## Protocol Section
### Identification Module
**NCT ID:** NCT04925479

**Brief Title:** Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

**Official Title:** A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors

#### Organization Study ID Info
**ID:** CABL001I12201
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
#### Secondary ID Infos
**ID:** 2021-001286-20
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2031-11-01

**Type:** ESTIMATED

#### Expanded Access Info
**Has Expanded Access:** True
**Status For NCT ID:** AVAILABLE
#### Last Update Post Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-27

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2021-06-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-18
**Study First Submit QC Date:** 2021-06-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to support development of asciminib in the pediatric population (1 to \<18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

**Detailed Description:** The aim of this study is to support development of asciminib in the pediatric population (1 to \<18 years) with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (PH+ CML-CP) previously treated with one or more Tyrosine kinase inhibitor (TKIs).

The primary objective of this study is to characterize the pharmacokinetic (PK) profile of asciminib in pediatric patients with the goal of identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

The pediatric formulation group will include at least 15 participants in each of the following two age categories: 1 to \<12 years and 12 to \<18 years; leading to at least 30 participants enrolled treated with the pediatric formulation. It will consist of a dose determination part (Part 1) and a cohort expansion (Part 2 BID regimen and Part 3 QD regimen).

In Part 1, 4-6 participants will be enrolled in order to obtain at least 4 participants evaluable for PK (these participants may be from either of the age categories described above). The initial starting dose will be based on body weight and will be administered BID with food.

Once the body weight adjusted dose has been determined in Part 1 of the study, the patients will be enrolled in Part 2 until at least 20 participants, including those who were included in Part 1, have been enrolled (10 per age group) in the pediatric formulation group. Once the interim safety and PK analysis 2 is completed for one of the age groups, the Part 3 QD regimen will open for the respective age group to enroll 10 patients (5 patients by age group).

Due to the fact that the pediatric formulation was in development and was not available, this study started with the recruitment of adolescent patients. These participants aged 14 to \<18 years, weighing at least 40 kg receive the adult formulation at a flat dose of 40 mg BID under fasted conditions.

The total duration of the treatment period of the study will be 5 years (260 weeks). Participants who, according to Investigator's judgement, are benefiting from study treatment will remain on treatment up to the completion of the treatment period (Week 260/5 years). The primary analysis for the BID regimen is planned after all participants in Part 1 and 2 have completed at least 52 weeks of study treatment or discontinued earlier.

The primary analysis for combined regimen (BID+QD) is planned after all participants in Part 1, 2 and 3 have completed at least 52 weeks of study treatment or discontinued earlier.

### Conditions Module

**Conditions:**

- Myeloid Leukemia, Philadelphia Positive

**Keywords:**

- Asciminib

- pediatric patients

- Philadelphia chromosome positive chronic myeloid leukemia in chronic phase

- Ph+ CML-CP

- ABL001

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This arm consists of 2 groups:

* The pediatric formulation group where the dose is based on body weight (1.3mg/kg)
* The adult formulation group where participants will receive a flat dose of 40mg BID

**Intervention Names:**

- Drug: Asciminib Pediatric formulation group

- Drug: Asciminib Adult formulation group

**Label:** Asciminib

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Asciminib

**Description:** Asciminib Pediatric formulation group: Mini-tablets will be supplied as size 0 capsules containing 1 mg mini-tablets, taken orally:

10 mg (10x 1 mg tablets in capsule) 15 mg (15x 1 mg tablets in capsule) 20 mg (20x 1 mg tablets in capsule) 30 mg (30x 1 mg tablets in capsule)

**Name:** Asciminib Pediatric formulation group

**Other Names:**

- ABL001

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Asciminib

**Description:** Asciminib Adult formulation group:

40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally.

**Name:** Asciminib Adult formulation group

**Other Names:**

- ABL001

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

**Measure:** Primary Pharmacokinetic (PK) parameter: AUClast

**Time Frame:** 52 weeks

**Description:** Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

**Measure:** Primary PK parameter: AUCtau

**Time Frame:** 52 weeks

**Description:** Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

**Measure:** Secondary PK parameter: Cmax

**Time Frame:** 52 weeks

**Description:** Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

**Measure:** Secondary PK parameter: Tmax

**Time Frame:** 52 weeks

**Description:** Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).

**Measure:** Secondary PK parameter: Ctrough

**Time Frame:** 52 weeks

#### Secondary Outcomes

**Description:** Complete hematological response will be defined as all of the following present for ≥ 4 weeks:

* WBC count \< 10 x 10\^9/L
* Platelet count \< 450 x 10\^9/L
* Basophils \< 5%
* No blasts and promyelocytes in peripheral blood
* Myelocytes + metamyelocytes \< 5% in peripheral blood
* No evidence of extramedullary disease, including spleen and liver

**Measure:** Hematologic responses

**Time Frame:** 52 weeks

**Description:** To assess pharmacodynamic markers of asciminib's anti-leukemic activity. Molecular response will be assessed by Breakpoint Cluster Region gene-Abelson proto-oncogene (BCR-ABL) 1 level.

