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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2018-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (lower dose platelet transfusion)

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 Type EXPERIMENTAL

Platelet Transfusion

Intervention Type BIOLOGICAL

Undergo lower dose platelet transfusion

Group II (higher dose platelet transfusion)

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.

Group Type EXPERIMENTAL

Platelet Transfusion

Intervention Type BIOLOGICAL

Undergo higher dose platelet transfusion

Interventions

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Platelet Transfusion

Undergo lower dose platelet transfusion

Intervention Type BIOLOGICAL

Platelet Transfusion

Undergo higher dose platelet transfusion

Intervention Type BIOLOGICAL

Other Intervention Names

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Blood Platelet Transfusion Blood Platelet Transfusion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No