Leukemia
Conditions
Keywords
Procrit, Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, Burkitt's, Chemotherapy, Hyper-CVAD, augmented BFM, Epoetin alfa, Epogen, Erythropoietin
Brief 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.
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.
Interventions
Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of RBC Units Transfused During Initial 5 Months of Treatment | 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. |
| Number of PRBC Transfusions During Initial 5 Months of Treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period 3/11/2003 - 5/25/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.
Participants by arm
| Arm | Count |
|---|---|
| Procrit Starting dose 40,000 Units subcutaneously once a week with chemotherapy. | 55 |
| No Procrit No intervention. | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Procrit | No Procrit | Total |
|---|---|---|---|
| Age Continuous | 39 years | 42 years | 41 years |
| Region of Enrollment United States | 55 participants | 54 participants | 109 participants |
| Sex: Female, Male Female | 22 Participants | 30 Participants | 52 Participants |
| Sex: Female, Male Male | 33 Participants | 24 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 8 / 55 | 6 / 54 |
Outcome results
Primary
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
Population: Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procrit | Mean Number of RBC Units Transfused During Initial 5 Months of Treatment | 10.63 PRBC Units | Standard Deviation 6.29 |
| No Procrit | Mean Number of RBC Units Transfused During Initial 5 Months of Treatment | 13.11 PRBC Units | Standard Deviation 5.18 |
Primary
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
Population: Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procrit | Number of PRBC Transfusions During Initial 5 Months of Treatment | 6.22 transfusions | Standard Deviation 3.87 |
| No Procrit | Number of PRBC Transfusions During Initial 5 Months of Treatment | 7.44 transfusions | Standard Deviation 3.28 |