An interventional study of Procrit (epoetin alfa) in Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 109 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Starting dose 40,000 units subcutaneously once a week with chemotherapy.
Drug: Procrit (epoetin alfa)
No intervention.
Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).
Also known as: epoetin alfa, Epogen, Erythropoietin
Mean Number of RBC Units Transfused During Initial 5 Months of Treatment
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.
Time frame: 5 weeks to 5 Months
Number of PRBC Transfusions During Initial 5 Months of Treatment
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.
Time frame: 5 weeks to 5 Months
Recruitment Period 3/11/2003 - 5/25/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.
| Milestone | Procrit | No Procrit |
|---|---|---|
| Started | 55 | 54 |
| Completed | 55 | 54 |
| Not completed | 0 | 0 |
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.
| PRBC Units | Procrit | No Procrit |
|---|---|---|
| Mean Number of RBC Units Transfused During Initial 5 Months of Treatment | 10.63 ± 6.29 | 13.11 ± 5.18 |
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.
| transfusions | Procrit | No Procrit |
|---|---|---|
| Number of PRBC Transfusions During Initial 5 Months of Treatment | 6.22 ± 3.87 | 7.44 ± 3.28 |
Collected over 8 years, 2 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Procrit | — | 8/55 (14.5%) | 0/55 (0%) |
| No Procrit | — | 6/54 (11.1%) | 0/54 (0%) |
| Event | Procrit | No Procrit |
|---|---|---|
| InfectionInfections and infestations | 5/55 | 2/54 |
| Deep Vein ThrombosisCardiac disorders | 3/55 | 2/54 |
| SeizuresNervous system disorders | 1/55 | 2/54 |
| DeathGeneral disorders | 0/55 | 1/54 |
| Pulmonary EmbolismCardiac disorders | 1/55 | 0/54 |
| StrokeCardiac disorders | 1/55 | 0/54 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/55 | 0/54 |
| Age Continuous(years) | Procrit | No Procrit | Total |
|---|---|---|---|
| Median | 39 (18 to 76) | 42 (15 to 84) | 41 (15 to 84) |
| Sex: Female, Male(Participants) | Procrit | No Procrit | Total |
|---|---|---|---|
| Female | 22 | 30 | 52 |
| Male | 33 | 24 | 57 |
| Region of Enrollment(participants) | Procrit | No Procrit | Total |
|---|---|---|---|
| United States | 55 | 54 | 109 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center