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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Mylotarg
Sponsored by
Acute Leukemia French Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, First relapsing AML

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Avicenne
  • CH
  • Hopital Percy
  • CHU
  • CHU
  • CH
  • Hopital Edouard Herriot
  • CH
  • St Antoine Hospital
  • Hopital Saint-Louis
  • CH
  • CHU
  • CNLCC
  • CH
  • IGR

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAUNORUBICINE - ARACYTINE - MYLOTARG -

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2011
Last Updated
July 2, 2014
Sponsor
Acute Leukemia French Association
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1. Study Identification

Unique Protocol Identification Number
NCT02182596
Brief Title
DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML
Acronym
MYLOFRANCE2
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Acute Leukemia French Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, First relapsing AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAUNORUBICINE - ARACYTINE - MYLOTARG -
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mylotarg
Other Intervention Name(s)
Gemtuzumab Ozogamicin
Intervention Description
Dose level study
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CASTAIGNE SYLVIE, PROFESSOR
Organizational Affiliation
Acute Leukemia French Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Avicenne
City
Bobigny
Country
France
Facility Name
CH
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHU
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CH
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
Country
France
Facility Name
CH
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
St Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
Country
France
Facility Name
CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CNLCC
City
Saint-Cloud
Country
France
Facility Name
CH
City
Versailles
Country
France
Facility Name
IGR
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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