NCT00907751

Brief Summary

Multicentric non-randomized phase II opened prospective study (10 centres involved). Primary endpoint:

  • To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges. Secondary endpoints:
  • To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
  • To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

May 22, 2009

Last Update Submit

February 26, 2014

Conditions

Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges

    at 1, 3, 6, 9, 12, 18 and 24 months

Secondary Outcomes (2)

  • To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion

    at 1, 3, 6, 9, 12, 18 and 24 months

  • To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

    at 1, 3, 6, 9, 12, 18 and 24 months

Study Arms (1)

1

EXPERIMENTAL

Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia (\<50 G/L)

Drug: rituximab

Interventions

rituximabDRUG

Patients will be treated according to the recommendations of the Reference Centre for the management of thrombotic microangiopathies. Infusions of rituximab (375 mg/m2) will be added to this treatment at day 1, 4 and 15, immediately after plasma exchange sessions.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia \<50 G/L, and mild or no renal failure (Serum creatinine \< 150 µmol/L),
  • negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,
  • refractory TTP (after 4 days of standard treatment)
  • \> 18 year old
  • and signed written informed consent.

You may not qualify if:

  • Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),
  • TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),
  • ongoing or planned pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Antoine Hospital, Hematology

Paris, 75012, France

Location

Related Publications (1)

  • Benhamou Y, Paintaud G, Azoulay E, Poullin P, Galicier L, Desvignes C, Baudel JL, Peltier J, Mira JP, Pene F, Presne C, Saheb S, Deligny C, Rousseau A, Feger F, Veyradier A, Coppo P; French Reference Center for Thrombotic Microangiopathies. Efficacy of a rituximab regimen based on B cell depletion in thrombotic thrombocytopenic purpura with suboptimal response to standard treatment: Results of a phase II, multicenter noncomparative study. Am J Hematol. 2016 Dec;91(12):1246-1251. doi: 10.1002/ajh.24559. Epub 2016 Nov 8.

    PMID: 27643485DERIVED

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Paul COPPO, Md Ph D

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 25, 2009

Study Start

May 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

FR(1)