This trial is active, not recruiting.

Conditions acute lymphoblastic leukemia, acute lymphocytic leukemia (all), acute myelogenous leukemia (aml), acute promyelocytic leukemia (apl)
Treatments rbc transfusion: restrictive threshold (7 g/dl hb), rbc transfusion: standard threshold (8 g/dl hb)
Phase phase 0
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date April 2014
End date April 2017
Trial size 90 participants
Trial identifier NCT02086773, J13126, NA_00089706


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Patients receive blood transfusion with transfusion threshold of 7g/dL Hb
rbc transfusion: restrictive threshold (7 g/dl hb)
RBC transfusion with transfusion threshold of 7g/dL Hb.
(Active Comparator)
Patients receive blood transfusion with transfusion threshold of 8g/dL Hb
rbc transfusion: standard threshold (8 g/dl hb)
RBC transfusion with transfusion threshold of 8g/dL Hb

Primary Outcomes

The safety of a restrictive transfusion threshold of 7g/dL compared to subjects with the current standard transfusion threshold of 8g/dL
time frame: 60 days

Secondary Outcomes

The feasibility of doing a large randomized trial comparing these transfusion strategies
time frame: 60 days
The number of red cells and platelets transfused per patient
time frame: 60 days
The number of patients with neutropenic infections
time frame: 60 days
The number of Grade 3 and 4 bleedings
time frame: 60 days
The length of inpatient stay
time frame: 60 days
Treatment related mortality
time frame: 60 days
End organ dysfunction
time frame: 60 days
Number of patients with Eastern Cooperative Oncology Group (ECOG) performance status <2
time frame: 60 days
The incidence of treatment cross-over due to symptomatic anemia
time frame: 60 days
Cost savings of the transfusion with a reduced transfusion threshold
time frame: 60 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Acute leukemia patients (AML, ALL, APL, high grade MDS) - Admitted with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens) Exclusion Criteria: - Age less than 18 years - Acute coronary syndrome as defined by active chest pain, dynamic ECG changes, troponin greater than 2.5 - Active blood loss - Receiving erythropoietin stimulating agents prior to admission - Chronic Renal Failure in Renal Replacement Therapy - Documented wish against transfusion for personal or religious beliefs

Additional Information

Official title Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
Principal investigator Amy DeZern, MD, MHS
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.