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A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05284032
Recruitment Status : Not yet recruiting
First Posted : March 17, 2022
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Firas El Chaer, MD, University of Virginia

Brief Summary:
Some of the treatments for cancer can cause platelets (the part of the blood that helps with clotting) to decrease. If they are too low, then clinicians may recommend a transfusion (getting platelets from another person added to someone else's body). This usually works to increase the person's platelets to a healthy level, but sometimes it doesn't work. This is called platelet refractoriness. This study is trying to find out whether isatuximab (the study drug) may help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.

Condition or disease Intervention/treatment Phase
Platelet Refractoriness Hematologic Malignancy Drug: isatuximab 10 mg/kg Early Phase 1

Detailed Description:
Participants in this study will receive 4 weekly infusions of the study drug, isatuximab, by intravenous infusion. The dose of isatuximab infusions may be larger or smaller and take a longer or shorter time to infuse depending on your weight and time required will decrease from the first to second infusion and from the second to third and fourth infusion. Participants will be observed for 2 hours after each infusion. Participants will continue to receive platelet transfusions according to standard clinical care and will be followed for about 120 days after their last dose of isatuximab.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : October 15, 2023
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Isatuximab

Arm Intervention/treatment
Experimental: Isatuximab (Sarclisa)
4 weekly doses of isatuximab
Drug: isatuximab 10 mg/kg
Given by intravenous infusion




Primary Outcome Measures :
  1. Percent panel-reactive antibodies (PRAs)- change over time/with study treatment [ Time Frame: Through about 120 days following last study drug infusion ]
    A weighted percent of class I HLA targets to which the patient has made antibodies


Secondary Outcome Measures :
  1. Mean fluorescence intensity (MFI) - change over time/ with study treatment [ Time Frame: Through about 120 days following last study drug infusion ]
    MFI of each class I anti-HLA antibody contributing to the %PRA

  2. Quality of life - changes over time/with study treatment according to the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) [ Time Frame: Through about 120 days following last study drug infusion ]
    Each question is scored on a 5-point scale (0 - 4), with a mixture of questions scored with low numbers indicating better quality of life and others indicating worse quality

  3. Adverse events [ Time Frame: Through about 30 days following last study drug infusion ]
    Frequency, severity (by CTCAE v5), and duration of Grade 3 or higher adverse events considered related to the study intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, age ≥ 18 years
  4. Diagnosis of a hematologic malignancy
  5. Diagnosis of immune mediated platelet transfusion refractoriness secondary to class I anti-HLA antibodies:

    1. Lack of adequate post-transfusion platelet corrected count increment (CCI), defined by CCI <7500/uL at 10-60 minutes post transfusion, after at least 2 consecutive general inventory AP unit transfusions.
    2. Calculated percent panel-reactive antibodies (%PRA) > 80%
  6. Adequate Organ Function:

    • serum creatinine <= 1.5 x upper limit of normal
    • bilirubin <= 1.5 x upper limit of normal (exceptions for Gilbert's disease)
    • AST and ALT <= 2.5 x upper limit of normal
    • Alkaline phosphatase <= 2.5 x upper limit of normal
  7. For females and males of reproductive potential: agreement to use adequate contraception (see section 5.3)
  8. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration

Exclusion Criteria:

  1. Immune-mediated platelet refractoriness other than anti-HLA antibody-mediated
  2. Non-immune-mediated platelet refractoriness (e.g. splenomegaly or disseminated intravascular coagulation)
  3. Diagnosis of thrombocytopenia induced by other drugs, such as vancomycin, heparin, or amphotericin
  4. Diagnosis of thrombotic thrombocytopenic purpura or idiopathic immune thrombocytopenia
  5. Active bleeding
  6. Greater than Grade 2 active graft versus host disease (GVHD) following allogeneic HSCT
  7. Bi-directional ABO mismatched allogeneic stem cell transplantation
  8. Prior administration of daratumumab, isatuximab or any other anti-CD38 antibodies
  9. Known uncontrolled HIV disease and/or active Hepatitis A, B, or C infection
  10. Active systemic infection and severe infections requiring treatment with a parenteral administration of antimicrobials.

    • Controlled systemic infections on antimicrobial therapy that are stable at the time of screening are not an exclusion criterion.
  11. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
  12. Received any investigational drug within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention, whichever is longer. In case of very aggressive disease (i.e acute leukemia) delay could be shortened after agreement between sponsor and investigator, in absence of residual toxicities from previous therapy
  13. Pregnancy or lactation
  14. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results.
  15. Current receipt of, or expectation to require anti-CD20 therapy, proteasome inhibitors, intravenous immune globulin ("IVIG"), and plasma exchange therapy during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05284032


Contacts
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Contact: Danyelle Coley 14349825027 JCS6RZ@hscmail.mcc.virginia.edu
Contact: Wyatt Kilburn 4349249496 CBN9UB@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Contact: Danyelle Coley    434-982-5027    JCS6RZ@hscmail.mcc.virginia.edu   
Contact: Wyatt Kilburn    4349249496    CBN9UB@hscmail.mcc.virginia.edu   
Principal Investigator: Firas E Chaer, MD         
Sponsors and Collaborators
Firas El Chaer, MD
Investigators
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Principal Investigator: Firas El Chaer, MD UVA
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Responsible Party: Firas El Chaer, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT05284032    
Other Study ID Numbers: HSR210463
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases