Acute Biphenotypic LeukemiaPhase 2NCT03195010
Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
A Phase 2 study testing Platelet Transfusion in people with Acute Biphenotypic Leukemia and Acute Lymphoblastic Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Platelet Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 21 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, B-Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Being tested
- Platelet Transfusion
- Medical subject headings
- Leukemia, Biphenotypic, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Diseases, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet TransfusionBiological
Also called Blood Platelet Transfusion
Undergo lower dose platelet transfusion
Platelet TransfusionBiological
Also called Blood Platelet Transfusion
Undergo higher dose platelet transfusion
| Study group | Role | What they receive |
|---|---|---|
| Group I (lower dose platelet transfusion) | Experimental | 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. Receives: Biological: Platelet Transfusion |
| Group II (higher dose platelet transfusion) | Experimental | 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. Receives: Biological: Platelet Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eligible Patients Approached for the Study
Measured: Up to 1 year
Number of Patients Approached for But Refusing Consent
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Measured: Up to 1 year
Number of Patients Consenting to Enrollment
Measured: Up to 1 year
Number of Patients Eligible
Measured: Up to 1 year
Number of Patients Screened and Deemed Ineligible
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Secondary outcomes (7)
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).
Measured: Up to 1 year
Major Bleeds (World Health Organization Grade 3 or 4)
Will evaluate the major bleeds (World Health Organization grade 3 or 4).
Measured: Up to 1 year
Number of Platelet Transfusions Per Patient During the Study Period
Measured: Up to 1 year
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.
Measured: Up to 1 year
Platelet Transfusion Related Complications
Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.
Measured: Up to 1 year
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).
Measured: Up to 1 year
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start9 Jun 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Why it stopped: Terminated because of slow recruitment and lack of funding support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Biphenotypic LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Garcia, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195010
- Sponsor's protocol ID
- 9799
- Other IDs
- NCI-2017-00864, 9799, P30CA015704
- Status last verified
- Oct 2019
- First submitted
- 13 Jun 2017
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
- ClinicalTrials.gov ID
- NCT03195010
- Acronym / sponsor ID
- 9799
- Conditions
- Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, B-Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated because of slow recruitment and lack of funding support
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (lower dose platelet transfusion) | Experimental | Biological: Platelet TransfusionPatients 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 platelet transfusion) | Experimental | Biological: Platelet TransfusionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet TransfusionAlso: Blood Platelet TransfusionUndergo lower dose platelet transfusion | Biological | Group I (lower dose platelet transfusion) |
| Platelet TransfusionAlso: Blood Platelet TransfusionUndergo higher dose platelet transfusion | Biological | Group II (higher dose platelet transfusion) |
Primary outcome
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.
7 secondary outcomes
Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)
Time frame: Up to 1 year
Major Bleeds (World Health Organization Grade 3 or 4)
Time frame: Up to 1 year
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
Platelet Transfusion Related Complications
Time frame: Up to 1 year
Progressive or New Arterial Thromboembolism
Time frame: Up to 1 year
Progressive or New Venous Thromboembolic
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Garcia principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Transfusion in people with Acute Biphenotypic Leukemia and Acute Lymphoblastic Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eligible Patients Approached for the Study (time frame: Up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.