**Measure:** Molecular responses

**Time Frame:** 52 weeks

**Description:** To assess acceptability and palatability of the pediatric formulation

**Measure:** Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks

**Time Frame:** after first dose at Week 1 Day 1, 4 weeks, 52 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- Male or female participants: Pediatric formulation group: ≥ 1 and less than 18 years of age at study entry. Adult formulation group: ≥ 14 and less than 18 years of age and body weight of ≥ 40 kg at study entry.

* Participants with Ph+ CML-CP must meet all of the following laboratory values at the screening visit. In the case where bone marrow blast and promyelocyte counts are available, these will be accepted if done within 56 days prior to the screening visit, to avoid unnecessary repetition of this test.

  1. \< 15% blasts in peripheral blood and bone marrow
  2. \< 30% combined blasts plus promyelocytes in peripheral blood and bone marrow
  3. \< 20% basophils in the peripheral blood
  4. Neutrophils ≥ 1.5 x 10\^9/L (or WBC ≥ 3 x 10\^9/L if neutrophils are not available) and platelet count ≥ 100 x 10\^9/L
  5. No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
* Prior treatment with a minimum of one TKI
* Failure (adapted from the 2020 European Leukemia Net (ELN) Guidelines Hochhaus et al 2020 and 2013 ELN Guidelines Baccarani et al 2013) or intolerance to the most recent TKI therapy at the time of screening.
* Performance status: Karnofsky ≥ 50% for patients ≥ 16 years of age, and Lansky ≥ 50 for patients \< 16 years of age at the time of screening
* Participants must have adequate renal, hepatic, pancreatic and cardiac function
* Participants must have electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication:
* Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification.

Exclusion Criteria:

* Known presence of the T315I mutation prior to study entry.
* Known second chronic phase of CML after previous progression to AP/BC.
* Previous treatment with a hematopoietic stem-cell transplantation.
* Patient planning to undergo allogeneic hematopoietic stem cell transplantation.
* Cardiac or cardiac repolarization abnormality
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
* History of acute or chronic liver disease.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
* Pregnant or nursing (lactating) females.

Other protocol-defined inclusion/exclusion may apply.

**Maximum Age:** 18 Years

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** novartis.email@novartis.com

**Name:** Novartis Pharmaceuticals

**Phone:** 1-888-669-6682

**Role:** CONTACT

**Contact 2:**

**Name:** Novartis Pharmaceuticals

**Phone:** +41613241111

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Email:** taylor_sorrentino@dfci.harvard.edu

- **Name:** Taylor Sorrentino

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jessica Pollard

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Dana Farber Cancer Institute Dept.of DFCI

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02215

**Location 2:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Phone:** 212-305-9770

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nobuko Hijiya

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Columbia University Medical Center- New York Presbyterian Herbert Irving Cancer Center

**State:** New York

**Status:** RECRUITING

**Zip:** 10032

**Location 3:**

**City:** Cincinnati

**Contacts:**

***Contact 1:***

- **Email:** jenni.ho@cchmc.org

- **Name:** Jenni Ho

- **Phone:** 800-344-2462

- **Role:** CONTACT

***Contact 2:***

- **Name:** Benjamin Mizukawa

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Cinn Children Hosp Medical Center

**State:** Ohio

**Status:** RECRUITING

**Zip:** 45229-3039

**Location 4:**

**City:** Salt Lake City

**Contacts:**

***Contact 1:***

- **Email:** Keeley.Best@imail2.org

- **Name:** Keeley Best

- **Phone:** 801-213-3599

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mallorie Heneghan

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Utah Primary Childrens Hospital

