Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia

PRIMARY OBJECTIVES:

I. To determine feasibility of a randomized controlled trial comparing two different platelet
transfusion thresholds (50 x 10^9/L versus [vs] 30 x 10^9/L) in patients with treatment or
malignancy-induced thrombocytopenia requiring therapeutic anticoagulation.

SECONDARY OBJECTIVES:

I. Progressive or new venous thromboembolic (VTE).

II. Progressive or new arterial thromboembolism (ATE).

III. Hemorrhagic events (World Health Organization [WHO] grade 2 or greater).

IV. A composite of I, II and III.

V. Major bleeds (WHO grade 3 or 4).

VI. Number of platelet transfusions per patient during the study period.

VII. Platelet transfusion related complications (including transfusion reactions,
alloimmunization and volume overload).

VIII. Degree to which platelet target thresholds are achieved.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I (Lower dose): Patients undergo platelet transfusion on all days when the morning
platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet
count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of
transfusions.

GROUP II (Higher dose): Patients undergo platelet transfusion on all days when the morning
platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet
count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of
transfusions.

After completion of study, patients are followed up at 30 days.

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