Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
Condition: Acute Biphenotypic Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; B-Cell Non-Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematologic and Lymphocytic Disorder; Hematopoietic Cell Transplantation Recipient; Myelodysplastic Syndrome; Primary Myelofibrosis; Secondary Myelofibrosis; T-Cell Non-Hodgkin Lymphoma; Thrombocytopenia; Venous Thromboembolism
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, B-Cell; Lymphoma, T-Cell; Leukemia, Biphenotypic, Acute; Thromboembolism; Venous Thromboembolism; Myelodysplastic Syndromes; Thrombocytopenia; Primary Myelofibrosis; Hematologic Diseases
Intervention: Platelet Transfusion; Platelet Transfusion
Intervention description: Undergo lower dose platelet transfusion; Undergo higher dose platelet transfusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial compares the safety of two different platelet transfusion
      "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose
      condition requires anticoagulant medication (blood thinners) for blood clots. Giving
      relatively fewer platelet transfusions may reduce the side effects of frequent platelet
      transfusions without leading to undue bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid
             leukemia [AML], acute lymphoblastic leukemia [ALL], biphenotypic leukemia) undergoing
             curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem
             cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as
             above, chronic myelogenous leukemia [CML], chronic lymphocytic leukemia [CLL],
             myelodysplastic syndrome [MDS], primary or secondary myelofibrosis, hypereosinophilic
             syndromes, plasma cell disorders, B-cell or T-cell lymphoma)

          -  Disease may be measurable or non-measurable

          -  Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose
             anticoagulation (unfractionated or low-molecular weight heparin or oral
             anticoagulants) throughout the period of hematopoietic recovery

          -  Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Separate episode of VTE or arterial thrombosis within 3 months of enrollment

          -  Major bleed (WHO grade 3 or 4) within 6 months of enrollment

          -  Active bleeding (grade 2 or higher) at the time of enrollment

          -  History of intracranial bleeding at any time

          -  Disorders of hemostasis including von Willebrand disease, hemophilia, platelet
             function disorders

          -  Concomitant use of aspirin or non-steroidal anti-inflammatory drugs

          -  Evidence of disseminated intravascular anticoagulation (DIC) as determined by the
             patient's primary provider

          -  History of alloimmunization (defined as platelet refractoriness with panel reactive
             antibody [PRA] > 25%) at the time of or prior to enrollment

          -  Uncontrolled or concurrent illness including, but not limited to, ongoing or active
             infection, unstable angina pectoris

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Pregnant or able to become pregnant and unwilling to use two forms of birth control
             during the study period