Phase 2
Completed N=19
Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura
Source: ClinicalTrials.gov NCT01554514 ↗Enrolled (actual)
19
Serious AEs
58.8%
Results posted
Aug 2021
Primary outcomePrimary: Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP — 2; 0 Participants
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.
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 | — |
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
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. Informational only — not medical advice.