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

NCT03195010 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 9799NCI-2017-00864P30CA015704
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Number of Eligible Patients Approached for the Study

  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.

  Up to 1 year

• Number of Patients Consenting to Enrollment

  Up to 1 year

• Number of Patients Eligible

  Up to 1 year

• Number of Patients Screened and Deemed Ineligible

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

  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.

  Up to 1 year

Secondary Outcomes (7)

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

  Up to 1 year

• Major Bleeds (World Health Organization Grade 3 or 4)

  Up to 1 year

• Number of Platelet Transfusions Per Patient During the Study Period

  Up to 1 year

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

  Up to 1 year

• Platelet Transfusion Related Complications

  Up to 1 year

Study Arms (2)

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.

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.

Biological: Platelet Transfusion

Interventions

Platelet Transfusion BIOLOGICAL

Undergo lower dose platelet transfusion

Also known as: Blood Platelet Transfusion

Group I (lower dose platelet transfusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

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; Primary Myelofibrosis; Lymphoma, T-Cell; Thrombocytopenia; Venous Thromboembolism

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma, Non-Hodgkin; Lymphoma; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myeloproliferative Disorders; Bone Marrow Diseases; Blood Platelet Disorders; Cytopenia; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr Bethany Samuelson Bannow
• Organization: FHCRC

samuelsb@ohsu.edu

5034949925

Study Officials

• David Garcia

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 22, 2017
• Study Start: June 9, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Locations

US (1)