AzTrials
AzTrials

Nonneoplastic ConditionPhase 3ITP0207NCT00657410

Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura

A Phase 3 study testing dexamethasone, prednisone and quality-of-life assessment in people with Nonneoplastic Condition, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 42 sites in Italy.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Nonneoplastic Condition
What is being tested?
dexamethasone, prednisone and quality-of-life assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
42 sitesItaly
Study dates
Apr 2008to Feb 2016
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 ).
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  • 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
  • Intake of drugs not previously taken within one week before diagnosis
  • Bleeding score 15 due to ICH or to GI bleeding (according to grading scale at paragraph 7.1, Tab. 3)
  • Active gastric ulcer.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

Italy42 sites

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Azienda ospedaliera Nuovo Ospedale "Torrette"

    Ancona

  • USL 8 - Ospedale S.Donato

    Arezzo

  • Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"

    Ascoli Piceno

  • UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

    Bari

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • University of Bologna Medical School

    Bologna, 40138

  • Sezione di Ematologia e Trapianti Spedali Civili

    Brescia, 21125

  • Struttura Complessa di Oncologia Medica - Azienda Ospedaliera - Ospedale di Circolo di Busto Arsizio

    Busto Arsizio

  • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

    Civitanova Marche

  • U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza

    Cosenza

  • Ospedale Maggiore - Div.Medicina Crema

    Crema

  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

    Foggia

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia

    Lecce, 73100

  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

    Meldola

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

    Messina

  • Azienda Ospedaliera San Paolo - Unità di Ematologia e Trombosi

    Milan

  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

    Pavia, 27100

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

    Piacenza

  • Pordenone Unità operativa Medicina II Az. Osp. S. M. degli Angeli

    Pordenone

  • Dipartimento Oncologico - Ospedale S.Maria delle Croci

    Ravenna

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale "Infermi"

    Rimini

  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

    Roma

  • Divisione di Ematologia - Ospedale S. Camillo

    Roma

  • Divisione Ematologia - Università Campus Bio-Medico

    Roma

  • UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

    Siena

  • Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"

    Torino

  • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico

    Tricase, (le)

  • Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore

    Trieste

  • Clinica Ematologica - Policlinico Universitario

    Udine

  • Policlinico G. B. Rossi - Borgo Roma

    Verona, 37134

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

About this study

Official title: 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.

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.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the role of therapy intensification in adult patients with newly diagnosed, previously untreated primary immune thrombocytopenic purpura with high-dose dexamethasone (HD-DXM), in terms of improvement of response at 6 months after initial response, in comparison with standard-doses of prednisone.

Secondary

  • Compare rate of initial response.
  • Compare quality of response.
  • Compare rate of final responses and rate of persistent response.
  • Compare rate of bleeding events.
  • Determine rate of resumed response with HD-DXM in non-responder patients or patients who have lost response (arm I only).
  • Compare time to platelet number increase until a hemostatically effective level is reached and/or disappearance of bleeding symptoms.
  • Compare rate of rescue interventions.
  • Compare rate of eligible patients for splenectomy.
  • Compare rate of patients who underwent splenectomy.
  • Compare rate of patients who develop connective tissue diseases or underlying hematological diseases (myelodysplastic syndromes, chronic lymphoproliferative diseases, others).
  • Compare patient's self reported quality of life.

OUTLINE: This is a multicenter study. Patients are stratified by treating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (Standard-dose prednisone): Patients receive oral prednisone at a standard dose (1 mg/Kg) once daily on days 1-28 followed by a 14-day taper.

Patients considered non-responders at day 42 or who have lost response before evaluation of final response (day 180) are crossed to arm II.

  • Arm II (High-dose dexamethasone): Patients receive oral dexamethasone at a high dose (40 mg/day) once daily on days 1-4. Treatment repeats every 14 days for 3 courses.

Quality of life is assessed at baseline, on day 42 (arm I) or 46 (arm II) (initial response evaluation day), 180 days after initial response evaluation, and at 3, 9, 12 months after randomization.

After completion of study treatment, patients are followed monthly until 1 year after randomization, every 2 months for 1 year, and then every 3 months for 1 year.

Being tested
dexamethasone, prednisone, quality-of-life assessment
Keywords
idiopathic thrombocytopenic purpura
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.

Study groups in NCT00657410
Study groupRoleWhat they receive
ARM A - PDNExperimentalPDN 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.
Receives: Drug: prednisone; Procedure: quality-of-life assessment
ARM B - DXMExperimentalDXM 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).
Receives: Drug: dexamethasone; Procedure: quality-of-life assessment

What is being measured

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

  1. Final response (complete, partial, and minimal response) rate from evaluation of initial response

    Measured: At day +180 from evaluation of initial response

Secondary outcomes (12)

  1. Initial response rate

    Measured: At day 42 (arm I), at day 46 (arm II)

  2. Quality of response per arm

    Measured: At initial evaluation and at final evaluation

  3. Final response rate

    Measured: At day 180 from the statement of initial response

  4. Rate of bleeding events

    Measured: At 3 years from study entry

  5. 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)

    Measured: At day 42 or before day 180 from the first evaluation

  6. Time to platelet number increase until a hemostatically effective level is reached and/or disappearance of bleeding symptoms

    Measured: At 3 years from study entry

  7. Rate of persistent response

    Measured: At 12 months from the statement of initial response

  8. Association of type of initial response with final and persistent response (in patients with final and persistent response)

    Measured: At 3 years from study entry

  9. Rate of rescue interventions

    Measured: After day 180 from evaluation of initial response

  10. Rate of splenectomy eligible patients

    Measured: At 12 months from enrollment

  11. Rate of patients who have undergone splenectomy during follow-up

    Measured: At 3 years from study entry

  12. Rate of patients who develop connective tissue diseases or underlying hematological diseases (myelodysplastic syndromes, chronic lymphoproliferative diseases, others) during follow-up

    Measured: At 3 years from study entry

Timeline

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

  1. First posted14 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657410
Sponsor's protocol ID
ITP0207
Other IDs
GIMEMA-ITP-0207, Eudract 2008-000417-30, EU-20839
Acronym
ITP0207
Status last verified
Feb 2017
First submitted
11 Apr 2008
Last updated
20 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38231017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dexamethasone, prednisone and quality-of-life assessment in people with Nonneoplastic Condition, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 42 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 10 inclusion and 18 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 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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?

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?

Final response (complete, partial, and minimal response) rate from evaluation of initial response (time frame: At day +180 from evaluation of initial response). 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 NCT00657410, 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 20 Feb 2017.

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