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Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)

ConditionsImmune ThrombocytopeniaTreatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥60 years, male or female.

Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.

Patients have failed glucocorticoid therapy and at least one standard second-line therapy. (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and/or intravenous human immunoglobulin) (PLT≥50×10^9/L);

Platelet count <30×10^9/L within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count <30×10^9/L and no platelet count > 35×10^9/L.

Disqualifiers

Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.

All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.

Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.

Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • Daratumumab Injection

    Drug

    This study adopts a prospective, single arm, open design method. Thirty subjects were enrolled in the study and were treated with CD38 monoclonal antibody (Daratumumab 16mg/kg/w) for 4 weeks. The first stage is the main research stage (d1-w4), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Daratumumab once a week for 4 weeks to observe the safety and efficacy during treatment. The second stage (w5-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Daratumumab after treatment.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intervention (Daratumumab)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events of Anti-CD38 antibody treatment

Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD38 antibody treatment

Time frame
24 weeks
2

Efficacy after Daratumumab treatment within 8 weeks

Evaluation of ORR (overall response rate) within 8 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RAs or corticosteroids during the study period

Time frame
8 weeks

Secondary outcomes

1

CR (complete remission) ratios at each visit time point

Evaluation of CR（complete remission) ratios at each visit time point after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RAs or corticosteroids during the study period

Time frame
24 weeks
2

ORR (overall response rate) at each visit time point

Evaluation of ORR (overall response rate) at each visit time point after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RAs or corticosteroids during the study period

Time frame
24 weeks
3

Other efficacy evaluation

Proportion of subjects achieving platelet counts ≥ 50×10\^9/L at least once in absence of rescue therapy, and without having had dose increment of TPO-RAs or corticosteroids at each visit time poin

Time frame
24 weeks
4

Time to response (TTR)

Duration from treatment initiation to platelet count ≥30×10\^9/L and at least twice the baseline without having received any platelet elevating therapy or having had dose increment of TPO-RAs and/or corticosteroids

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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