AzTrials
AzTrials

Chronic Myelomonocytic LeukemiaPhase 2NCT01098084

Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

A Phase 2 study testing Decitabine in people with Chronic Myelomonocytic Leukemia, run by Groupe Francophone des Myelodysplasies at 31 sites in France.

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

The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myelomonocytic Leukemia
What is being tested?
Decitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
31 sitesFrance
Study dates
Nov 2008to Jun 2009
Phase
Phase 2
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

  • Age 18 or older
  • CMML diagnosis according to WHO criteria
  • Stable excess in blood monocytes,>1x10G/l and >10% of WBC
  • Bone marrow blasts <20%
  • Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation
  • With:
Show all 19Show fewer
  • if WBC < or= 12 000/mm3: IPSS high or intermediate 2
  • if WBC > 12 000/mm3: at least two of the following criteria: blast cells > 5% in the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13), anemia (Hb < 100 g/l), thrombocytopenia (platelet count < 100G/l), splenomegaly > 5 cm below costal margin, extramedullary localization
  • Either untreated or previously treated with
  • Hydrea or Etoposide given orally
  • non intensive chemotherapy
  • intensive chemotherapy given more than 3 months before inclusion
  • With performance status 0-2 on the ECOG scale
  • With estimated life expectancy of at least 12 weeks
  • With adequate organ function including the following:
  • Hepatic: total bilirubin < 1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
  • Renal: serum creatinine < 1.5 times ULN, creatinine clearance > 30 ml/min
  • With informed consent
  • Negative pregnancy and adequate contraception if relevant

Who cannot join

  • Myeloproliferative/myelodysplastic syndrome other than CMML
  • Acute blastic transformation of CMML with bone marrow blasts>20%
  • Patients eligible for allogenic bone marrow transplantation with identified donor
  • CMML with t(5;12) or PDGFbetaR rearrangement that could receive Imatinib
  • Previous treatment with a hypomethylating agent
  • Age < 18 years old
Show all 10Show fewer
  • Pregnancy or breastfeeding
  • Performance status> 2 on the ECOG Scale
  • Estimated life expectancy < 12 weeks
  • Serious concomitant systemic disorder, 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • CHU d'Amiens

    Amiens, 80054

  • CH Angers

    Angers, 49 000

  • Hôpital Avignon

    Avignon, 84000

  • Hopital de la Cote Basque

    Bayonne, 64100

  • Hôpital Avicenne

    Bobigny, 93009

  • CHU Haut-Lévèque

    Bordeaux, 33604

  • Hôpital Boulogne Sur Mer

    Boulogne-sur-Mer, 62321

  • Hopital d'Instruction des Armées Percy

    Clamart, 92140

  • CHU de

    Clermont-Ferrand, 63058

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes, 91106

  • Hopital Henri Mondor

    Créteil, 94000

  • CHU de Dijon

    Dijon, 21034

  • Hôpital Versailles

    Le Chesnay, 78157

  • CHU de Bicêtre

    Le Kremlin-Bicêtre, Île-de-France Region, 94275

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Institut Paoli Calmettes

    Marseille, 13009

  • CHU de nantes

    Nantes, 44093

  • Hôpital Archet1

    Nice, 06202

  • CHU Caremeau

    Nîmes, 30029

  • CHR La Source orléans

    Orléans, Orléans, 45067

  • Hopital Cochin

    Paris, 75014

  • Hopital Necker

    Paris, 75015

  • Hopital Hotel Dieu

    Paris, 75181

  • Hoiptal St Louis

    Paris, 75475

  • Hôpital Saint-Antoine.

    Paris, 75571

  • Centre Hospitalier Joffre

    Perpignan, 66046

  • CHU de Reims

    Reims, 51092

  • Centre Henri Becquerel

    Rouen, 76038

  • Hematology Dpt, Hopital Purpan

    Toulouse, 40031

  • CHU Bretoneau

    Tours, 37044

  • Institut gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.

Being tested
Decitabine
Keywords
Decitabine, chronic myelomonocytic leukemia
Medical subject headings
Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    20mg/m2/day, one hour intravenous infusion, every day during 5 days

Study groups in NCT01098084
Study groupRoleWhat they receive
DecitabineExperimentalNot described
Receives: Drug: Decitabine

What is being measured

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

  1. To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3

Secondary outcomes (4)

  1. Response duration

  2. Time to progression to AML

  3. Survival

  4. Toxicity (hematological and non-hematological)

Timeline

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

  1. First posted2 Apr 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

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 2
Allocation
Not applicable
Intervention model
Single group
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098084
Sponsor's protocol ID
GFM-DEC-LMMC-2007
Status last verified
Mar 2011
First submitted
1 Apr 2010
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Itzykson R, Kosmider O, Renneville A, Gelsi-Boyer V, Meggendorfer M, Morabito M, Berthon C, Ades L, Fenaux P, Beyne-Rauzy O, Vey N, Braun T, Haferlach T, Dreyfus F, Cross NC, Preudhomme C, Bernard OA, Fontenay M, Vainchenker W, Schnittger S, Birnbaum D, Droin N, Solary E. Prognostic score including gene mutations in chronic myelomonocytic leukemia. J Clin Oncol. 2013 Jul 1;31(19):2428-36. doi: 10.1200/JCO.2012.47.3314. Epub 2013 May 20.

    PubMed 23690417

  • Braun T, Itzykson R, Renneville A, de Renzis B, Dreyfus F, Laribi K, Bouabdallah K, Vey N, Toma A, Recher C, Royer B, Joly B, Vekhoff A, Lafon I, Sanhes L, Meurice G, Orear C, Preudhomme C, Gardin C, Ades L, Fontenay M, Fenaux P, Droin N, Solary E; Groupe Francophone des Myelodysplasies. Molecular predictors of response to decitabine in advanced chronic myelomonocytic leukemia: a phase 2 trial. Blood. 2011 Oct 6;118(14):3824-31. doi: 10.1182/blood-2011-05-352039. Epub 2011 Aug 9.

    PubMed 21828134

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine in people with Chronic Myelomonocytic Leukemia, run by Groupe Francophone des Myelodysplasies at 31 sites in France.

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 19 inclusion and 10 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3. 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 NCT01098084, which also lists 2 linked publications.

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 Mar 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in