**State:** Utah

**Status:** RECRUITING

**Zip:** 84132

**Location 5:**

**City:** Hangzhou

**Country:** China

**Facility:** Novartis Investigative Site

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 310005

**Location 6:**

**City:** Beijing

**Country:** China

**Facility:** Novartis Investigative Site

**Status:** RECRUITING

**Zip:** 100044

**Location 7:**

**City:** Shanghai

**Country:** China

**Facility:** Novartis Investigative Site

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**Zip:** 200127

**Location 8:**

**City:** Tianjin

**Country:** China

**Facility:** Novartis Investigative Site

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**Zip:** 300020

**Location 9:**

**City:** Bordeaux Cedex

**Country:** France

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**Zip:** 33076

**Location 10:**

**City:** Lille

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**Location 11:**

**City:** Paris

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**Location 12:**

**City:** Poitiers

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**Zip:** 86021

**Location 13:**

**City:** Erlangen

**Country:** Germany

**Facility:** Novartis Investigative Site

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**Zip:** 91054

**Location 14:**

**City:** Essen

**Country:** Germany

**Facility:** Novartis Investigative Site

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**Zip:** 45147

**Location 15:**

**City:** Hamburg

**Country:** Germany

**Facility:** Novartis Investigative Site

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**Location 16:**

**City:** Athens

**Country:** Greece

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**Zip:** 115 27

**Location 17:**

**City:** Budapest

**Country:** Hungary

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**Location 18:**

**City:** Genova

**Country:** Italy

**Facility:** Novartis Investigative Site

**State:** GE

**Status:** RECRUITING

**Zip:** 16147

**Location 19:**

**City:** Monza

**Country:** Italy

**Facility:** Novartis Investigative Site

**State:** MB

**Status:** RECRUITING

**Zip:** 20900

**Location 20:**

**City:** Torino

**Country:** Italy

**Facility:** Novartis Investigative Site

**State:** TO

**Status:** RECRUITING

**Zip:** 10126

**Location 21:**

**City:** Yokohama-city

**Country:** Japan

**Facility:** Novartis Investigative Site

**State:** Kanagawa

**Status:** RECRUITING

**Zip:** 232-8555

**Location 22:**

**City:** Shinjuku-ku

**Country:** Japan

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**State:** Tokyo

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**Zip:** 160 8582

**Location 23:**

**City:** Osaka

**Country:** Japan

**Facility:** Novartis Investigative Site

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**Zip:** 534-0021

**Location 24:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novartis Investigative Site

**State:** Korea

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**Zip:** 05505

**Location 25:**

**City:** Seoul

**Country:** Korea, Republic of

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**Zip:** 03080

**Location 26:**

**City:** Utrecht

**Country:** Netherlands

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**Location 27:**

**City:** Wrocław

**Country:** Poland

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**Location 28:**

**City:** Moscow

**Country:** Russian Federation

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**Zip:** 117198

**Location 29:**

**City:** Saint Petersburg

**Country:** Russian Federation

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**Location 30:**

**City:** Muang

**Country:** Thailand

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**Location 31:**

**City:** Bangkok

**Country:** Thailand

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**Zip:** 10400

**Location 32:**

**City:** Khon Kaen

**Country:** Thailand

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**Zip:** 40000

**Location 33:**

**City:** Bursa

**Country:** Turkey

**Facility:** Novartis Investigative Site

**State:** Gorukle

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**Zip:** 16059

**Location 34:**

**City:** Istanbul

**Country:** Turkey

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#### Overall Officials

**Official 1:**

**Affiliation:** Novartis Pharmaceuticals

**Name:** Novartis Pharmaceuticals

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

**IPD Sharing:** YES

**URL:** https://www.clinicalstudydatarequest.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000009196

- Term: Myeloproliferative Disorders

- ID: D000001855

- Term: Bone Marrow Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014178

- Term: Translocation, Genetic

- ID: D000002869

- Term: Chromosome Aberrations

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10955

- Name: Leukemia, Myeloid

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: M18123

- Name: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

- Relevance: HIGH

- As Found: Chronic Myeloid Leukemia

- ID: M13582

- Name: Philadelphia Chromosome

- Relevance: HIGH

- As Found: Philadelphia Chromosome

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12149

- Name: Myeloproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5134

- Name: Bone Marrow Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M16932

- Name: Translocation, Genetic

- Relevance: LOW

- As Found: Unknown

- ID: M6109

- Name: Chromosome Aberrations

- Relevance: LOW

- As Found: Unknown

- ID: T3995

- Name: Myeloid Leukemia

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1309

- Name: Chronic Myeloid Leukemia

- Relevance: HIGH

- As Found: Chronic Myeloid Leukemia

- ID: T1311

- Name: Chronic Myeloproliferative Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007951

- Term: Leukemia, Myeloid

- ID: D000015464

- Term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

- ID: D000010677

- Term: Philadelphia Chromosome

### Intervention Browse Module - Ancestors

- ID: D000092004

- Term: Tyrosine Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000014803

- Term: Vitamin B Complex

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: AA

- Name: Amino Acids

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M81032

- Name: Asciminib

- Relevance: HIGH

- As Found: Factorial

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M12476

- Name: Niacinamide

- Relevance: HIGH

- As Found: Factorial

- ID: M12465

- Name: Niacin

- Relevance: LOW

- As Found: Unknown

- ID: M12479

- Name: Nicotinic Acids

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

- ID: T455

- Name: Nicotinamide

- Relevance: LOW

- As Found: Unknown

- ID: T453

- Name: Niacin

- Relevance: LOW

- As Found: Unknown

- ID: T454

- Name: Niacinamide

- Relevance: LOW

- As Found: Unknown

- ID: T456

- Name: Nicotinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T471

- Name: Vitamin B3

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009536

- Term: Niacinamide

- ID: C000621806

- Term: Asciminib

### Misc Info Module

- Version Holder: 2024-05-24
