A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study

2024-516511-24-00 Phase III and Phase IV (Integrated) Ongoing, recruitment ended

Start 14 Nov 2024 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 9 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ongoing, recruitment ended
Participants planned 136
Countries 1
Sites 9

Chronic myeloid leukaemia

The primary objective of this study is to assess the proportion of patients with treatment failure at 12 months after first dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of MMR.

Key facts

Sponsor
Stichting Radboud universitair medisch centrum
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration
14 Nov 2024 → ongoing
Decision date (initial)
2024-09-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No

External identifiers

EU CT number
2024-516511-24-00
EudraCT number
2021-006581-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy

The primary objective of this study is to assess the proportion of patients with treatment failure at 12 months after first dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of MMR.

Conditions and MedDRA coding

Chronic myeloid leukaemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Aged ≥ 18 years -Diagnosed with chronic phase CML - treated with a TKI (imatinib, bosutinib, dasatinib, nilotinib, ponatinib, there are no restrictions regarding using a lower than standard dose at inclusion, or previously having switched from TKI due to toxicity - major molecular response (MMR) or better for an uninterrupted period of at least 6 months at inclusion date - Able and willing to participate - Has provided written informed consent

Exclusion criteria 1

  1. - Inability to understand the nature and extent of the trial and the procedures required (left at the discretion of the treating physician) - Previous loss of MMR on a reduced TKI dose due to intolerability - Molecular or cytogenetic failure to previous TKI - Previous allogeneic hematopoietic stem cell transplantation - CML in accelerated phase or blast crisis - Pregnancy or lactation - Life expectancy ≤ 1 year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary study outcome is the proportion of patients with treatment failure at 12 months after first dose reduction.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Ponatinib

SCP165155 · ATC

Active substance
Ponatinib
Substance synonyms
AP-24534, 3-(2-(IMIDAZO(1,2-B)PYRIDAZIN-3-YL)ETHYNYL)-4-METHYL-N-(4-((4-METHYLPIPERAZIN-1- YL)METHYL)-3-(TRIFLUOROMETHYL)PHENYL)BENZAMIDE, Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-
Route of administration
ORAL
Max daily dose
45 mg milligram(s)
Max total dose
45 mg milligram(s)
Max treatment duration
58 Month(s)
Authorisation status
Authorised
ATC code
L01EA05 — PONATINIB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imatinib Mesilate

SCP10367371 · ATC

Active substance
Imatinib Mesilate
Substance synonyms
IMATINIB MESYLATE
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
800 mg milligram(s)
Max treatment duration
58 Week(s)
Authorisation status
Authorised
ATC code
L01EA01 — IMATINIB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dasatinib

SCP106366169 · ATC

Active substance
Dasatinib
Substance synonyms
BMS354825, N-(2-CHLORO-6-METHYLPHENYL)-2-((6-(4-(2-HYDROXYETHYL)-1-PIPERAZINYL)-2-METHYL-4-PYRIMIDINYL)AMINO)-5-THIAZOLECARBOXAMIDE, BMS-354825
Route of administration
ORAL
Max daily dose
140 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
58 Month(s)
Authorisation status
Authorised
ATC code
L01EA02 — DASATINIB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bosutinib

SCP154038 · ATC

Active substance
Bosutinib
Substance synonyms
SKI-606
Route of administration
ORAL
Max daily dose
500 mg milligram(s)
Max total dose
500 mg milligram(s)
Max treatment duration
58 Month(s)
Authorisation status
Authorised
ATC code
L01XE14 — BOSUTINIB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nilotinib

SCP245943 · ATC

Active substance
Nilotinib
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
58 Month(s)
Authorisation status
Authorised
ATC code
L01XE08 — NILOTINIB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

24 Total trials 12 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Stichting Radboud universitair medisch centrum
Address
Geert Grooteplein Zuid 10
City
Nijmegen
Postcode
6525 GA
Country
Netherlands

Scientific contact point

Organisation
Stichting Radboud universitair medisch centrum
Contact name
Nicole Blijlevens

Public contact point

Organisation
Stichting Radboud universitair medisch centrum
Contact name
Nicole Blijlevens

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruitment ended 136 9
Rest of world — 0 —

Investigational sites

Netherlands

9 sites · Ongoing, recruitment ended
Medisch Centrum Leeuwarden B.V.
Hematology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Zuyderland Medisch Centrum Stichting
Hematology, Henri Dunantstraat 5, 6419 PC, Heerlen
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Radboud universitair medisch centrum Stichting
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Reinier de Graaf Groep
Hematology, Reinier De Graafweg 5, 2625 AD, Delft
Catharina Ziekenhuis Stichting
Hematology, Michelangelolaan 2, 5623 EJ, Eindhoven
Albert Schweitzer Ziekenhuis
Hematology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-11-14 2024-11-14 2024-11-15

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D2_Protocol modification nr 2 2024-516511-24-00 2
Recruitment arrangements (for publication) Placeholder 1
Subject information and informed consent form (for publication) L1_SIS and ICF RODEO Informed consent form 1
Subject information and informed consent form (for publication) L2_Other subject information material Aanvulling op PIF HEMCML28 - RODEO 1.1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC bosulif 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC iclusig 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC imatinib 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC sprycel 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC tasigna 1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS 2024-516511-24-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-03 Netherlands Acceptable with conditions
2024-09-26
 2024-09-26
2 SUBSTANTIAL MODIFICATION SM-1 2024-09-30 Netherlands Acceptable
2024-11-14
 2024-11-14

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