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Acute Myeloid LeukemiaPhase 1/2MYLOFRANCE2NCT02182596

DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

A Phase 1/2 study testing Mylotarg in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 15 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

For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Mylotarg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
15 sitesFrance
Study dates
Jun 2006to Jan 2011
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 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a morphologically proven diagnosis of CD33-positive AML and :
  • Age ≥ 50 years and ≤ 70 years.
  • First relapsing AML with a duration of first CR ≥ 3 and ≤18 months
  • ECOG performance status 0 to 3
  • Negative serology HIV, HBV and HBC (except post vaccination)
  • Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N
Show all 9Show fewer
  • Cardiac function determined by radionuclide or echography within normal limits.
  • Negative serum pregnancy test within one week before treatment for women of child bearing potential
  • Signed informed consent.

Who cannot join

  • M3-AML
  • AML following diagnosed myelodysplastic syndrome or myeloproliferation
  • Known central nervous system involvement with AML
  • Prior treatment with HSCT.
  • Previous treatment with Anti CD33 antibodies
  • Uncontrolled infection
  • Other active malignancy

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Hopital Avicenne

    Bobigny

  • CH

    Caen, 14033

  • Hopital Percy

    Clamart, 92141

  • CHU

    Créteil, 94010

  • CHU

    Lille, 59037

  • CH

    Limoges, 87042

  • Hopital Edouard Herriot

    Lyon

  • CH

    Meaux, 77104

  • St Antoine Hospital

    Paris, 75012

  • Hopital Saint-Louis

    Paris

  • CH

    Roubaix, 59100

  • CHU

    Rouen, 76038

  • CNLCC

    Saint-Cloud

  • CH

    Versailles

  • IGR

    Villejuif, 94805

Other trials in France

About this study

Official title: A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia

For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.

Read the detailed description

Induction course are:

GO 3mg/m2 on days 1, 4,7 + the three dose levels were as follows:

level 1: DNR: 45 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 2: DNR: 60 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 3: DNR 60 mg/m2 x 3 days + AraC: 200 mg/m2 x 7 days. with 20 mg of methylprednisolone prior to each GO infusion. Consolidation course: patients in CR may receive 2 additional courses of consolidation chemotherapy with Amsacrine 90 mg/m2 daily for 3 days, and Ara-C (1g/m2/12 hours x 3 days) + GO 3 mg/m2 on day 1.

Treatment with HSCT is offered at the discretion of the physician in charge of the patient. A delay between last infusion of GO and HSCT above 3 months is recommended

Being tested
Mylotarg
Keywords
Acute Myeloid Leukemia, First relapsing AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • MylotargDrug

    Also called Gemtuzumab Ozogamicin

    Dose level study

Study groups in NCT02182596
Study groupRoleWhat they receive
DAUNORUBICINE - ARACYTINE - MYLOTARG -ExperimentalAdaptive Bayesian method for dose-finding in phase I/II clinical trials based on treatment efficacy and toxicity (Thall, Russel, 1998), with successive patients cohorts and three combined dose levels: DNR 45 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 200 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. Two consolidation courses for CR patients: Amsacrine: 90 mg/m2 IV Day 1 Cytarabine: 1g/m2 twice a day IV Days 1 to 4 Mylotarg: 3 mg/m2 IV Day 1.
Receives: Drug: Mylotarg

What is being measured

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

  1. Dose-limiting toxicity (DLT) defined by the occurrence of any G3 or G4 non reversible toxicity at day 45 excluding myelosuppression or infection due to neutropenia, and response defined by complete remission at day 45

    Measured: Day 45 post first dose of treatment

Secondary outcomes (1)

  1. Secondary endpoint: Duration of second remission in AML patients treated for relapse with chemotherapy + Mylotarg as re-induction and consolidation.

    Measured: At two years

Timeline

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

  1. First posted8 Jul 2014 (estimated)
  2. Study startJun 2006
  3. Primary completionSep 2007
  4. Study completionJan 2011

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182596
Sponsor's protocol ID
MYLOFRANCE 2
Acronym
MYLOFRANCE2
Status last verified
Jul 2014
First submitted
19 Jan 2011
Last updated
8 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mylotarg in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 15 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 9 inclusion and 7 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 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?

Dose-limiting toxicity (DLT) defined by the occurrence of any G3 or G4 non reversible toxicity at day 45 excluding myelosuppression or infection due to neutropenia, and response defined by complete remission at day 45 (time frame: Day 45 post first dose 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 NCT02182596.

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 8 Jul 2014.

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