Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura
ITP0207
Randomized Study of the Treatment of Primary Immune Thrombocytopenic Purpura (ITP) in Newly Diagnosed Untreated Adult Patients. Comparison of Standard Dose Prednisone Versus High-dose Dexamethasone.
4 other identifiers
interventional
150
1 country
42
Brief Summary
RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which drug is more effective in treating primary immune thrombocytopenic purpura. PURPOSE: This randomized phase III trial is studying high-dose dexamethasone to see how well it works compared to standard-dose prednisone in treating patients with newly diagnosed, previously untreated primary immune thrombocytopenic purpura.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Longer than P75 for phase_3
42 active sites
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
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 20, 2017
February 1, 2017
7.8 years
April 11, 2008
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Final response (complete, partial, and minimal response) rate from evaluation of initial response
At day +180 from evaluation of initial response
Secondary Outcomes (12)
Initial response rate
At day 42 (arm I), at day 46 (arm II)
Quality of response per arm
At initial evaluation and at final evaluation
Final response rate
At day 180 from the statement of initial response
Rate of bleeding events
At 3 years from study entry
Resumed response rate in non-responder patients (at day 42) or patients who have lost response before day 180 from the first evaluation (arm I only)
At day 42 or before day 180 from the first evaluation
- +7 more secondary outcomes
Study Arms (2)
ARM A - PDN
EXPERIMENTALPDN is administered orally at the daily dose of 1 mg/Kg for 4 consecutive weeks (from day 0 to day 28), then, therapy is tapered within 14 days. The patients considered NOT RESPONDER at day 42 or WHO HAVE LOST THE RESPONSE within the evaluation of final response (see paragraph 8.1), will be crossed to ARM B.
ARM B - DXM
EXPERIMENTALDXM is administered orally at single fixed daily doses of 40 mg for 4 consecutive days, every 14 days, for 3 consecutive courses. If platelet count is £ 20x109/L or bleeding symptoms related to thrombocytopenia are present, lowdose DXM (0.035 mg/Kg/day) between courses is given. The patients (either from ARM A+B or from ARM B) considered NOT RESPONDER at day 46 or who HAVE LOST THE RESPONSE within the evaluation of final response (see paragraph 8.1), will be considered OFF TREATMENT. For these patients a second line therapy will be considered, according to the medical practice of the Centre (splenectomy or other).
Interventions
Eligibility Criteria
You may qualify if:
- Signed written informed consent according to IGH/EU/GCP and national local laws
- Newly diagnosed untreated ITP adult patients
- Age \> 18 \< 80 years
- Platelet count \<20x109/L
- Platelet count \> 20 x109/L and \<50x109/L plus bleeding with score \> 8 (according to grading scale at paragraph 7.1)
- Baseline Quality of Life evaluation questionnaire filled in Newly diagnosed untreated ITP adult patients
- Age \> 18 \< 80 years
- Platelet count \<20x109/L
- Platelet count \> 20 x109/L and \<50x109/L plus bleeding with score \> 8 (according to grading scale at paragraph 7.1)
- Baseline Quality of Life evaluation questionnaire filled in
You may not qualify if:
- Active malignancy at time of study entry
- Steroids administration (PDN \<1mg/Kg/day) for more than 5 days before randomization
- Concomitant treatment with anti-platelet and or anti-coagulant drugs
- Concomitant severe psychiatric disorders
- Not confirmed diagnosis of ITP for
- \*Positivity of autoimmunity markers: antinucleus (≥1:80), anti-tireoglobulin, anti-tireoperoxidase, anti-cardiolipin (≥ 40 GPL UmL), anti-b2glycoprotein (≥ 40 IgG U/mL) antibodies, Lupus Anticoagulant (KCT ratio, dRVVT ratios ≥1.5 times the upper normal limit ), direct antiglobulin test (DAT ).
- Presence of autoimmune hemolytic anemia
- Presence of connective tissue disease
- Women who are pregnant or breastfeeding
- Cardiovascular diseases requiring treatment
- Severe non-controlled, despite therapy, hypertension and diabetes
- Liver and kidney function impairment (creatinine, ALT, AST \>2 times upper normal limit)
- HCVAb, HIVAb, HBsAg, HBcAb seropositive status
- Chronic liver disease
- Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
Tricase, (le), Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda ospedaliera Nuovo Ospedale "Torrette"
Ancona, Italy
USL 8 - Ospedale S.Donato
Arezzo, Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, Italy
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari, Italy
Ospedali Riuniti di Bergamo
Bergamo, 24100, Italy
University of Bologna Medical School
Bologna, 40138, Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125, Italy
Struttura Complessa di Oncologia Medica - Azienda Ospedaliera - Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Italy
Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
Civitanova Marche, Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Cosenza, Italy
Ospedale Maggiore - Div.Medicina Crema
Crema, Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Foggia, Italy
Ospedale Santa Maria Goretti
Latina, 04100, Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, 73100, Italy
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
Meldola, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, Italy
Azienda Ospedaliera San Paolo - Unità di Ematologia e Trombosi
Milan, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza, Italy
Pordenone Unità operativa Medicina II Az. Osp. S. M. degli Angeli
Pordenone, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale "Infermi"
Rimini, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Divisione di Ematologia - Ospedale S. Camillo
Roma, Italy
Divisione Ematologia - Università Campus Bio-Medico
Roma, Italy
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Rome, 00161, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, Italy
Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore
Trieste, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Policlinico G. B. Rossi - Borgo Roma
Verona, 37134, Italy
Ospedale San Bortolo
Vicenza, 36100, Italy
Related Publications (1)
Mazzucconi MG, Rodeghiero F, Avvisati G, De Stefano V, Gugliotta L, Ruggeri M, Vianelli N, Fazi P, Paoloni F, Sargentini V, Baldacci E, Ferretti A, Martino B, Vincelli ID, Carli G, Fortuna S, Di Ianni M, Ranalli P, Palandri F, Polverelli N, Lugli E, Rivolti E, Patriarca A, Rago A, D'Adda M, Gentile M, Siragusa S, Sibilla S, Carella AM, Rossi E, Battistini R, Zaja F, Bocchia M, Di Renzo N, Musto P, Crugnola M, Giuffrida AC, Krampera M, Tafuri A, Santoro C. Prednisone vs high-dose dexamethasone in newly diagnosed adult primary immune thrombocytopenia: a randomized trial. Blood Adv. 2024 Mar 26;8(6):1529-1540. doi: 10.1182/bloodadvances.2023010975.
PMID: 38231017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Gabriella Mazzucconi, MD
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2008
First Posted
April 14, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 20, 2017
Record last verified: 2017-02