Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Bosutinib

Nilotinib

Dasatinib

Tyrosine Kinase Inhibitors

Imatinib Mesylate

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Imatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively).

Initial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage.

Imatinib

Initial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage.

Initial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage.

Initial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage.

Anna Turkina, Professor

The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.

The duration of the dose reduction phase will be 12 months. This phase will have two stage of 6 months, respectively.

The dose of imatinib, nilotinib, dasatinib or bosutinib will be reduced by 25-50% on the first stage, and by another 25% on the second stage.

* The initial dose of imatinib will be 400 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.
* The initial dose of nilotinib will be 300 or 400 mg twice daily. The dose will be reduced by 400 mg daily on the first stage, by 200 mg daily - on the second stage.
* The initial dose of dasatinib will be 100 or 140 mg daily. The dose will be reduced by 50 mg daily on the first stage, by 25 mg daily - on the second stage.
* The initial dose of bosutinib will be 500 mg daily. The dose will be reduced by 300 mg daily on the first stage, by 200 mg daily - on the second stage.

All patients with stable deep molecular response (at least 2 years) will be included in treatment free remission phase (TFR-phase). The duration of TFR-phase will be 24 months.

The CML patients can enter the study already on reduced doses TKI, if they will meet the inclusion criteria.

It is possible to include patients, who have already received therapy with reduced doses of TKI. The duration of TKI therapy with reduced doses of 1 stage should be at least 6 months, if TKI doses meet of stage 1. The duration of TKI therapy with reduced doses of 2 stage should be for at least 6 months and the general duration of TKI therapy with reduced doses should be for at least 12 months, if TKI doses meet of stage 2.

A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

Prospective Non-randomized Stratified Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) in Adults With Ph+ Chronic Myeloid Leukemia With Stable Deep Molecular Response

risk group (Sokal, ELTS) at the time of diagnosis

Molecular response at the time of inclusion in the study

National Research Center for Hematology, Russia

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Kidney Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

using tyrosine kinase inhibitors particulary imatinib in ttt CML patients

Biobsy from kidney

sahar mohamed gad, third

Mohamad Ramadan Abd_Elhamied, first

Ahmed Ramadan

Mohamed Ramadan

To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia .

* Chronic myeloid leukemia (CML) is a cancer of bone marrow that leads to an increased number of white blood cells. CML is more prevalent in the elderly and is characterized by weight loss, tiredness, shortness of breath, excessive sweating, bone pain, and frequent infections. \[1\] According to the American Cancer Society's estimates, CML represents 15% of all new leukemia cases.\[2\] The global burden of disease (GBD) study 2015 revealed that leukemia was under the top ten leading causes of death globally.\[3\] However, the latest GBD study found a decrease in the age-standardized incidence rate and the death rate from 1990-2017.\[4\] This dramatic improvement in the overall survival and health-related quality of life among CML patients was attributed to the impact of new therapeutic strategies. Tyrosine kinase inhibitors (TKIs), particularly imatinib, emerged as a potential therapeutic agent for the treatment of CML, reducing epidemiological burden (incidence rate), and improve quality of life.\[5\]
* The definition and classification of chronic kidney disease (CKD) have evolved over time, but current international guidelines define this condition as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause\[6\] Diagnosis is commonly made after chance findings from screening tests (urinary dipstick or blood tests), or when symptoms become severe. The best available indicator of overall kidney function is GFR, which is measured either via exogenous markers (eg, DTPA, iohexol), or estimated using equations. Presence of proteinuria is associated with increased risk of progression of CKD and death. Presence of proteinuria is associated with increased risk of progression of CKD and death.\[7,8\] Kidney biopsy samples can show definitive evidence of CKD, through common changes such as glomerular sclerosis, tubular atrophy, and interstitial fibrosis. Complications include anaemia due to reduced production of erythropoietin by the kidney; reduced red blood cell survival and iron deficiency; and mineral bone disease caused by disturbed vitamin D, calcium, and phosphate metabolism.\[9

Chronic Kidney Disease Patient in Chronic Myloied Leukemia

Using Non Invasive or invasive Methods and correlation between lab and radiological methods to find and a relation between CML and CKD and outcome.

Sahar Mohammed Gad

doctor

Immune System Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Syndrome

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Influenza, Human

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Graft vs Host Disease

Hodgkin Disease

Disease Progression

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Chronic Lymphocytic Leukemia

Homologous Wasting Disease

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Thymoglobulin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

FM-PTCy conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and cyclophosphamide 50 mg/kg on days +3 and +4.

FM-ATG conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and ATG (Thymoglobulin®, Genzyme), at a dose of 2.5 mg/kg/d on days -2 and -1.

ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)

Cyclophosphamid

Frédéric Baron, MD,Ph

Dimitri Breems, MD PhD

Dominik Selleslag, MD, PhD

Philippe Lewalle, MD PhD

Ann De Becker, MD PhD

Rik Schots, MD PhD

Xavier Poiré, MD

Tessa Kerre, MD PhD

Johan Maertens, MD PhD

Hélène Schoemans, MD PhD

Frédéric Baron, MD, PhD

Yves Beguin, MD, PhD

Evelyne Willems, MD

Sophie Servais, MD

Dries Deeren, MD

Carlos Graux, MD PhD

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years.

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)

To assess hematopoietic (whole blood and T cell chimerism) engraftment in the 2 arms.

To assess the quality of immunologic reconstitution in the 2 arms

To assess the timing (days) of immunologic reconstitution in the 2 arms

To assess the incidences of bacterial infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess the incidences of fungal infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess the incidences of viral infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with cGRFS

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with NRM

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with OS

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with Relapse/progression

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with Infections

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with immunologic reconstitution (CD4 and NAIVE T cells counts)

To assess the current GVHD-free, relapse-free survival (cGRFS) for patients in the 2 arms

To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor

To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG

To assess rate of grade II-IV and III-IV acute GVHD (Graft-versus-host disease) in patients conditioned with FM or FM-ATG.

To assess rate of grade of moderate-severe chronic GVHD in patients conditioned with FM or FM-ATG.

To assess rate of Nonrelapse Mortality in patients conditioned with FM-PTCy or FM-ATG.

To assess rate of Leukemia Free Survival in patients conditioned with FM-PTCy or FM-ATG.

To assess rate of Overall Survival in patients conditioned with FM-PTCy or FM-ATG.

To assess the proportion of patients alive without active disease and without systemic immunosuppression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)	NCT04578847	Chronic Myeloid... Chronic Myeloid... BCR-ABL Positiv...	Imatinib Nilotinib Dasatinib Bosutinib	18 Years -	National Research Center for Hematology, Russia
Chronic Kidney Disease Patient in Chronic Myloied Leukemia	NCT06266975	Chronic Myeloid...	Biobsy from kid...	18 Years - 75 Years	Assiut University
Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning	NCT03852407	Acute Myeloid L... Myelodysplastic... Chronic Myeloid... Myeloproliferat... Myeloproliferat... Acute Lymphoid ... Multiple Myelom... Chronic Lymphoi... Non Hodgkin Lym... Hodgkin Lymphom...	Thymoglobulin Melphalan Fludarabine Cyclophosphamid	18 Years - 75 Years	University of Liege

Spots Global Cancer Trial Database for chronic myeloid leukemia in remission