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High Grade Myelodysplastic Syndrome LesionsPhase 1/2NCT01305135

Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

A Phase 1/2 study testing azacitidine and idarubicin in people with High Grade Myelodysplastic Syndrome Lesions, run by Groupe Francophone des Myelodysplasies at 32 sites in 2 countries.

Completed

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

Official record

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Trial summary

Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing. For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
azacitidine and idarubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
32 sitesin 2 countries
Study dates
30 Dec 2010to 9 May 2016
Phase
Phase 1/2

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

  • Documented diagnosis of MDS, or CMML with WBC < 13,000/mm3 that meets IPSS criteria for intermediate-2 or high-risk disease,
  • IPSS score ≥1.5
  • Myocardial function do not contraindicate the use of idarubicin
  • Age ≥ 18 years
  • Performance Status ≤2 according to ECOG.
  • Serum creatinine < 1.5 x ULN and normal levels of electrolytes (serum sodium 136-145 mmol/l, Potassium 3,5-4,5 mmol/l, alkaline Reserve 23-29 mmol/l, , Calcium 2,15-2,5 mmol/l, Phosphore 0,87-1,45 mmol/l) Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) < 1.5 x upper limit of normal (ULN)
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  • Serum total bilirubin < 1.5 x ULN.
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Signed informed consent.
  • Female subjects of childbearing potential must:
  • Accept effective contraception without interruption throughout the duration of study and up to three months after the end of treatment.
  • Male subjects must
  • Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy and up to three months after the final treatment if their partner is of childbearing potential and has no contraception.
  • Agree to learn the procedures for preservation of sperm

Who cannot join

  • Uncontrolled infection
  • Prior therapy with anthracycline for MDS.
  • Eligible for an allogeneic stem cell transplantation.
  • Prior therapy with demethylating agents within the last 3 months
  • Prior therapy with Hematopoietic growth factor (ESA or G-CSF) agents or cytotoxic agents (oral chemotherapy, low doses AraC) within the last 30 days.
  • Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast)
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  • Pregnant or lactating females
  • Known HIV-1 positivity
  • Contra-indication to Anthracyclines

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

France31 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49033

  • Hôpital de la cote basque

    Bayonne, 64100

  • Hôpital Avicenne

    Bobigny, 93009

  • CHRU de Caen - Hôpital Côte de Nacre

    Caen, 14033

  • CHU Estaing

    Clermont-Ferrand, 63000

  • CHU Dijon Hôpital d'enfants

    Dijon, 21000

  • CHU Albert Michallon

    Grenoble, 38043

  • CH Le Mans

    Le Mans, 72000

  • CHU de Limoges

    Limoges, 87042

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Institut Paoli-Calmette

    Marseille, 13009

  • CHU Brabois

    Nancy, 54511

  • CHU Hotel dieu

    Nantes, 44093

  • CHU NICE, Hôpital l'Archet

    Nice, 06202

  • Hôpital saint louis - Hématologie Clinique

    Paris, 75010

  • Hôpital Saint Louis - Hématologie Séniors

    Paris, 75010

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital cochin

    Paris, 75014

  • CH de Périgueux

    Périgueux, 24019

  • Centre hospitalier Joffre

    Perpignan, 66046

  • CHU de Haut-Lévèque

    Pessac, Bordeaux - Pessac, 33604

  • CHU de Poitiers

    Poitiers, 86021

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital Hautepierre

    Strasbourg, 67098

  • Hôpital PURPAN - Hématologie Clinique

    Toulouse, 31059

  • Hôpital Purpan - Médecine Interne

    Toulouse, 31059

  • Hôpital Bretonneau

    Tours, 37000

  • CH de Valence

    Valence, 26953

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Tunisia1 site

  • Hôpital Aziza Othmana

    Tunis

Other trials in Tunisia

About this study

Official title: A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing.

For the Phase I study :

Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS.

For the phase II study:

Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS

Read the detailed description

Patients will receive ldarubicin combined to Azacitidine.

  • The first 10 patients will receive Idarubicin 5 mg/m2/d on day 8 of each cycle of Azacitidine 75 mg/m2/d CI during 7 days (First Cohort ).
  • Progression or not to the next cohort of 10 patients : Idarubicin 10 mgm2/d on day 8 of each cycle of Azacitidine 75 mg/m2/d CI during 7 days (Second cohort of 10 patients), will be decided after completion of the first cohort, after review of hematological toxicity by an independent safety review committee (SRC).
  • The next 21 patients will be treated either according to the first or second cohort schedule of Idarubicin, after review of hematological toxicity and efficacy by an independent safety review committee (SRC).
Being tested
azacitidine and idarubicin
Keywords
myelodysplastic syndrome, azacitidine, idarubicin
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • azacitidine and idarubicinDrug

    azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8

Study groups in NCT01305135
Study groupRoleWhat they receive
azacitidine 75mg/m²/d + idarubicin 5mg/m²/dExperimentalphase I : palier 1 have 10 patients and palier 2 have to 10 patients. palier 1: Ida 5mg/m²/d (D8) + AZACITIDINE 75mg/m²/d (D1-D7)
Receives: Drug: azacitidine and idarubicin
Azacitidine 75mg/m²/d + idarubicin 10mg/m²/dExperimentalpalier 2: Ida 10mg/m²/d (D8)+ Azacitidine 75mg/m²/d (D1-D7)
Receives: Drug: azacitidine and idarubicin

What is being measured

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

  1. To determined tolerance and dose limiting toxicities to idarubicin and azacitidine association.

    Measured: After 12 weeks treatment

Secondary outcomes (1)

  1. to determined overall response rate and response duration

    Measured: After six months

Timeline

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

  1. First posted28 Feb 2011 (estimated)
  2. Study start30 Dec 2010
  3. Primary completionJun 2011
  4. Study completion9 May 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01305135
Sponsor's protocol ID
GFM-AZA-IDA-09
Status last verified
Jun 2017
First submitted
25 Feb 2011
Last updated
7 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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