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Trial record 1 of 1 for:    Adjuvant Rituximab in TTP
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Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554514
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date October 2, 2019
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
Incidence of the composite primary outcome of exacerbation or refractory TTP [ Time Frame: 60 days ]
Exacerbation is recurring TTP ≤30 days after a Treatment Response (normal platelet count for 2 days) and discontinuation of plasma exchange. Refractory TTP is failure to achieve a Treatment Response by day 28, or failure to achieve a Durable Treatment Response (lasting at least 30 days) by day 60.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01554514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Incidence of Durable Treatment Response [ Time Frame: 60 days ]
    Treatment Response is 2 consecutive days with platelet count ≥150, 000/µL Durable Treatment Response is a Treatment Response that persists for ≥30 days after discontinuation of plasma exchange
  • Number of days to Durable Treatment Response [ Time Frame: 60 days ]
  • Incidence of Relapse [ Time Frame: 2 years ]
    Relapse is recurring TTP >30 days after Treatment Response
  • Number of days to Relapse [ Time Frame: 2 years ]
  • Incidence of death [ Time Frame: 2 years ]
    Incidence of death will be assessed at 4 weeks, 1 year and 2 years
  • Treatment-related adverse events [ Time Frame: 2 years ]
    Incidence, type and severity of treatment-related adverse events will be assessed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura
Official Title  ICMJE Adjuvant Low Dose Rituximab for Acquired TTP With Severe ADAMTS13 Deficiency
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombotic Thrombocytopenic Purpura
Intervention  ICMJE Biological: rituximab
rituximab intravenously 100 mg every week for four doses
Other Name: Rituxan
Study Arms  ICMJE Experimental: low dose rituximab
this is a single-arm trial
Intervention: Biological: rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
19
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
20
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554514
Other Study ID Numbers  ICMJE LDrituximab
1U54HL112303-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Elaine M Majerus, MD, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP