Acute Myeloid Leukemia, B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Myeloid Neoplasm
Conditions
Brief summary
This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and/or anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the "minimum" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\> 7 gm/dL) compared to a more liberal hemoglobin threshold (\> 9 gm/dL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 gm/dL or less, starting the day after standard of care (SOC) chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study. ARM II: Patients undergo PRBC transfusion if at any point their hemoglobin level is 9 gm/dL or less, starting the day after SOC chemotherapy/stem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study. After completion of study intervention, patients are followed up for 7 days and then periodically for up to 5 years.
Interventions
OTHERActivity Tracking
Ancillary studies
PROCEDUREBiospecimen Collection
Undergo blood sample collection
PROCEDURECognitive Assessment
Ancillary studies
OTHERElectronic Health Record Review
Ancillary studies
Undergo PRBC transfusion
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of "high-grade" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia \[APL\]) or B-cell acute lymphoblastic lymphoma/leukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis * Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as "7+3," hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone \[CVAD\], or regimen with cytarabine backbone ≥ 1,000mg/m\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000/uL for ≥ 5 days following the therapy (as determined by principal investigator) * Plan to get all post-chemotherapy/post-HSCT care at the University of Washington (UW)/Fred Hutchinson Cancer Center (FHCC) * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients requiring a prophylactic platelet transfusion at thresholds \> 10,000/uL * Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \< 50,000/uL * Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization * Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy/HSCT * Patients requiring renal replacement therapy at the time of randomization * Patients who decline transfusion for personal or religious beliefs * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of eligible patients that consent (feasibility) | Up to 30 months | Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 50% of eligible patients consent. |
| Percentage of patients randomized to the restrictive 7 gm/dL threshold that tolerate this transfusion trigger (feasibility) | Up to 7 days after completion of study intervention | Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 75% of the patients randomized to the restrictive 7 gm/dL threshold tolerate this transfusion trigger. A patient will be defined as tolerant if the patient receives transfusions at a hemoglobin threshold higher than \> 7gm/dL less than 3 times due to signs/symptoms of acute anemia. |
| Indication for early termination based on interim analyses of safety (feasibility) | Up to 30 months | Randomizing patients to two different transfusion thresholds will be considered feasible if there is no indication for early termination based on the interim safety analyses. |
Countries
United States
Contacts
CONTACTAnna Halpern, MD
PRINCIPAL_INVESTIGATORAnna Halpern, MD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed