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

July 24, 2012 updated by: M.D. Anderson Cancer Center

A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with a diagnosis of ALL, LL, or Burkitt's receiving induction chemotherapy with Hyper-CVAD, any variant of Hyper-CVAD or augmented BFM at MD Anderson Cancer Center.
  2. Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy.
  3. Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer.

Exclusion Criteria:

  1. Hemoglobin greater than or equal to 10 g/dL.
  2. Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months.
  3. Patients with known hypersensitivity to mammalian-cell derived products or to human albumin.
  4. Uncontrolled hypertension
  5. History of thrombotic vascular event.
  6. Pregnant or lactating women.
  7. Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procrit
Starting dose 40,000 units subcutaneously once a week with chemotherapy.
Drug: Procrit (epoetin alfa)
Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).
Other Names:
  • Epogen
  • epoetin alfa
  • Erythropoietin
No Intervention: No Procrit
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of RBC Units Transfused During Initial 5 Months of Treatment
Time Frame: 5 weeks to 5 Months
Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.
5 weeks to 5 Months
Number of PRBC Transfusions During Initial 5 Months of Treatment
Time Frame: 5 weeks to 5 Months
Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.
5 weeks to 5 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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