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

patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) who initiated 3L for CML-CP

Novartis Pharmaceuticals

The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.

This study included two distinct cohorts of CML-CP patients; that is, patients with CML-CP who initiated 3L for CML-CP (i.e., 3L cohort) and patients with CML-CP with T315I mutation (i.e., T315I cohort).

Study design for the analyses of the 3L cohort:

* The index date: date of initiation of 3L therapy for CML-CP
* The study period: period of ≥ 24 months following the index date unless the patient died before
* Patient characteristics were measured at CML diagnosis and at the index date
* The clinical outcomes of interest were measured during the study period

Study design for the analyses of the T315I cohort:

* The index date: date of initiation of a line of therapy identified as the T315I line of interest (i.e., identification of T315I mutation before initiation or over the course of line of therapy)
* The study period: period of ≥ 24 months following the index date unless the patient died before
* Patient characteristics were measured at CML diagnosis and at the index date.
* The clinical outcomes of interest were measured during the study period

Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation

Assessing Real-world Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation in the United States (ARC Study)

To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

To evaluate the effectiveness of TKIs and other CML treatments used in 3L+ settings in patients with CML-CP

To evaluate the effectiveness of TKIs and other treatments used in a line of therapy identified as the T315I line of interest in patients with CML-CP

To evaluate treatment patterns in patients with CML-CP with T315I mutation

To evaluate real-world BCR-ABL testing frequency per the latest National Comprehensive Cancer Network (NCCN) guidelines in 3L settings in patients with CML-CP

To evaluate real-world BCR-ABL testing frequency per the latest NCCN guidelines in patients with CML-CP with T315I mutation

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Amino Acids

Midazolam

Nilotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Tasigna

This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following extension study does evaluate the safety of nilotinib.

To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib

An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor

Philadelphia Chromosome

Antineoplastic Agents

Imatinib Mesylate

This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

MMR is defined as BCR-ABL ratio (%) on IS \<= 0.1% (corresponds to \>=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method

Estimated median time to first MMR by Kaplan-Meier method

Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375

Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.

\* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.

Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375

OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.

PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.

Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.

Age, Categorical

Age, Continuous

Sex: Female, Male

Newly diagnosed CML-CP patients not previously treated with imatinib and diagnosed within 6 months of study entry, except for hydroxyurea, and/or anagrelide . In emergent cases where the patient requires disease management Gleevec/Glivec at any dose may be prescribed to the patient for no longer than 2 weeks in duration

Clinical Disclosure Office

The Percentage of Patients Achieving MMR by 12 Months

Time to Molecular Response at 24 Months

K-M Estimate for 3 Month Duration

K-M Estimate for 6 Month Duration

K-M Estimate for 9 Month Duration

K-M Estimate for 12 Month Duration

K-M Estimate for 15 Month Duration

18 months

K-M Estimate for 21 Month Duration

K-M Estimate for 24 Month Duration

Full Analysis set, Number of events / censored 29/312.

Duration of Major Molecular Response

Complete Cytogenetic Response

6 mos after the first CCyR was achieved

12 mos after the first CCyR was achieved

18 mos after the first CCyR was achieved

24 mos after the first CCyR was achieved

Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation	NCT05611216	Chronic Myeloid...		18 Years -	Novartis
To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib	NCT01223898	Chronic Myeloid...	Tasigna	18 Years -	Novartis
Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation	NCT05611216	Chronic Myeloid...		18 Years -	Novartis
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients	NCT01254188	Chronic Myeloid...	Nilotinib	18 Years -	Novartis

Spots Global Cancer Trial Database for cml,

Every month we try and update this database with for cml, 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 cml,

Every month we try and update this database with for cml, 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 cml, 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.