAs) are typically dosed via precise algorithms. Using one such algorithm, we assessed the maintenance of hemoglob...

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.

Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III ...

Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study.

Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007.

Epoetin alfa resistance in hemodialysis patients with chronic kidney disease: a longitudinal study.

Anemia is an inevitable complication of hemodialysis, and the primary cause is erythropoietin deficiency. After diagnosis, treatment begins with an erythropoiesis-stimulating agent (ESA). However, som...

Preoperative Epoetin-α with Intravenous or Oral Iron for Major Orthopedic Surgery: A Randomized Controlled Trial.

WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Preoperative administration of epoetin-α with iron is commonly used in anemic patients undergoing major orthopedic surgery, but the optimal route ...

Medical and Biotech [MESH] Definitions

This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.

More From BioPortfolio on "Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...


Searches Linking to this Trial