Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Imatinib Mesylate

Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.

Inecalcitol

Jean-Francois Dufour-Lamartinie, MD

Hyacinthe Johnson- Ansah, MD

To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.

To determine:

* Duration of response
* Progression free survival
* Proportion of responders 2 years after discontinuation of inecalcitol
* Duration of response after discontinuation of inecalcitol and imatinib
* Bone remodelling effect
* Safety of inecalcitol in combination with imatinib
* Quality of Life

Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

Proportion of responder defined as patients achieving MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABLIS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.

Hybrigenics Corporation

Leukemia, Myeloid, Acute

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

Vitamins

Decitabine

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.

Two tablets of placebo 2mg each (total 4mg) taken orally every other day

Placebo Oral Tablet

Shankar Srinivasan, PhD

Marin Xavier, M.D.

Boyka S Petrov

Jeremy M Pantin, M.D.

Christine Sanchez

Khin Win, MBBS, CCRC

Tiffany Gordon

Edwin Kingsley, MD

Kaylee Deutsch, MHA, CCRP

April Encee, RN, OCN

Cecilia Arana-Yi, MD

David Rizzieri, M.D.

Rachel Stowe

Jorge Cortes, M.D.

Jane A Autry

Dawn Minikel

Amelia Crouse

Timothy Wassenaar, MD

Olivier Hermine, MD, PhD

Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study	NCT02949570	CML, Chronic Ph...	Inecalcitol	18 Years -	Hybrigenics Corporation
Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy	NCT02802267	Acute Myelogeno...	Inecalcitol Placebo Oral Ta...	65 Years -	Hybrigenics Corporation

Spots Global Cancer Trial Database for inecalcitol

Every month we try and update this database with for inecalcitol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for inecalcitol

Every month we try and update this database with for inecalcitol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for inecalcitol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.