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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195010
Recruitment Status : Terminated (Terminated because of slow recruitment and lack of funding support)
First Posted : June 22, 2017
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Biological: Platelet Transfusion Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: Platelet Transfusion
Undergo lower dose platelet transfusion
Other Name: Blood Platelet Transfusion
Experimental: 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.
 Biological: Platelet Transfusion
Undergo higher dose platelet transfusion
Other Name: Blood Platelet Transfusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Eligible Patients Approached for the Study [ Time Frame: Up to 1 year ]
  2. Number of Patients Approached for But Refusing Consent [ Time Frame: Up to 1 year ]
    Reasons for ineligibility will be reported qualitatively in order to inform future studies.

  3. Number of Patients Consenting to Enrollment [ Time Frame: Up to 1 year ]
  4. Number of Patients Eligible [ Time Frame: Up to 1 year ]
  5. Number of Patients Screened and Deemed Ineligible [ Time Frame: Up to 1 year ]
    Reasons for ineligibility will be reported qualitatively in order to inform future studies.

  6. Number of Patients Successfully Following Protocol [ Time Frame: Up to 1 year ]
    Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.


Secondary Outcome Measures :
  1. Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater) [ Time Frame: Up to 1 year ]
    Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).

  2. Major Bleeds (World Health Organization Grade 3 or 4) [ Time Frame: Up to 1 year ]
    Will evaluate the major bleeds (World Health Organization grade 3 or 4).

  3. Number of Platelet Transfusions Per Patient During the Study Period [ Time Frame: Up to 1 year ]
  4. Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given) [ Time Frame: Up to 1 year ]
    The frequency with which transfusions are given despite a platelet count above the determined threshold will be documented, as will the frequency with which transfusions are not administered within 24 hours after a platelet count below the determined threshold.

  5. Platelet Transfusion Related Complications [ Time Frame: Up to 1 year ]
    Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.

  6. Progressive or New Arterial Thromboembolism [ Time Frame: Up to 1 year ]
    Will evaluate the progression or new arterial thromboembolism by either documented acute electrocardiographic changes compatible with myocardial injury and/or serum biochemical changes diagnostic of myocardial infarction, or documented imaging (computed tomography or magnetic resonance imaging) changes compatible with infarct due to embolism in the presence of a new neurological deficit, or imaging demonstrated intraluminal filling defects in an arterial distribution accompanied by symptoms of acute ischemia (acute onset pain, pallor, loss of pulses or other end-organ damage).

  7. Progressive or New Venous Thromboembolic [ Time Frame: Up to 1 year ]
    Will evaluate the progressive or new venous thromboembolic. Will require imaging confirmation, defined as intraluminal filling defect(s) on contrast-enhanced computed tomography or incompressible venous segment(s) on ultrasonography.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195010


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David Garcia Fred Hutch/University of Washington Cancer Consortium
  Study Documents (Full-Text)

Documents provided by Fred Hutchinson Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] December 27, 2017

More Information
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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT03195010    
Other Study ID Numbers: 9799
NCI-2017-00864 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9799 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2017    Key Record Dates
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Leukemia, Lymphoid
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
Myeloproliferative Disorders
Embolism and Thrombosis