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

Primary Purpose

Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Platelet Transfusion

About this trial

This is an interventional supportive care trial for Acute Biphenotypic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group I (lower dose platelet transfusion)

Group II (higher dose platelet transfusion)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Eligible Patients Approached for the Study

Number of Patients Approached for But Refusing Consent

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Number of Patients Consenting to Enrollment

Number of Patients Eligible

Number of Patients Screened and Deemed Ineligible

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Number of Patients Successfully Following Protocol

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

Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)

Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).

Major Bleeds (World Health Organization Grade 3 or 4)

Will evaluate the major bleeds (World Health Organization grade 3 or 4).

Number of Platelet Transfusions Per Patient During the Study Period

Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)

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

Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.

Progressive or New Arterial Thromboembolism

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

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.

Full Information

NCT ID

NCT03195010

First Posted

June 13, 2017

Last Updated

October 17, 2019

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03195010

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Why Stopped

Terminated because of slow recruitment and lack of funding support

Study Start Date

June 9, 2017 (Actual)

Primary Completion Date

December 21, 2018 (Actual)

Study Completion Date

December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I (lower dose platelet transfusion)

Arm Type

Experimental

Arm Description

Arm Title

Group II (higher dose platelet transfusion)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Platelet Transfusion

Other Intervention Name(s)

Blood Platelet Transfusion

Intervention Description

Undergo lower dose platelet transfusion

Intervention Type

Biological

Intervention Name(s)

Platelet Transfusion

Other Intervention Name(s)

Blood Platelet Transfusion

Intervention Description

Undergo higher dose platelet transfusion

Primary Outcome Measure Information:

Title

Number of Eligible Patients Approached for the Study

Time Frame

Up to 1 year

Title

Number of Patients Approached for But Refusing Consent

Description

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Time Frame

Up to 1 year

Title

Number of Patients Consenting to Enrollment

Time Frame

Up to 1 year

Title

Number of Patients Eligible

Time Frame

Up to 1 year

Title

Number of Patients Screened and Deemed Ineligible

Description

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Time Frame

Up to 1 year

Title

Number of Patients Successfully Following Protocol

Description

Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)

Description

Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).

Time Frame

Up to 1 year

Title

Major Bleeds (World Health Organization Grade 3 or 4)

Description

Will evaluate the major bleeds (World Health Organization grade 3 or 4).

Time Frame

Up to 1 year

Title

Number of Platelet Transfusions Per Patient During the Study Period

Time Frame

Up to 1 year

Title

Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)

Description

Time Frame

Up to 1 year

Title

Platelet Transfusion Related Complications

Description

Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.

Time Frame

Up to 1 year

Title

Progressive or New Arterial Thromboembolism

Description

Time Frame

Up to 1 year

Title

Progressive or New Venous Thromboembolic

Description

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Garcia

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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