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Clinical Trial Detail

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

Complete title: Management of Venous Thromboembolic Events (VTE) in Patients with Hematologic Disorders and Treatment-Induced Thrombocytopenia: a Pilot Study

Research Study Number 9799
Principal Investigator David Garcia
Phase II

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

** This study is enrolling participants by invitation only **

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number 9799
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Lymphoma; Lymphoproliferative Disorders; Myelodysplastic Syndromes (MDS); Lymphoma, Non-Hodgkin (NHL); Leukemia, Myeloid; Leukemia, Lymphoid; Immunoproliferative Disorders; Lymphoma, B-Cell; Lymphoma, T-Cell; Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Preleukemia; Bone Marrow Diseases; Thrombocythemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Immune System Diseases; Venous Thromboembolism

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