Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
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|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
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|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|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|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|
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
- Number of Eligible Patients Approached for the Study [ Time Frame: Up to 1 year ]
- 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.
- Number of Patients Consenting to Enrollment [ Time Frame: Up to 1 year ]
- Number of Patients Eligible [ Time Frame: Up to 1 year ]
- 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.
- 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.
- 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).
- 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).
- Number of Platelet Transfusions Per Patient During the Study Period [ Time Frame: Up to 1 year ]
- 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.
- Platelet Transfusion Related Complications [ Time Frame: Up to 1 year ]Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.
- 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).
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||David Garcia||Fred Hutch/University of Washington Cancer Consortium|
Documents provided by Fred Hutchinson Cancer Center:
|Responsible Party:||Fred Hutchinson Cancer Center|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
Immune System Diseases
Bone Marrow Diseases
Embolism and Thrombosis