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MDSPhase 2NCT02197676

A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

A Phase 2 study testing SGI-110 administration in people with MDS, run by Groupe Francophone des Myelodysplasies at 27 sites in France.

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

Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MDS
What is being tested?
SGI-110 administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
27 sitesFrance
Study dates
4 Aug 2014to 23 Apr 2018
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

  • Myelodysplastic syndrome including the following categories of the WHO classification: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes < 13 G/L but > 10% marrow blasts), AML with 20-30% marrow blasts (RAEB-T according to the FAB classification), at screening time.
  • Prior treatment with azacitidine or decitabine for at least 6 courses without response(CR, PR, marrow CR or stable disease with HI according to IWG 2006 criteria) or relapsing after a response. Non responders will be eligible only in the absence of overt progression, ie AML progression (if patients had no AML at onset of azacitidine/decitabine) or doubling of marrow blast percentage between onset of azacitidine/decitabine and screening
  • IPSS score >1 (IPSS: Int-2 or High).
  • Age ≥ 18 years.
  • Normal liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.
  • Normal renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 50 mL/min.
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  • Patient is known not to be refractory to platelet transfusions.
  • Written informed consent.
  • Patient must understand and voluntarily sign consent form.
  • Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.
  • ECOG performance status between 0-2 at the time of screening.
  • Women of chilbearing potential* must:
  • Understand the study drug is expected to have a teratogenic risk
  • Agree to have a medically supervised pregnancy test on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment.
  • Agree to have a medically supervised pregnancy test every 4 weeks including 2 months after the end of study treatment, except in the case of confirmed tubal sterilization. These pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
  • Agree to use, and to be able to comply with, Two medically acceptable contraceptive measures without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy (including doses interruptions) and for 2 months after the end of the study drug therapy even if she has amenorrhoea. This applies unless the subject commits to absolute and continuous abstinence confirmed on a monthly basis, to avoid pregnancy for the duration of study.
  • Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
  • She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
  • Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 2 3 months after the end of treatment if their partner is of childbearing potential.

Who cannot join

  • Severe infection or any other uncontrolled severe condition.
  • Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.
  • Less than 30 days since prior treatment with growth factors (EPO, G-CSF).
  • Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
  • Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast.
  • Patient already enrolled in another therapeutic trial of an investigational drug.
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  • HIV infection or active hepatitis B or C.
  • Women who are or could become pregnant or who are currently breastfeeding.
  • Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.
  • Patient eligible for allotransplantation.
  • Known allergy to SGI-110 or any of its excipients.
  • No affiliation to an insurance system.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • CH Angers

    Angers, 49 000

  • CH Avignon

    Avignon, 84000

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64100

  • Hôpital Avicenne

    Bobigny, 93 000

  • CHU Clémenceau

    Caen, 14033

  • CHU Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • CHRU Limoges

    Limoges, 87046

  • CH Lyon Sud

    Lyon, 69495

  • Hôpital Paoli Calmettes

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77100

  • Clinique Beausoleil (Montpellier)

    Montpellier, 34000

  • CHU de nantes

    Nantes, 44093

  • Centre Catherine de Sienne (Nantes)

    Nantes, 44277

  • CHU de Nice - Hopital de l'Archet 1

    Nice, 06 202

  • CHR Orléans

    Orléans, 45000

  • Hopital St Louis T4

    Paris, 75475

  • Centre Hospitalier Joffre

    Perpignan, 66046

  • CHU de Haut-Lévèque

    Pessac, 33604

  • CHU de Poitiers

    Poitiers, 86000

  • Centre Hospitalier de la région d'Annecy

    Pringy, 74374

  • Centre Henri Becquerel

    Rouen, 76038

  • Chu Purpan

    Toulouse, 31059

  • Hopital Purpan Service d'Hématologie Clinique

    Toulouse

  • CHU Bretonneau

    Tours, 37044

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.

Read the detailed description

All eligible patients will be treated with SGI-110 for 9 cycles of 28 days.

Patients who meet eligibility criteria will be administered subcutaneous SGI-110 at 60mg/m²/d one time daily for 5 days. Each cycle will last 28 days with SGI-110 starting on day 1 of each cycle. Patients will receive at least 9 cycles unless overt progression is documented. (Overt progression will be defined by the presence of more than 30% marrow blasts and doubling of marrow blast percentage from onset of SGI-110). Dose reduction to 45 and even 30 mg/m²/d will be made in case of toxicity.

Patients with Complete Remission (CR), Partial Remission (PR), marrow CR, Hematological Improvement (HI) or stable disease (SD) after 6 Cycles of therapy (IWG 2006 criteria) may receive 3 additional cycles. Response will be re-evaluated after 9 cycles. Patients with no response (NR) to treatment after 9 cycles will be withdrawn from the protocol. Patients with progression at any time will be withdrawn from the protocol after the last treatment Cycle.

Conditions
MDS
Being tested
SGI-110 administration

What participants receive

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

  • SGI-110 administrationDrug

    SGI-110 will be administered SC at 60 mg/m²/day x5 consecutive days for each cycle. Cycle duration is 28 days. Patients with Complete Remission (CR), Partial Remission (PR), marrow CR or Hematological Improvement (HI) after 6 Cycles of therapy (IWG 2006 criteria) may continue treatment until progression.

    A dose reduction to 45 and even 30 mg/m²/day will be made in case of haematological toxicity. Patients with no response (NR) to treatment will be withdrawn from the protocol after the last treatment Cycle.

Study groups in NCT02197676
Study groupRoleWhat they receive
SGI-110ExperimentalNot described
Receives: Drug: SGI-110 administration

What is being measured

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

  1. Response rate

    Number of complete Remission (CR), CR with incomplete hematological recovery (CRi), Partial Remission (PR), Marrow CR and Hematological Improvement (HI) according to IWG 2006 criteria after 6 treatment cycles

    Measured: 6 month

Secondary outcomes (2)

  1. Duration of response

    Measured from the date an objective response was achieved to the date of relapse or progression (cf. definition in appendix 5) or the date of last contact if no event occurred.

    Measured: 4 years

  2. Adverse event

    Patients must have received at least one dose of treatment in order to be considered evaluable for toxicity.

    Measured: After 1 month

Timeline

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

  1. First posted23 Jul 2014 (estimated)
  2. Study start4 Aug 2014
  3. Primary completion6 Feb 2016
  4. Study completion23 Apr 2018

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02197676
Sponsor's protocol ID
GFM-SGI-110
Status last verified
Dec 2018
First submitted
29 Apr 2014
Last updated
6 Dec 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGI-110 administration in people with MDS, run by Groupe Francophone des Myelodysplasies at 27 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 12 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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?

Response rate (time frame: 6 month). 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 NCT02197676.

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 6 Dec 2018.

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