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DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML (MYLOFRANCE2)

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ClinicalTrials.gov Identifier: NCT02182596
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by:
Acute Leukemia French Association

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Mylotarg Phase 1 Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : January 2011


Arm Intervention/treatment
Experimental: DAUNORUBICINE - ARACYTINE - MYLOTARG -

Adaptive 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.

Drug: Mylotarg
Dose level study
Other Name: Gemtuzumab Ozogamicin




Primary Outcome Measures :
  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 [ Time Frame: Day 45 post first dose of treatment ]

Secondary Outcome Measures :
  1. Secondary endpoint: Duration of second remission in AML patients treated for relapse with chemotherapy + Mylotarg as re-induction and consolidation. [ Time Frame: At two years ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with a morphologically proven diagnosis of CD33-positive AML and :

  1. Age ≥ 50 years and ≤ 70 years.
  2. First relapsing AML with a duration of first CR ≥ 3 and ≤18 months
  3. ECOG performance status 0 to 3
  4. Negative serology HIV, HBV and HBC (except post vaccination)
  5. Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N
  6. Cardiac function determined by radionuclide or echography within normal limits.
  7. Negative serum pregnancy test within one week before treatment for women of child bearing potential
  8. Signed informed consent.

Exclusion Criteria:

  1. M3-AML
  2. AML following diagnosed myelodysplastic syndrome or myeloproliferation
  3. Known central nervous system involvement with AML
  4. Prior treatment with HSCT.
  5. Previous treatment with Anti CD33 antibodies
  6. Uncontrolled infection
  7. Other active malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182596


Locations
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France
Hopital Avicenne
Bobigny, France
CH
Caen, France, 14033
Hopital Percy
Clamart, France, 92141
CHU
Creteil, France, 94010
CHU
Lille, France, 59037
CH
Limoges, France, 87042
Hopital Edouard Herriot
Lyon, France
CH
Meaux, France, 77104
St Antoine Hospital
Paris, France, 75012
Hopital Saint-Louis
Paris, France
CH
Roubaix, France, 59100
CHU
Rouen, France, 76038
CNLCC
Saint-Cloud, France
CH
Versailles, France
IGR
Villejuif, France, 94805
Sponsors and Collaborators
Acute Leukemia French Association
Investigators
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Principal Investigator: CASTAIGNE SYLVIE, PROFESSOR Acute Leukemia French Association

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Responsible Party: Pr Sylvie CASTAIGNE, VERSAILLES HOSPITAL
ClinicalTrials.gov Identifier: NCT02182596     History of Changes
Other Study ID Numbers: MYLOFRANCE 2
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by Acute Leukemia French Association:
Acute Myeloid Leukemia
First relapsing AML
Additional relevant MeSH terms:
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Cytarabine
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological