Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
| Registry | NCT03195010 |
|---|---|
| Status | Terminated - Terminated because of slow recruitment and lack of funding support |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 4 (Actual) |
| Sponsor | Fred Hutchinson Cancer Center (Other); collaborators: National Cancer Institute (NCI) |
| 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 |
| Interventions | Platelet Transfusion (Biological) |
| Dates | start 2017-06-09, primary completion 2018-12-21, completion 2018-12-21, first posted 2017-06-22, last updated 2019-10-21 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group I (lower dose platelet transfusion) | Experimental | Biological: 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. |
| Group II (higher dose platelet transfusion) | Experimental | Biological: 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. |
Sex: All, ages: 18 Years to any
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
| Milestone | Group I (Lower Dose Platelet Transfusion) | Group II (Higher Dose Platelet Transfusion) |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
Time frame: On study time (varied between subjects)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Group I (Lower Dose Platelet Transfusion) | 0/2 (0.0%) | 0/2 (0.0%) | 1/2 (50.0%) |
| Group II (Higher Dose Platelet Transfusion) | 0/2 (0.0%) | 0/2 (0.0%) | 2/2 (100.0%) |
| Term | Organ system | Group I (Lower Dose Platelet Transfusion) | Group II (Higher Dose Platelet Transfusion) |
|---|---|---|---|
| mucositis | Gastrointestinal disorders | 1/2 | 2/2 |
| transaminitis | Gastrointestinal disorders | 0/2 | 1/2 |
| Facility | City | Country | Status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle, Washington | United States |
NIH grants: P30CA015704