Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly patients with Acute Myeloid Leukemia

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2012-001594-93-FR
• Date of registration: 10/09/2012
• Prospective Registration: Yes
• Primary sponsor: Innate Pharma
• Public title: Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly patients with Acute Myeloid Leukemia
• Scientific title: 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
• Date of first enrolment: 15/05/2013
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001594-93
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 50
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: Medical Director
• Affiliation: Innate Pharma

• Name: Medical Director
• Affiliation: Innate Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
1) Primary or secondary Acute Myeloid Leukemia in first CR/CRi, 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 10 9/l
• Hemoglobin = 10 g/dl supported or unsupported by transfusions
• ANC > 1 x 10 9/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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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 treatment
6) History of allogeneic hematopoietic cell transplantation or solid organ transplantation
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 Antibody
14) Auto-immune disease:
• Which currently or previously required systemic immunosuppressive or immuno-modulatory therapy (including corticosteroids administered by systemic route)
• 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 years
17) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Acute Myeloid Leukemia in Elderly patients in First Complete Remission
MedDRA version: 15.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Code: IPH2102
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ongoing
CAS Number: 10000676414
Current Sponsor code: IPH2102
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of IPH2102 administered in patients with AML in first complete remission

Primary end point(s): Leukemia-Free Survival calculated from the day of randomization until the occurrence of a relapse, as determined by an Independent Review Committee (IRC), or death from any cause, whichever occurs first.

Secondary Objective: To evaluate the safety of IPH2102

Timepoint(s) of evaluation of this end point: Leukemia-Free Survival calculated from the day of randomization until the occurrence of a relapse, as determined by an Independent Review Committee (IRC), or death from any cause, whichever occurs first.

Secondary Outcome(s)

Secondary end point(s): •Safety
Assessed using the CTCAE version 4.03 of June 14, 2010
•Efficacy
- Time to Relapse (TTR) measured from the day of randomization up to relapse
- Overall Survival (OS)
- Leukemia-Specific Survival (LSS)

Timepoint(s) of evaluation of this end point: Safety: from the time of patient signing the consent form until 28 days after the last administration or until the patient’s last study visit

Efficacy: from the day of randomization until the occurrence of a relapse, or death from any cause, whichever occurs first.

Secondary ID(s)

IPH2102-201

Source(s) of Monetary Support

Innate Pharma