Idiopathic Thrombocytopenic PurpuraPhase 3NCT00770562

A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

A Phase 3 study testing rituximab and Dexamethasone in people with Idiopathic Thrombocytopenic Purpura, run by Hoffmann-La Roche at 22 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Idiopathic Thrombocytopenic Purpura
What is being tested?: rituximab and Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 22 sitesItaly
Study dates: Jul 2005to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients >=18 years of age;
untreated ITP.

Who cannot join

ITP with relapse;
positive test result for HIV or hepatitis B or C;
active infection requiring systemic therapy;
malignancy within 3 years before study.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Italy22 sites

Study site
Bari, 70124
Study site
Bologna, 40138
Study site
Brescia, 25123
Study site
Cagliari, 09121
Study site
Cuneo, 12100
Study site
Genova, 16132
Study site
Milan, 20162
Study site
Naples, 80131
Study site
Padova, 35128
Study site
Palermo, 90146
Study site
Pavia, 27100
Study site
Pesaro, 61100
Study site
Pescara, 65100
Study site
Ravenna, 48100
Study site
Reggio Emilia, 42100
Study site
Roma, 00133
Study site
Roma, 00161
Study site
Roma, 00168
Study site
Siena, 53100
Study site
Taranto, 74100
Study site
Udine, 33100
Study site
Verona, 37130

Other trials in Italy

About this study

Official title: A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura

Conditions: Idiopathic Thrombocytopenic Purpura
Being tested: rituximab, Dexamethasone
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rituximabDrug
Also called MabThera/Rituxan
DexamethasoneDrug

Study groups in NCT00770562
Study group	Role	What they receive
Dexamethasone	Active comparator	Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Receives: Drug: Dexamethasone
Dexamethasone plus Rituximab	Experimental	Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28. Receives: Drug: rituximab; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Sustained Response
Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.
Measured: Week 24

Secondary outcomes (2)

Percentage of Participants With an Initial Response
Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.
Measured: Week 4
Percentage of Participants With an Initial Complete Response
Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Jul 2008

First posted10 Oct 2008 (estimated)
Study startJul 2005
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770562
Sponsor's protocol ID: ML18542
Status last verified: Oct 2014
First submitted: 9 Oct 2008
Last updated: 22 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.
PubMed 20130241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)

All Idiopathic Thrombocytopenic Purpura trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura
ClinicalTrials.gov ID: NCT00770562
Acronym / sponsor ID: ML18542
Conditions: Idiopathic Thrombocytopenic Purpura
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 10 Oct 2008 (estimated)
Results: Posted 22 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dexamethasone	Active comparator	Drug: DexamethasoneParticipants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
Dexamethasone plus Rituximab	Experimental	Drug: rituximab, Drug: DexamethasoneParticipants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

adult patients >=18 years of age;
untreated ITP.

Key exclusion criteria (4 listed)

ITP with relapse;
positive test result for HIV or hepatitis B or C;
active infection requiring systemic therapy;
malignancy within 3 years before study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rituximabAlso: MabThera/Rituxan	Drug	Dexamethasone plus Rituximab
Dexamethasone	Drug	Dexamethasone, Dexamethasone plus Rituximab

Primary outcome

Percentage of Participants With a Sustained Response
Time frame: Week 24
Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.

2 secondary outcomes

Percentage of Participants With an Initial Response
Time frame: Week 4
Percentage of Participants With an Initial Complete Response
Time frame: Week 4

Results and safety

Results posted to the registry on 22 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Dexamethasone	53	52
Arm B: Dexamethasone + Rituximab	50	49

Primary outcome: Percentage of Participants With a Sustained Response

Time frame: Week 24. Number. Unit: percentage of participants

Measure	Arm A: Dexamethasone n = 52	Arm B: Dexamethasone + Rituximab n = 49
Value	36	63

Arm A: Dexamethasone vs Arm B: Dexamethasone + Rituximab: p = 0.004, Fisher Exact

Population analysed: The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (\<) 1 dose of study medication, and who had at least 1 follow-up contact.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Dexamethasone	1 of 52 (1.9%)	25 of 52 (48.1%)	Not reported
Arm B: Dexamethasone + Rituximab	3 of 49 (6.1%)	37 of 49 (75.5%)	Not reported
Salvage Therapy	3 of 27 (11.1%)	18 of 27 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20130241Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.

Related trials for Idiopathic Thrombocytopenic Purpura

RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study chair

Hoffmann-La Roche

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab and Dexamethasone in people with Idiopathic Thrombocytopenic Purpura, run by Hoffmann-La Roche at 22 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Sustained Response (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770562, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.