Phase 2 N=19 Treatment

Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Thrombotic Thrombocytopenic Purpura

Bottom Line

View on ClinicalTrials.gov: NCT01554514 ↗

Enrolled (actual)

Serious AEs

58.8%

Results posted

Aug 2021

Primary outcome: Primary: Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP — 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP	2; 0	—
SECONDARY Incidence of Durable Treatment Response	17	—
SECONDARY Number of Days to Durable Treatment Response	5	—
SECONDARY Incidence of Relapse	5	—
SECONDARY Months to Relapse	17.3	—
SECONDARY Incidence of Death	1	—
SECONDARY Treatment-related Adverse Events	13	—

Summary

Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called "plasmapheresis"). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.

Eligibility Criteria

Inclusion Criteria

Age 18 or greater
Diagnosis of suspected thrombotic thrombocytopenic purpura (TTP)
Platelet count of 1 x ULN
Subjects who will receive treatment for TTP with plasma exchange
Subjects who have not started the 5th plasma exchange
Plasma ADAMTS13 activity 180 AND diastolic BP >120, or papilledema
Organ or stem cell transplant
Use of calcineurin inhibitors (sirolimus, tacrolimus, cyclosporin A) within 6 months prior to diagnosis of TTP
Disseminated intravascular coagulation as defined by:

a. INR >2.0 (unrelated to anticoagulation, unresponsive to Vitamin K) or b. Fibrinogen <100 mg/dl

Pregnancy
Known congenital TTP.
Rituximab within the previous year.
HIV history or positive serology
History of hepatitis B or positive serology for HBsAg or Anti-HBc
Persistent or unexplained platelet count below 150,000/μL within 3 months of current TTP presentation
Hypersensitivities or allergies to murine and/or humanized antibodies
Current participation in trials of investigational therapies or devices, other than central catheters

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01554514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.