NCT02182596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

January 19, 2011

Last Update Submit

July 2, 2014

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaFirst relapsing AML

Outcome Measures

Primary Outcomes (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

    Day 45 post first dose of treatment

Secondary Outcomes (1)

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

    At two years

Study Arms (1)

DAUNORUBICINE - ARACYTINE - MYLOTARG -

EXPERIMENTAL

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

Interventions

MylotargDRUG

Dose level study

Also known as: Gemtuzumab Ozogamicin
DAUNORUBICINE - ARACYTINE - MYLOTARG -

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hopital Avicenne

Bobigny, France

Location

CH

Caen, 14033, France

Location

Hopital Percy

Clamart, 92141, France

Location

CHU

Créteil, 94010, France

Location

CHU

Lille, 59037, France

Location

CH

Limoges, 87042, France

Location

Hopital Edouard Herriot

Lyon, France

Location

CH

Meaux, 77104, France

Location

St Antoine Hospital

Paris, 75012, France

Location

Hopital Saint-Louis

Paris, France

Location

CH

Roubaix, 59100, France

Location

CHU

Rouen, 76038, France

Location

CNLCC

Saint-Cloud, France

Location

CH

Versailles, France

Location

IGR

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • CASTAIGNE SYLVIE, PROFESSOR

    Acute Leukemia French Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

July 8, 2014

Study Start

June 1, 2006

Primary Completion

September 1, 2007

Study Completion

January 1, 2011

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(15)