Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999413
Other study ID # FAMYLY
Secondary ID
Status Completed
Phase Phase 2
First received November 15, 2013
Last updated April 26, 2018
Start date November 2013
Est. completion date April 2018

Study information

Verified date April 2018
Source French Innovative Leukemia Organisation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.


Description:

Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2018
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 61 Years
Eligibility Inclusion Criteria:

- Patient between 18 and 60 years old (less than 61 years old)

- With newly diagnosed with AML according to WHO classification:

- With 20% or more blasts in the bone marrow

- Patients with history of tumors other than myeloproliferative disorders or myelodysplastic syndromes, having received chemotherapy and/or radiotherapy without previous history of myelodysplastic syndromes are eligible for the present study

- High-risk cytogenetics defined as one the following abnormalities : 5/5q-, 7/7q-, t(6,9), 11q23 abnormality excluding t(9;11), 3q abnormality,complex karyotype (>3 abnormalites)

- Left ventricular ejection fraction (LVEF) > 50% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan.

- Adequate liver function (all of the following) except if secondary to the leukemia:

Total bilirubin below 1.5 x upper limit of normal (ULN), AST and ALT below 2.5 x ULN , gamma-GT below 2.5 x ULN,

- Adequate kidney function (all of the following): Serum creatinine below 1.5 x ULN, Creatinine clearance above 50 mL/min (Cockroft and Gault formula)

- ECOG performance status < or = 2.

- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient.

- Affiliated to the French Social Security (Health Insurance).

Exclusion Criteria:

- Previous allogeneic stem cell transplantation.

- Pre-existing aplastic anemia

- Presence of favourable cytogenetics with t(8;21), t(15;17), or inv(16)

- Previous history of MDS or myeloproliferative neoplasm

- Uncontrolled active infection.

- History of arrythmia.

- Cardiac toxicity induced by another anthracycline administration

- Maximum cumulative dose reached for any anthracyclin

- Allergy to cytarabine, daunorubicin, fish or egg proteins10. Significant neurologic (grade > 2) or psychiatric disorder, dementia or seizures.

- Clinical symptoms suggesting active central nervous system leukemia.

- Degenerative or toxic encephalopathy

- Severe complications of leukemia such as:Uncontrolled bleeding, Pneumonia with hypoxia or shock

- Prior total body irradiation > 10 Gy.

- Known active HIV, Hepatitis B or C infection

- Pregnancy or breastfeeding

- Concomitant anti-amarile vaccination (yellow fever)

- Concurrent treatment with any other anti-cancer therapy except Hydroxyurea

Study Design


Intervention

Drug:
OMEGAVEN
AML Study treatment induction phase
Daunorubicin
AML Study treatment induction phase
Cytarabine
AML Study treatment induction phase

Locations

Country Name City State
France Emmanuel GYAN Tours

Sponsors (2)

Lead Sponsor Collaborator
French Innovative Leukemia Organisation Fresenius Kabi

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary response to study treatment Number of patients incomplete response rate after the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the induction of untreated AML 1 month
Secondary Tolerance Number of patients with side effects during and after the admistration of a Fish oil emulsion with daunorubicin and cytarabine chemotherapy for the induction of untreated AML 4 months
Secondary Efficacy on peripheral blasts decrease Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy 1 month
Secondary pharmacokinetics Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT04240002 - A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Completed NCT05488613 - Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Terminated NCT02927938 - Leukemia Stem Cell Detection in Acute Myeloid Leukemia Phase 3
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Recruiting NCT03188874 - Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Completed NCT00071006 - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04079296 - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) Phase 1/Phase 2
Completed NCT04509622 - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML) Phase 3
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Completed NCT02252107 - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1 Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01463410 - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler N/A
Completed NCT01242774 - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML) Phase 1
Terminated NCT02134782 - Yoga Fatigue Study N/A
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Completed NCT03625505 - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04266795 - A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Phase 2

External Links