- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284032
A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)
August 3, 2023 updated by: Firas El Chaer, MD
A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
17
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Taylor Durham
- Phone Number: 434-243-4281
- Email: CRZ7DS@uvahealth.org
Study Contact Backup
- Name: Cory Caldwell
- Phone Number: 434-297-4182
- Email: CJC2P@uvahealth.org
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia
-
Contact:
- Taylor O Durham
- Phone Number: 434-243-4281
- Email: CRZ7DS@uvahealth.org
-
Principal Investigator:
- Firas E Chaer, MD
-
Contact:
- Cory Caldwell
- Phone Number: 434-297-4182
- Email: CJC2P@uvahealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age ≥ 18 years
- Diagnosis of immune mediated platelet transfusion refractoriness secondary to class I anti-HLA antibodies according to institutional practice, including calculated percent panel-reactive antibodies (%PRA) > 80%
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
- For females and males of reproductive potential: agreement to use adequate contraception (see section 5.3)
- Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration
Exclusion Criteria:
- Immune-mediated platelet refractoriness other than anti-HLA antibody-mediated
- Non-immune-mediated platelet refractoriness (e.g. splenomegaly or disseminated intravascular coagulation)
- Diagnosis of thrombocytopenia induced by other drugs, such as vancomycin, heparin, or amphotericin
- Diagnosis of thrombotic thrombocytopenic purpura or idiopathic immune thrombocytopenia
- Active bleeding
- Greater than Grade 2 active graft versus host disease (GVHD) following allogeneic HSCT
- Bi-directional ABO mismatched allogeneic stem cell transplantation
- Prior administration of daratumumab, isatuximab or any other anti-CD38 antibodies
- Known uncontrolled HIV disease and/or active Hepatitis A, B, or C infection
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.
- 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.
- 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
- Pregnancy or lactation
- 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.
- Current receipt of, or expectation to require anti-CD20 therapy, proteasome inhibitors, intravenous immune globulin ("IVIG"), and plasma exchange therapy during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isatuximab (Sarclisa)
4 weekly doses of isatuximab
|
Given by intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through about 120 days following last study drug infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through about 120 days following last study drug infusion
|
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
|
Through about 120 days following last study drug infusion
|
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
|
Through about 30 days following last study drug infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Firas El Chaer, MD, UVA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2022
Primary Completion (Estimated)
January 15, 2025
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 3, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR210463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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