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

Acute Myeloid Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182596
• Other study ID #: MYLOFRANCE 2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 19, 2011
• Last updated: July 2, 2014
• Start date: June 2006
• Est. completion date: January 2011

Study information

• Verified date: July 2014
• Source: Acute Leukemia French Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Mylotarg
Dose level study

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	CH	Caen
France	Hopital Percy	Clamart
France	CHU	Creteil
France	CHU	Lille
France	CH	Limoges
France	Hopital Edouard Herriot	Lyon
France	CH	Meaux
France	Hopital Saint-Louis	Paris
France	St Antoine Hospital	Paris
France	CH	Roubaix
France	CHU	Rouen
France	CNLCC	Saint-Cloud
France	CH	Versailles
France	IGR	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Acute Leukemia French Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Secondary endpoint: Duration of second remission in AML patients treated for relapse with chemotherapy + Mylotarg as re-induction and consolidation.		At two years	No