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

July 2, 2014 updated by: Acute Leukemia French Association

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France
        • Hôpital Avicenne
      • Caen, France, 14033
        • CH
      • Clamart, France, 92141
        • Hôpital Percy
      • Creteil, France, 94010
        • CHU
      • Lille, France, 59037
        • CHU
      • Limoges, France, 87042
        • CH
      • Lyon, France
        • Hôpital Edouard Herriot
      • Meaux, France, 77104
        • CH
      • Paris, France
        • Hôpital Saint-Louis
      • Paris, France, 75012
        • St Antoine Hospital
      • Roubaix, France, 59100
        • CH
      • Rouen, France, 76038
        • CHU
      • Saint-Cloud, France
        • CNLCC
      • Versailles, France
        • CH
      • Villejuif, France, 94805
        • IGR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Gemtuzumab Ozogamicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 45 post first dose of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acute Leukemia French Association

Investigators

  • Principal Investigator: CASTAIGNE SYLVIE, PROFESSOR, Acute Leukemia French Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYLOFRANCE 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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