Purpura, Thrombocytopenic, IdiopathicPhase 3NCT03010202
The PROLONG Trial - Rituximab Maintenance Therapy in ITP
A Phase 3 study testing Dexamethasone and Rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the the effect of Rituximab in immune thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- Dexamethasone and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteNorway
- Study dates
- 11 Jan 2017to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female aged ≥18 years.
- Diagnosis of primary ITP of less than one year duration having a platelet count of ≤ 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve initial response or relapse either after one cycle of dexamethasone (40 mg daily for 4 days) or 4 weeks with any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding.
- Scheduled intravenous treatment of rituximab.
- Signed and dated written informed consent.
- Females of child-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo.
- Inclusion criteria second randomization (maintenance phase):
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- Completion of the induction phase (phase 1) of the study.
- Sustained response at the end of phase 1.
- Randomization within 4 weeks after the completion of phase 1, i.e. between week 24 and 28.
Who cannot join
- Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, aziothioprin, cyclosporine), chemotherapy or splenectomy.
- Pregnancy or lactation.
- Known active gastro-duodenal ulcer.
- Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, autoimmune disorders such as, common variable immune deficiency, human immunodeficiency virus, or hepatitis C or thrombocytopenia associated with myeloid dysplasia.
- Concomitant autoimmune hemolytic anemia.
- History of any major cardiovascular event within the 6 months prior to randomization, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, or New York Heart Association Class III or IV heart failure.
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- Active hepatitis B virus or patients with positive HBsAG or HBcAB.
- Patients with active severe infection, including systemic mycotic infections or a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection.
- Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or any of the ingredients.
- Patients in a severely immune compromised state.
- Known contraindication to a treatment with any proton-pump inhibitor.
- Active malignancy or history of malignant disease during the last 2 years except cured skin cancer.
- Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
- Exclusion criteria second randomization (maintenance phase) 14. Severe allergic reaction or serum sickness due to rituximab in phase 1 of the study.
- 15. Pregnancy. 16. Treatment with rescue medication after week 18. 17. Patients refusing to continue in the study (withdrawal of consent). 18. Splenectomy performed for any cause.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonging the Response by Low-dose Rituximab Maintenance Therapy in Immune Thrombocytopenia: a Randomized Placebo-controlled Trial - the PROLONG Trial
This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the the effect of Rituximab in immune thrombocytopenia.
Read the detailed description
This is a multi-center, international, randomized, two-phase study:
First phase (induction phase) is open-label, hypothesis-generating, involving 1:1 randomization into: rituximab (group 1) or rituximab plus dexamethasone (group 2) to determine if the response to rituximab can be improved by the addition of dexamethasone.
Second Phase (maintenance phase) is the main part of the study, involving 1:1 double-blind randomization into low dose rituximab or placebo to determine if the response achieved in the first phase can be prolonged by administrating maintenance treatment with low dose rituximab.
Primary objective:
To determine if maintenance therapy with low-dose rituximab is superior to placebo in prolonging responses among ITP patients who achieved an initial response with rituximab.
Secondary objectives:
- To explore if the initial overall response rate, at week 24, can be improved by at least 10% by adding dexamethasone to rituximab (induction phase).
- To assess the safety of study treatment, especially infectious episodes (induction \& maintenance phases).
- To assess bleeding complications during the study (induction \& maintenance phases).
- To assess the use of rescue medications and other platelet-elevating therapies during the study (induction \& maintenance phases).
- To determine rate of Complete Response (CR) during induction phase and sustained CR during maintenance phase (induction \& maintenance phases).
- To determine the duration of overall response and CR (induction \& maintenance phases).
- To assess health-related quality of life and fatigue (induction \& maintenance phases).
