Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia (DECI2009)

June 21, 2018 updated by: Fondazione Italiana Sindromi Mielodisplastiche-ETS

A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

The study aims to assess the activity of decitabine in the treatment of CMML.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy, 60131
        • AOU Ospedali Riuniti di Ancona
      • Bari, Italy, 70124
        • Ematologia AOU Policlinico di Bari
      • Bologna, Italy, 40100
        • Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
      • Brescia, Italy, 25100
        • Ematologia - Spedali Civili
      • Cagliari, Italy, 09121
        • Ematologia- Ospedale Businco
      • Campobasso, Italy, 86100
        • Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
      • Firenze, Italy, 50134
        • Cattedra di Ematologia Policlino Careggi
      • Genova, Italy, 16132
        • Dipartimento Emato-Oncologia AOU San Martino Genova
      • Milano, Italy, 20121
        • Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
      • Monza, Italy, 20052
        • Divisione di Ematologia, Ospedale S.Gerardo di Monza
      • Novara, Italy, 28100
        • Divisione di Ematologia, Università Avogadro
      • Orbassano, Italy, 10043
        • Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Perugia, Italy, 06122
        • Ospedale S.Maria Della Misericordia
      • Pesaro, Italy, 61122
        • AOU San Salvatore
      • Reggio Calabria, Italy, 89125
        • AO Bianchi Melacrino Morelli
      • Rionero in Vulture, Italy, 85028
        • IRCCS Centri di riferimento oncologico
      • Roma, Italy, 00183
        • SC Ematologia AOU S.Andrea
      • Torino, Italy, 10126
        • Ematologia 2-Ospedale S.Giovanni Battista
      • Torino, Italy, 10126
        • U.O.Ematologia 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 18 and older
  2. CMML diagnosis according to WHO criteria

  3. If WBC<=12000/mm3:IPSS High or INT-2

    If WBC>12000/mm3: at least two of the following criteria:

    • Blast cells>5% in the bone marrow
    • Citogenetic abnormality other then t(5;12) (q33;p13)
    • Anemia (Hb<10g/dl)
    • Thrombocytopenia (Plt<100000/mm3)
    • Splenomegaly(>5cm below costal margin)
    • Extramedullary localization
  4. Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
  5. Performance Status ECOG 0,1 or 2
  6. Estimated life expectancy>=6 months

  7. Adequate hepatic function:

    • Total bilirubin < 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis)
    • AST and ALT < 3 times limit of normal

  8. Adequate renal function:

    • Serum creatinine < 1.5 times limit of normal
    • Creatinine clearance > 30ml/min
  9. Informed consent
  10. Negative pregnancy test or adequate contraception methods

Exclusion Criteria:

  1. Myeloproliferative/myelodisplastic syndome othe than CMML
  2. Acute blastic transformation of CMML with bone marrow blast cells>20%
  3. Patients eligible for allogenic bone marrow transplantation with identified donor
  4. CMML with t(5;12) o PDGFBR rearrangement
  5. Intensive chemotherapy given less than 3 months before
  6. Previous treatment with hypomethylating agent
  7. Age< 18 years old
  8. Pregnancy or breastfeeding
  9. Performance Status ECOG>2
  10. Estimate life expectancy<6 months
  11. HIV infection
  12. Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
  13. Serious concomitantsystemic disorders, including active bacterial fungal or viral infection, that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Decitabine
Eligible patients will recieve Dacogen 20mg/m2 in 1 hour iv infusion for 5 days every 28 days (1 cycle)plus Best Supportive Care.A total of 6 courses is planned.
Drug: Decitabine
Decitabine will be administered at a dose of 20 mg/m2 infused over a 1 hour period once daily for 5 consecutive days. The totale amount per course is 100 mg/m2. Cycles will be administered every 4 weeks (1 cycle of 28 days).It is recommented that patients be treated for a minimum of 4 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the activity of decitabine in the treatment of CMML
Time Frame: 24 months
Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
to assess the activity of decitabine in the treatment of CMML in terms of overall survival, time to leukemic transormation, response duration in terms of time to relapse after CR, PR, time to disease progression, ecc
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Sindromi Mielodisplastiche-ETS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Santini Valeria, Professor, U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DECI2009-AISSM06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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