Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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This is a pilot safety/efficacy study of adjuvant low dose rituximab (100 mg/week x 4 doses) plus standard plasma exchange and corticosteroids for the treatment of thrombotic thrombocytopenic purpura (TTP) with severe ADAMTS13 deficiency. Results for study subjects will be compared to historical controls treated initially with plasma exchange and corticosteroids. This study proposes to test the hypothesis that adjuvant low dose rituximab may decrease the incidence of a composite primary endpoint (exacerbations or refractory disease) in acquired TTP with severe ADAMTS13 deficiency. A novel ADAMTS13 assay will be used to identify patients with TTP and severe ADAMTS13 deficiency for enrollment, and to assess the utility of ADAMST13 as a biomarker for response to therapy and prognosis.

Conditions

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Thrombotic Thrombocytopenic Purpura

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low dose rituximab

this is a single-arm trial

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

rituximab intravenously 100 mg every week for four doses

Interventions

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rituximab

rituximab intravenously 100 mg every week for four doses

Intervention Type BIOLOGICAL

Other Intervention Names

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Rituxan

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or greater
2. Diagnosis of suspected thrombotic thrombocytopenic purpura (TTP)

1. Platelet count of \< 80,000 for newly diagnosed patients and \< 120,000 for relapsed patients
2. Microangiopathic hemolytic anemia with RBC fragmentation
3. LDH \>1 x ULN
3. Subjects who will receive treatment for TTP with plasma exchange
4. Subjects who have not started the 5th plasma exchange
5. Plasma ADAMTS13 activity \<10%

Exclusion Criteria

1. Treatment for TTP within the past 2 months
2. Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures) or clinical evidence of enteric infection with E. coli O157:H7 or related organism
3. Currently under treatment for cancer (subjects with localized skin carcinoma will be accepted)
4. Microangiopathic hemolytic anemia due to a mechanical heart valve
5. Severe hypertension, as defined by systolic BP \>180 AND diastolic BP \>120, or papilledema
6. Organ or stem cell transplant
7. Use of calcineurin inhibitors (sirolimus, tacrolimus, cyclosporin A) within 6 months prior to diagnosis of TTP
8. Disseminated intravascular coagulation as defined by:

a. INR \>2.0 (unrelated to anticoagulation, unresponsive to Vitamin K) or b. Fibrinogen \<100 mg/dl
9. Pregnancy
10. Known congenital TTP.
11. Rituximab within the previous year.
12. HIV history or positive serology
13. History of hepatitis B or positive serology for HBsAg or Anti-HBc
14. Persistent or unexplained platelet count below 150,000/μL within 3 months of current TTP presentation
15. Hypersensitivities or allergies to murine and/or humanized antibodies
16. Current participation in trials of investigational therapies or devices, other than central catheters

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No