Clinical trial NCT03195010: Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
Official title: Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Eligible Patients Approached for the Study
timeFrame: Up to 1 year
measure: Number of Patients Approached for But Refusing Consent
timeFrame: Up to 1 year
measure: Number of Patients Consenting to Enrollment
timeFrame: Up to 1 year
measure: Number of Patients Eligible
timeFrame: Up to 1 year
measure: Number of Patients Screened and Deemed Ineligible
timeFrame: Up to 1 year
measure: Number of Patients Successfully Following Protocol
timeFrame: Up to 1 year
Secondary outcomes:
measure: Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)
timeFrame: Up to 1 year
measure: Major Bleeds (World Health Organization Grade 3 or 4)
timeFrame: Up to 1 year
measure: Number of Platelet Transfusions Per Patient During the Study Period
timeFrame: Up to 1 year
measure: Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)
timeFrame: Up to 1 year
measure: Platelet Transfusion Related Complications
timeFrame: Up to 1 year
measure: Progressive or New Arterial Thromboembolism
timeFrame: Up to 1 year
measure: Progressive or New Venous Thromboembolic
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: David Garcia
role: PRINCIPAL_INVESTIGATOR
References: