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Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

Phase 2
60 Years
80 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

Inclusion Criteria:

1. Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008
criteria), in first CR/CRi (according to the revised recommendations of the
International Working Group for Diagnosis, Standardization of Response Criteria,
Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid
Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following
induction chemotherapy and who received 1 or 2 consolidation cycles. Induction
chemotherapy should be performed within 6 months before randomization. Consolidation
cycle is defined as any chemotherapy administered within 3 months following CR and
including aracytine irrespective of the administered dose(s). A minimum of one and
maximum of 2 cycles should be administered before enrollment

2. Patients not eligible for an allogeneic hematopoietic cell transplantation

3. Age 60 to 80

4. ECOG Performance status of 0 or 1

5. Clinical laboratory values at screening

- Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2

- Platelet > 75 x 109/l

- Hemoglobin ≥ 10 g/dl supported or unsupported by transfusions

- ANC > 1 x 109/l

- Total Bilirubin levels ≤ 1.5 ULN

- ALT and AST ≤ 3 ULN

6. Recovery from acute toxicity of previous anti-tumor therapy

7. Male patients who accept and are able to use contraception methods recognized as
highly effective.

8. Signed informed consent prior to any protocol specific procedure.

Exclusion Criteria:

1. Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)

2. Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and
their molecular equivalents (AML-ETO and CBFB-MYH11)

3. Last consolidation completed more than 3 months prior to first dosing

4. Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids

5. Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid

6. History of allogeneic hematopoietic cell transplantation or solid organ

7. History of high dose chemotherapy with autologous hematopoietic transplantation
performed as treatment for AML

8. Use of any investigational agent within 2 months prior to the first dosing

9. Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing

10. Any irradiation within the last 3 months except for analgesic intent

11. Intermittent or continuous renal replacement therapy

12. Abnormal cardiac status with any of the following

- Ejection fraction (measured by ultra-sound or radionuclide imaging) <50%

- Myocardial infarction within the previous 6 months

- QTc ≥ 480 ms (Bazett's).

13. Current active infectious disease or positive serology for HIV, and/or HCV with
detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs

14. Auto-immune disease:

- Which currently or previously required systemic immunosuppressive or
immuno-modulatory therapy (including corticosteroids administered by systemic

- And/or has substantial probability to cause an irreversible injury to any tissue

- And/or is recent or unstable or has substantial risk to progress and cause
severe complications.

15. Serious concurrent uncontrolled medical disorder

16. History of another malignancy (apart from myelodysplastic syndromes, basal cell
carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for ≥ 3

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Leukemia-Free Survival

Outcome Time Frame:

from date of randomization until the date of first documented relapse, assessed up to 48 months

Safety Issue:


Principal Investigator

Norbert Vey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli Calmettes Marseille France


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

October 2012

Completion Date:

June 2016

Related Keywords:

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