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Myelodysplastic SyndromesPhase 1/2NCT01324960

Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes

A Phase 1/2 study testing Ceplene®, IL-2, Azacitidine and Azacitidine in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 28 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Ceplene®, IL-2, Azacitidine and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
28 sitesFrance
Study dates
Mar 2011to Dec 2014
Phase
Phase 1/2
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 years
  • Must understand and voluntarily sign an informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria for intermediate-2 or high-risk disease
  • Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of Azacitidine.
  • Patients must have ECOG performance status (PS) of 0 - 2.
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  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
  • Creatinine clearance >50 ml/min
  • Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) < 3.0 x upper limit of normal (ULN)
  • Serum total bilirubin < 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to Gilbert's disease or secondary to MDS).

Who cannot join

  • Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
  • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy
  • Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
  • Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years
  • Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease
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  • History of seizures, central nervous disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the investigator
  • Prior history of autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis)
  • Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history of bleeding
  • Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents Patients with a history of hypersensitivity to histamine or histamine products, severe allergies to food or contrast media requiring treatment within the last five years.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 43033

  • CH d'Avignon

    Avignon, 84000

  • Hôpital de la Côte Basque

    Bayonne, 64100

  • Hopital Avicenne

    Bobigny, 93009

  • CHU de Caen

    Caen, 14033

  • CHU de

    Clermont-Ferrand, 63058

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes, 91106

  • CHU Grenoble

    Grenoble, 38043

  • Hôpital Versailles

    Le Chesnay, 78157

  • CHU de Bicêtre

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

  • Hôpital Saint Vincent

    Lille, 59020

  • CHRU Hurriez

    Lille, 59057

  • CHRU Limoges

    Limoges, 87046

  • Hôpital Edouard Heriot, dpt Hématologie Clinique

    Lyon, 69437

  • Hôpital Paoli-Calmettes

    Marseille, 13273

  • Hematology Dpt, Hopital de l'Hotel Dieu

    Nantes, 44093

  • CHU Archet

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75475

  • Hôpital Saint Antoine

    Paris, 75571

  • CHU Cochin

    Paris, Île-de-France Region, 75679

  • Centre Hospitalier Joffre

    Perpignan, 66046

  • Hôpital Jean-Bernard

    Poitiers, 86021

  • CHRU de Reims

    Reims, 51092

  • Centre Henri Bequerel

    Rouen, 76038

  • Centre Hospitalier Universitaire de STRASBOURG

    Strasbourg, 67098

  • Hopital Purpan Service d'Hématologie Clinique

    Toulouse

  • Hopital Bretonneau

    Tours, 37044

Other trials in France

About this study

Official title: A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine

A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.

Being tested
Ceplene®, IL-2, Azacitidine, Azacitidine
Keywords
IPSS, High risk, Azacitidine, Ceplene
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • Ceplene®, IL-2, AzacitidineDrug

    Also called Human recombinant IL-2 = Aldesleukin® (Novartis), Azacitidine = Vidaza® (Celgene)

    Azacitidine: 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene at 0.5 mg subcutaneous twice daily and human recombinant IL-2 at 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.

  • AzacitidineDrug

    Also called Azacitidine = Vidaza® (Celgene)

    Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks

Study groups in NCT01324960
Study groupRoleWhat they receive
Ceplene® / IL2 + AzacitidineExperimentalAzacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene (EpiCept Corporation, Tarrytown, NY) at 0.5 mg subcutaneous twice daily and human recombinant IL-2 (aldesleukin; Novartis) 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.
Receives: Drug: Ceplene®, IL-2, Azacitidine
AzacitidineActive comparatorAzacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks
Receives: Drug: Azacitidine

What is being measured

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

  1. Time to progression according to IWG2006 criteria

    Progression will be assessed by monitoring the bone marrow, blood and hematologic supportive care according IWG 2006 criteria .

    Measured: Every 4 cycles (during average 2 years)

Secondary outcomes (2)

  1. Types and numbers of adverse events occuring in all treated patients

    The safety profile will be determine by assessements of clinical symptoms, physical examinations, vital signs and clinical laboratory tests. The types and numbers of adverse events occuring in all treated patients will be tabulated.

    Measured: Every cycle, during the follow-up on average during 2 years

  2. Improvement of the quality and the duration of responses compared to maintenance with AZA alone

    The response will be assessed every 4 cycles according IWG 2006 criteria and it will be evaluated if there is an improvement of the level of response and the response duration

    Measured: While patient is on study, during follow up on average during 2 years

Timeline

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

  1. First posted29 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01324960
Sponsor's protocol ID
GFM-Aza-ceplene
Status last verified
Mar 2011
First submitted
7 Mar 2011
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ceplene®, IL-2, Azacitidine and Azacitidine in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 28 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 10 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: withdrawn, 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 28 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Time to progression according to IWG2006 criteria (time frame: Every 4 cycles (during average 2 years)). 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 NCT01324960.

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.

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