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Myelodysplastic SyndromesPhase 2GFM-AZA-REV-09NCT01088373

Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

A Phase 2 study testing Azacitidine combined to Lenalidomide in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 34 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

Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Azacitidine combined to Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
34 sitesFrance
Study dates
25 Mar 2010to 25 Jul 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age > ou = 18 years and < 75 years.
  • must understand and voluntarily sign an informed consent form.
  • patient considered ineligible for intensive chemotherapy due to age, cardiac contraindication to anthracyclines, comorbidities, previous failure of intensive chemotherapy, or patient willing to avoid intensive chemotherapy.
  • must be able to adhere to the study visit schedule and other protocol requirements.
  • prior thalidomide allowed.
  • documented diagnosis of MDS (according to FAB definition, ie. with marrow blasts up to 30%, or CMML with WBC < 13000/mm3 that meets IPSS criteria for intermediate-2 or high-risk disease.
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  • with an associated del 5q[31](the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities.
  • female subjects of childbearing potential must:
  • understand the study drug is expected to have a teratogenic risk.
  • agree to have a medically supervised pregnancy test with a minimum sensitivity of 25mIU/ml 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 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 4 weeks 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 effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy(including doses interruptions)and for 3 months after the end of the study drug therapy even if she has amenorrhea this applies unless the subject commits to absolute and continuous abstinence confirmed on a monthly basis, to avoid pregnancy for the duration of study.
  • the following are effective methods of contraception:
  • implant
  • levonorgestrel-releasing intrauterine system(IUS)
  • Medroxyprogesterone acetate depot, tubal sterilization.
  • sexual intercourse with a vasectomised male partner only(vasectomised must be confirmed by two negative semen analyses), ovulation inhibitory progesterone-only pills(i.e.desogestrel).
  • if not established on effective contraception, the female subject must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
  • Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a female subject is currently using combined oral contraception, the patient should switch to one of the effective methods listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone.
  • Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia .
  • Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
  • 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
  • Male patients must :
  • Agree the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential. during the entire period of treatment, even if disruption of treatment and during 3 months after end of treatment
  • Agree not to conceive during treatment and study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy
  • Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
  • Agree to learn about the procedures for preservation of sperm., before starting treatment
  • All subjects must :
  • Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
  • Agree not to share study medication with another person and to return all unused study drug to the investigator.
  • Signed informed consent prior to start of any study-specific procedures,
  • Ability to participate to a clinical trial and adhere to study procedures.
  • Criteria for women of non-childbearing potential :
  • A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
  • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential)
  • Premature ovarian failure confirmed by a specialist gynaecologist
  • Previous bilateral salpingo-oophorectomy, or hysterectomy
  • XY genotype, Turner syndrome, uterine agenesis.

Who cannot join

None listed.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

France34 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 43033

  • Hôpital de la cote basque

    Bayonne, 64100

  • Hôpital Avicenne

    Bobigny, 93009

  • CHU Haut-Lévèque

    Bordeaux, 33604

  • CH René Dubos

    Cergy-Pontoise, 95303

  • CHU de

    Clermont-Ferrand, 63058

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes, 91106

  • CHU Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • Hôpital kremlin Bicêtre

    Le Kremlin-Bicêtre, IDF, 94275

  • CH Le mans

    Le Mans, 72037

  • Centre Hospitalier de Lens

    Lens, 32307

  • CHRU de Limoges

    Limoges, 87046

  • Hôpital Edouard Heriot, dpt Hématologie Clinique

    Lyon, 69437

  • Institut Paoli-Calmette, Département d'hématologie

    Marseille, 13009

  • Centre Hospitalier de Meaux

    Meaux, 77100

  • Chu Brabois

    Nancy, Vandoeuvre, 54511

  • Hopital de l'Hotel Dieu, Hematology Dpt

    Nantes, 44093

  • CHU Archet

    Nice, 06202

  • CHR La Source orléans

    Orléans, 45067

  • Hôpital Saint Louis

    Paris, 75010

  • Saint-Louis Hospital

    Paris, 75010

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital la pitié-Salpétrière

    Paris, 75013

  • Hopital Cochin Service d'Hématologie

    Paris, 75679

  • Hôpital Maréchal Joffre

    Perpignan, 66046

  • Hôpital Jean-Bernard

    Poitiers, 86021

  • centre hospitalier Jacques Puel

    Rodez, 12027

  • Hôpital Henri Becquerel

    Rouen, 76038

  • Hôpital Purpan, médecine Interne

    Toulouse, 31059

  • Hôpital PURPAN, Service d'Hématologie Clinique

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37044

  • Institut gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007).

Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q.

Read more

In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).

Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose).

For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response.

In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.

Being tested
Azacitidine combined to Lenalidomide
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 combined to LenalidomideDrug

    Also called Vidaza., Revlimid.

    Azacitidine: 75mg/m2/d for 5 days per cycle of 28 days. Lenalidomide: 5mg/day during 14 days for cohort 1. Lenalidomide: 5mg/day during 21 days for cohort 2. Lenalidomide: 10mg/day during 21 days for cohort 3.

Study groups in NCT01088373
Study groupRoleWhat they receive
Azacitidine, LenalidomideExperimentalNot described
Receives: Drug: Azacitidine combined to Lenalidomide

What is being measured

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

  1. To identify the "safe most successful dose"(sMSD) that is the dose level where the probabilities of success is maximized across the dose levels and the toxicity rate is kept within acceptable boundaries.

    Briefly, dose limiting toxicity would be defined by having greater than 30% occurrence of unexpected grade III-IV hematological or non hematological toxicity. Efficacy would be defined as a response rate of 40% after 2 cycles. Overall, 49 patients will be included.

    Measured: 2 and 4 months of treatment

Secondary outcomes (1)

  1. response rate and safety

    1. response rate (according to IWG 2006 criteria) to the combination of lenalidomide and azacitidine in adult high and int 2 MDS with del 5q
    2. safety (particularly hematological toxicity) of the combination of Lenalidomide and azacitidine in int-2 and high risk MDS with del 5q [31].
    3. duration of response,
    4. progression to AML,
    5. and overall survival.

    Measured: 36 months

Timeline

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

  1. First posted17 Mar 2010 (estimated)
  2. Study start25 Mar 2010
  3. Primary completion25 Jul 2016
  4. Study completion25 Jul 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088373
Sponsor's protocol ID
AZA-REV-09
Acronym
GFM-AZA-REV-09
Status last verified
Dec 2017
First submitted
16 Mar 2010
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine combined to Lenalidomide in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 34 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 40 inclusion and 0 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 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 identify the "safe most successful dose"(sMSD) that is the dose level where the probabilities of success is maximized across the dose levels and the toxicity rate is kept within acceptable boundaries. (time frame: 2 and 4 months of treatment). 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 NCT01088373.

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 15 Dec 2017.

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