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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 November 2023 |
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Main ID: |
NCT03010202 |
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Date of registration:
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28/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The PROLONG Trial - Rituximab Maintenance Therapy in ITP
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Scientific title:
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Prolonging the Response by Low-dose Rituximab Maintenance Therapy in Immune Thrombocytopenia: a Randomized Placebo-controlled Trial - the PROLONG Trial |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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136 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03010202 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Norway
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Contacts
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Name:
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Waleed Ghanima, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ostfold Hospital Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria First randomization (Induction phase):
1. Male or female aged =18 years.
2. 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.
3. Scheduled intravenous treatment of rituximab.
4. Signed and dated written informed consent.
5. 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):
1. Completion of the induction phase (phase 1) of the study.
2. Sustained response at the end of phase 1.
3. Randomization within 4 weeks after the completion of phase 1, i.e. between week 24 and
28.
Exclusion Criteria first randomization (Induction phase):
1. Previous treatment for ITP with: rituximab, other immune suppressants (including
mycophenolate mofetil, aziothioprin, cyclosporine), chemotherapy or splenectomy.
2. Pregnancy or lactation.
3. Known active gastro-duodenal ulcer.
4. 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.
5. Concomitant autoimmune hemolytic anemia.
6. 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.
7. Active hepatitis B virus or patients with positive HBsAG or HBcAB.
8. 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.
9. Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or
any of the ingredients.
10. Patients in a severely immune compromised state.
11. Known contraindication to a treatment with any proton-pump inhibitor.
12. Active malignancy or history of malignant disease during the last 2 years except cured
skin cancer.
13. 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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Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Purpura, Thrombocytopenic, Idiopathic
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Intervention(s)
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Drug: Rituximab
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Drug: Dexamethasone
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Primary Outcome(s)
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Sustained of overall response
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Improvement at overall response rate in week 24
[Time Frame: Week 24 (+/- 2 weeks)]
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Sustained Complete Response (CR) during maintenance phase
[Time Frame: 52 weeks]
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Complete Response during induction phase
[Time Frame: 24 weeks (+/- 2 weeks)]
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Rescue medication or other elevating platelet therapy
[Time Frame: after 12 weeks in induction phase and 40 weeks in maintenance phase]
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Grade of bleeding during the study (during both phases)
[Time Frame: 24 weeks and 52 weeks]
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Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases)
[Time Frame: 24 weeks and 52 weeks]
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Health related quality of life
[Time Frame: First phase at 24 weeks and second phase at 52 weeks]
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Platelet count Levels > 50 x 109/L during maintenance phase
[Time Frame: phase 2 (52 weeks)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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