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

Amino Acids

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database)

The study included patients with CML who were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs on third or later lines of therapy in the US.

Tyrosine Kinase Inhibitors (TKIs)

Novartis Pharmaceuticals

Retrospective, non-interventional observational cohort study conducted among patients with CML.

A retrospective, non-interventional cohort study was used to address the study objectives. A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database) to have a better understanding of real-world treatment patterns, HRU and healthcare costs among patients with CML treated with later lines of therapy (i.e., third line or later).

For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental Databases were used (commercial claims). The commercial claims covered the period from 01/01/2001 to 06/30/2019.

The study consisted of the following periods:

* The baseline period was defined as the 6-month period before the first line therapy initiation for CML.
* The observation period was defined as the period of at least 12 months from the first CML diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Study Conducted Among Patients With CML

Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients With Chronic Myeloid Leukemia in Later Lines of Therapy

Number of patients across all lines of therapy were reported to evaluate treatment sequences among the patients.

Number of patients with the use of pre-treatment hydroxyurea were reported to evaluate treatment patterns in patients.

Number of patients Treatment received and initial dose at each line were reported to evaluate treatment patterns in patients.

Number of patients as per the calendar year of line of therapy initiation were reported to evaluate treatment patterns in patients.

Duration of the line of therapy was reported to evaluate treatment patterns in patients.

Treatment-free period among those with an observed subsequent line of therapy was reported to evaluate treatment patterns in patients.

Number of patients who discontinued treatment were reported to evaluate treatment patterns in patients.

Number of patients: All cause Health Resource Utilization were reported to estimate HRU among patients with three lines of therapy or more.

Healthcare costs among patients with three lines of therapy or more were reported.

Prevalence was defined as the number of cases alive per year of patients with CML who were currently or previously treated on later lines of therapy (third line or later), by calendar year from 2006 to 2018

Healthcare costs among patients with earlier lines of therapy were reported.

Number of patients: All cause Health Resource Utilization among patients with earlier lines of therapy were reported.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

Patients with radical nephrectomy are observed without intervention

The investigators randomly assign multimodal recurrence scoring system defined high risk patients of stage III ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation

Jin-huan Wei, MD

Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group. Disease free survival and overall survival are the end points of observation.

Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on Multimodal Recurrence Scoring System

Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.

Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Conducted Among Patients With CML	NCT05476562	Chronic Myeloid...	Tyrosine Kinase...	18 Years - 85 Years	Novartis
Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment	NCT06032728	Renal Cell Carc...	Sunitinib	18 Years - 75 Years	First Affiliated Hospital, Sun Yat-Sen University
Study Conducted Among Patients With CML	NCT05476562	Chronic Myeloid...	Tyrosine Kinase...	18 Years - 85 Years	Novartis

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