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- Dexamethasone, Rituximab
- Keywords
- immune thrombocytopenia, rituximab, thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Comparing the effect of Rituximab infusion With or without Dexamethasone
RituximabDrug
Also called Mabthera
Comparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo
| Study group | Role | What they receive |
|---|---|---|
| Induction phase: Rituximab+Dexamethasone | Experimental | Open-label, intravenous infusions of rituximab 1000 mg and oral dexamethasone 20 mg daily for 4 days given on day 1 and day 15. Receives: Drug: Dexamethasone |
| Induction phase: Rituximab | No intervention | Open-label, intravenous infusions of rituximab 1000 mg given on day 1 and day 15. |
| Maintenance phase: Rituximab | Experimental | Patients who respond to rituximab in the induction phase will be proceed into the maintenance phase and randomized to rituximab infusion of 500 mg in week 1 and week 24, or Receives: Drug: Rituximab |
| Maintenance phase: Placebo | No intervention | Infusion of normal saline 0,9% in week 1 ande week 24 in second randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained of overall response
sustained overall response during maintenance phase [loss of overall response is defined as: (1) two consecutive measurements with platelet counts < 50 x 109/L taken at 1-8-week interval, and/or, (2) use of any ITP-directed therapies, other than study medication, because of bleeding or thrombocytopenia, except for preoperative elevation of platelet count] (this endpoint applies to maintenance phase only).
Measured: 52 weeks
Secondary outcomes (8)
Improvement at overall response rate in week 24
Overall response during induction phase defined as mean platelet count, determined in week 24 (± 2 weeks) after induction therapy, > 50 x 10E9/L , without use of any other ITP-directed therapies after week 12 following the first randomization (this endpoint applies to induction phase only).
Measured: Week 24 (+/- 2 weeks)
Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases)
Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases).
Measured: 24 weeks and 52 weeks
Grade of bleeding during the study (during both phases)
Grade of bleeding (this endpoint applies to both phases).
Measured: 24 weeks and 52 weeks
Sustained Complete Response (CR) during maintenance phase
Sustained Complete Response (CR) during maintenance phase defined as platelet count > 100 x 109/L maintained during maintenance phase, without the use of any ITP-directed therapies
Measured: 52 weeks
Complete Response during induction phase
Complete Response (CR) during induction phase defined as platelet count, determined in week 24 (± 2 weeks), > 100 x 109/L without use of any other ITP-directed therapies after week 12 following the first randomization (induction phase)
Measured: 24 weeks (+/- 2 weeks)
Rescue medication or other elevating platelet therapy
Administration of rescue medication or other elevating platelet therapy
- After week 12 (induction phase)
- During maintenance phase (maintenance phase).
Measured: after 12 weeks in induction phase and 40 weeks in maintenance phase
Platelet count Levels > 50 x 109/L during maintenance phase
Percentage of patients with more than 80% of platelet counts level > 50 x 109/L during the maintenance phase (this endpoint applies to maintenance phase only).
Measured: phase 2 (52 weeks)
Health related quality of life
Health-related quality of life assessed by SF-36 questionnaire (this endpoint applies to both phases).
Measured: First phase at 24 weeks and second phase at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start11 Jan 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, St. Olavs Hospital, Helse Stavanger HF, University Hospital of North Norway, Haukeland University Hospital, Odense University Hospital, Centre Hôpital Universitaire Farhat Hached, Henri Mondor University Hospital, University Hospital, Akershus, Hospital Militaire Principal d'Instruction de Tunis, Centre Hospitalier Universitaire Dijon, IUCT Oncopole (Toulouse), Kasr El Aini Hospital, Hôpital Haut-Leveque, Bordeaux, France, Hopital La Rabta
- Responsible party
- Sponsor
- Investigators
- Waleed Ghanima, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010202
- Sponsor's protocol ID
- RGCH004
- Status last verified
- Sep 2026
- First submitted
- 28 Dec 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonging the Response by Low-dose Rituximab Maintenance Therapy in Immune Thrombocytopenia: a Randomized Placebo-controlled Trial - the PROLONG Trial
- ClinicalTrials.gov ID
- NCT03010202
- Acronym / sponsor ID
- RGCH004
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- immune thrombocytopenia, rituximab, thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, St. Olavs Hospital, Helse Stavanger HF, University Hospital of North Norway, Haukeland University Hospital, Odense University Hospital, Centre Hôpital Universitaire Farhat Hached, Henri Mondor University Hospital, University Hospital, Akershus, Hospital Militaire Principal d'Instruction de Tunis, Centre Hospitalier Universitaire Dijon, IUCT Oncopole (Toulouse), Kasr El Aini Hospital, Hôpital Haut-Leveque, Bordeaux, France, Hopital La Rabta
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the the effect of Rituximab in immune thrombocytopenia.
