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Epoetin Alfa

epoetin alfa

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week, double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life benefits associated with the use of epoetin alfa in patients receiving chemotherapy for selected cancers. During the double-blind period there will be two groups of patients: one group receiving epoetin injections under the skin 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group receiving injections under the skin of a placebo of matching appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of the study will be available to all patients completing the 12-week comparison period. The primary measure of effectiveness is determined by the proportion of patients with no transfusions after the first month. Additional measures of effectiveness include: the proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative transfusion rate and proportion of patients transfused during the double-blind phase (excluding the first month), as well as the mean change over the study period in scores for energy, activity and overall quality of life. The results will be analyzed separately for non-platinum-containing chemotherapy and for different tumor types. Safety evaluations include assessments of the incidence and severity of adverse events, clinical laboratory tests, vital sign measurements, and physical examinations. The hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia, reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.

The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy

A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Promyelocytic, Acute

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Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

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Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Patients receive red blood cell transfusions with a transfusion threshold of 7 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Patients receive red blood cell transfusions with a transfusion threshold of 8 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Red blood cell transfusion

Amy DeZern, MD, MHS

The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.

Transfusion of red blood cells (RBCs) is vitally important for the care of patients undergoing myelosuppressive therapy for acute leukemia. The therapeutic approach to this disease involves the use of high doses of chemotherapy to treat the blood cancers and bone marrow disorders; but it damages the marrow and blood system. Malignant and healthy stem cells are affected by the chemotherapy, and even when the malignant cells are killed, it can take weeks for the healthy cells to reconstitute the marrow. At diagnosis and before bone marrow recovery post treatment, RBCs are needed to support the patient. Current practices at major comprehensive cancer centers all utilize liberal hemoglobin transfusions triggers of 8-9 g/dL or higher. Higher hemoglobin levels in these high risk patients may have benefits such as better energy and organ function. However, research in a variety of clinical settings, suggests that a higher hemoglobin transfusion threshold is associated with the same or even higher mortality rates compared to lower hemoglobin thresholds (7-8 g/dL). These other settings include prospective randomized trials in high-risk orthopedic surgery patients, critically ill adult and pediatric ICU patients, acute GI bleed patients, and patients undergoing cardiac surgery. One clinical scenario where the ideal transfusion threshold is unknown is in patients receiving chemotherapy for hematologic malignancies. Transfusion requirements and triggers have not been systematically studied in acute leukemia or other cancers. Acute leukemia carries a high mortality; any unnecessary increase in morbidity or mortality is not acceptable. Without a clear benefit of higher transfusion thresholds, the added risks and costs of transfusion may be substantial and unnecessary. The investigators plan to study this issue in this pilot and feasibility study by randomly assigning patients treated for acute leukemia to be transfused with RBCs at either a higher or lower hemoglobin concentration trigger point. In this way, the investigators will be able to accurately determine if there is benefit or harms to having a lower or higher red cell count during the induction treatment and recovery period for patients with acute leukemias. This study will also collect information evaluating the advantages and disadvantages of the two transfusion thresholds and the feasibility of expanding the study to a large randomized trial.This safety data will serve as a platform for a larger mortality study in leukemia and possibly additional studies in solid tumors.

Red Cell Transfusion Goals in Patients With Acute Leukemias

Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias

Overall safety is determined by the total difference between arms for the number of transfusions given per participant

Overall safety is determined by the total difference between arms for number of participants experiencing neutropenic infections, where neutropenia is defined as absolute neutrophil count \< 500/mcL.

As per protocol-defined criteria, the transfusion strategy being tested would be deemed feasible if all of the following criteria are met: 1) More than 50% of eligible patients could be consented; 2) More than 75% of participants randomized to the low arm tolerated the 7 g/dL transfusion threshold; 3) Fewer than 15% of participants crossed over from the low arm to the high arm; 4) The study was not paused for safety concerns.

Median number of red cell and platelet transfusions given per participant.

Number of participants in each arm experiencing neutropenic infections, where neutropenia is defined as absolute neutrophil count \< 500/mcL.

Number of grade 3-4 bleeding events as defined by CTCAE 4.0.

Median length of inpatient stay in days. This is for the initial inpatient stay for induction chemotherapy only (chemotherapy itself was not part of this protocol).

Number of deaths attributed to induction chemotherapy.

Number of participants with at least one grade 3-5 nonhematological toxicity as defined by CTCAE 4.0.

Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status \< 2. The ECOG scale is rated from 0 to 5, where 0 is best health and 5 is dead.

Number of participants who crossed over from the low to the high arm due to symptomatic anemia (defined as Hb \< 8 g/dL with symptoms).

Estimated per-patient cost savings of the low transfusion threshold compared to the high transfusion threshold.

Median difference in fatigue scores as graded on the National Cancer Institute Fatigue Scale. Scores are from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy	NCT00270166	Anemia Multiple Myelom... Lymphoma Breast Cancer Ovarian Cancer Carcinoma, Smal... Esophagus Cance... Prostate Cancer Neoplasm	epoetin alfa	18 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Red Cell Transfusion Goals in Patients With Acute Leukemias	NCT02086773	Acute Lymphobla... Acute Lymphocyt... Acute Myelogeno... Acute Promyeloc...	Red blood cell ...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Red Cell Transfusion Goals in Patients With Acute Leukemias	NCT02086773	Acute Lymphobla... Acute Lymphocyt... Acute Myelogeno... Acute Promyeloc...	Red blood cell ...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for red cell transfusion