[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06710418":3,"trial-entities:NCT06710418":124,"trial-summary:NCT06710418":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":64,"secondary_outcomes":76,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":97,"locations":100,"central_contacts":118,"overall_officials":120,"references":122,"see_also_links":123},"NCT06710418","RG1124891","Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma\u002FLeukemia","Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study","RECRUITING","2027-12-31","2026-08","2026-08-19","2025-10-15","University of Washington","OTHER",true,"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\u002Fleukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and\u002For 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\u002FdL) compared to a more liberal hemoglobin threshold (\\> 9 gm\u002FdL) 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.","OUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo PRBC transfusion if at any point their hemoglobin level is 7 gm\u002FdL or less, starting the day after standard of care (SOC) chemotherapy\u002Fstem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study.\n\nARM II: Patients undergo PRBC transfusion if at any point their hemoglobin level is 9 gm\u002FdL or less, starting the day after SOC chemotherapy\u002Fstem cell infusion is complete and continuing for up to 42 days. Patients also undergo collection of blood samples on study.\n\nAfter completion of study intervention, patients are followed up for 7 days and then periodically for up to 5 years.",[19,20,21,22],"Acute Myeloid Leukemia","B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Myeloid Neoplasm",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},50,"ESTIMATED",[32,38,47,50,53,59],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Activity Tracking","Ancillary studies",[36,37],"Arm I (restrictive threshold)","Arm II (liberal threshold)",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[36,37],[44,45,46],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":39,"name":48,"description":34,"armGroupLabels":49},"Cognitive Assessment",[36,37],{"type":14,"name":51,"description":34,"armGroupLabels":52},"Electronic Health Record Review",[36,37],{"type":14,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Packed Red Blood Cell Transfusion","Undergo PRBC transfusion",[36,37],[58],"PRBC Transfusion",{"type":14,"name":60,"description":34,"armGroupLabels":61,"otherNames":62},"Quality-of-Life Assessment",[36,37],[63],"Quality of Life Assessment",[65,69,73],{"measure":66,"description":67,"timeFrame":68},"Percentage of eligible patients that consent (feasibility)","Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 50% of eligible patients consent.","Up to 30 months",{"measure":70,"description":71,"timeFrame":72},"Percentage of patients randomized to the restrictive 7 gm\u002FdL threshold that tolerate this transfusion trigger (feasibility)","Randomizing patients to two different transfusion thresholds will be considered feasible if greater than 75% of the patients randomized to the restrictive 7 gm\u002FdL threshold tolerate this transfusion trigger. A patient will be defined as tolerant if the patient receives transfusions at a hemoglobin threshold higher than \\> 7gm\u002FdL less than 3 times due to signs\u002Fsymptoms of acute anemia.","Up to 7 days after completion of study intervention",{"measure":74,"description":75,"timeFrame":68},"Indication for early termination based on interim analyses of safety (feasibility)","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.",[],"ALL","18 Years",null,false,{"inclusion":82,"exclusion":88,"raw_text":96},[83,84,85,86,87],"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\u002Fleukemia (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\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)","Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)","Ability to understand and the willingness to sign a written informed consent document",[89,90,91,92,93,94,95],"Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL","Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL","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\u002FHSCT","Patients requiring renal replacement therapy at the time of randomization","Patients who decline transfusion for personal or religious beliefs","Pregnancy or lactation","Inclusion Criteria:\n\n* Age ≥ 18 years\n* 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\u002Fleukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis\n* 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\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)\n* Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL\n* Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL\n* Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization\n* Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy\u002FHSCT\n* Patients requiring renal replacement therapy at the time of randomization\n* Patients who decline transfusion for personal or religious beliefs\n* Pregnancy or lactation",[98,99],"ADULT","OLDER_ADULT",[101],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":115},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[108,113],{"name":109,"role":110,"phone":111,"email":112},"Anna Halpern, MD","CONTACT","206-606-1978","halpern2@uw.edu",{"name":109,"role":114},"PRINCIPAL_INVESTIGATOR",{"lat":116,"lon":117},47.60621,-122.33207,[119],{"name":109,"role":110,"phone":111,"email":112},[121],{"name":109,"affiliation":102,"role":114},[],[],{"nct_id":4,"conditions":125,"biomarkers":126},[19,20,21,22],[],{"nct_id":4,"found":15,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an interventional study where participants are randomly assigned to one of two groups. The study plans to enroll 50 participants.","completed","Evaluating Red Blood Cell Transfusions for Blood Cancers","This study is looking at how different levels of hemoglobin (a protein in red blood cells) affect the quality of life and daily activities of people with certain blood cancers, including acute myeloid leukemia (AML) or B acute lymphoblastic lymphoma\u002Fleukemia (B-ALL). After receiving chemotherapy or a stem cell transplant, some patients need transfusions of packed red blood cells (PRBC). This trial compares two different approaches to when PRBC transfusions are given: one where transfusions happen when hemoglobin is 7 gm\u002FdL or less, and another when it's 9 gm\u002FdL or less. The goal is to find the best balance between safety and effectiveness, especially given blood supply challenges. You may be able to join if you are 18 or older and have one of these specific blood cancers.","After the main study intervention, you will be followed for 7 days and then periodically for up to 5 years.",127,"You would undergo packed red blood cell transfusions based on your assigned group and have blood samples collected. Some participants may also have activity tracking, cognitive assessments, and electronic health record reviews.","Not stated in the trial record.",[],"v2"]