Detailed description
This is a multi-center, international, randomized, two-phase study:
First phase (induction phase) is open-label, hypothesis-generating, involving 1:1 randomization into: rituximab (group 1) or rituximab plus dexamethasone (group 2) to determine if the response to rituximab can be improved by the addition of dexamethasone.
Second Phase (maintenance phase) is the main part of the study, involving 1:1 double-blind randomization into low dose rituximab or placebo to determine if the response achieved in the first phase can be prolonged by administrating maintenance treatment with low dose rituximab.
Primary objective:
To determine if maintenance therapy with low-dose rituximab is superior to placebo in prolonging responses among ITP patients who achieved an initial response with rituximab.
Secondary objectives:
- To explore if the initial overall response rate, at week 24, can be improved by at least 10% by adding dexamethasone to rituximab (induction phase).
- To assess the safety of study treatment, especially infectious episodes (induction \& maintenance phases).
- To assess bleeding complications during the study (induction \& maintenance phases).
- To assess the use of rescue medications and other platelet-elevating therapies during the study (induction \& maintenance phases).
- To determine rate of Complete Response (CR) during induction phase and sustained CR during maintenance phase (induction \& maintenance phases).
- To determine the duration of overall response and CR (induction \& maintenance phases).
- To assess health-related quality of life and fatigue (induction \& maintenance phases).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Induction phase: Rituximab+Dexamethasone | Experimental | Drug: DexamethasoneOpen-label, intravenous infusions of rituximab 1000 mg and oral dexamethasone 20 mg daily for 4 days given on day 1 and day 15. |
| Induction phase: Rituximab | No intervention | –Open-label, intravenous infusions of rituximab 1000 mg given on day 1 and day 15. |
| Maintenance phase: Rituximab | Experimental | Drug: RituximabPatients who respond to rituximab in the induction phase will be proceed into the maintenance phase and randomized to rituximab infusion of 500 mg in week 1 and week 24, or |
| Maintenance phase: Placebo | No intervention | –Infusion of normal saline 0,9% in week 1 ande week 24 in second randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged ≥18 years.
- Diagnosis of primary ITP of less than one year duration having a platelet count of ≤ 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve initial response or relapse either after one cycle of dexamethasone (40 mg daily for 4 days) or 4 weeks with any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding.
- Scheduled intravenous treatment of rituximab.
- Signed and dated written informed consent.
- Females of child-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo.
Key exclusion criteria (16 listed)
- Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, aziothioprin, cyclosporine), chemotherapy or splenectomy.
- Pregnancy or lactation.
- Known active gastro-duodenal ulcer.
- Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, autoimmune disorders such as, common variable immune deficiency, human immunodeficiency virus, or hepatitis C or thrombocytopenia associated with myeloid dysplasia.
- Concomitant autoimmune hemolytic anemia.
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 |
|---|---|---|
| DexamethasoneComparing the effect of Rituximab infusion With or without Dexamethasone | Drug | Induction phase: Rituximab+Dexamethasone |
| RituximabAlso: MabtheraComparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo | Drug | Maintenance phase: Rituximab |
Primary outcome
Sustained of overall response
Time frame: 52 weeks
sustained overall response during maintenance phase [loss of overall response is defined as: (1) two consecutive measurements with platelet counts < 50 x 109/L taken at 1-8-week interval, and/or, (2) use of any ITP-directed therapies, other than study medication, because of bleeding or thrombocytopenia, except for preoperative elevation of platelet count] (this endpoint applies to maintenance phase only).
8 secondary outcomes
Improvement at overall response rate in week 24
Time frame: Week 24 (+/- 2 weeks)
Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases)
Time frame: 24 weeks and 52 weeks
Grade of bleeding during the study (during both phases)
Time frame: 24 weeks and 52 weeks
Sustained Complete Response (CR) during maintenance phase
Time frame: 52 weeks
Complete Response during induction phase
Time frame: 24 weeks (+/- 2 weeks)
Rescue medication or other elevating platelet therapy
Time frame: after 12 weeks in induction phase and 40 weeks in maintenance phase
Platelet count Levels > 50 x 109/L during maintenance phase
Time frame: phase 2 (52 weeks)
Health related quality of life
Time frame: First phase at 24 weeks and second phase at 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Waleed Ghanima, PhD principal investigator
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by Ostfold Hospital Trust at 1 site in Norway.
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 9 inclusion and 16 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sustained of overall response (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.