Single-arm interventional study with ruxolitinib and AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.

Start 18 Nov 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 15 sites · Protocol Rux-cALL-Pol 2020

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)

Status Ongoing, recruiting

Participants planned 25

Countries 1

Sites 15

Acute lymphoblastic leukemia

Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control.

Key facts

Sponsor: Medical University Of Lodz
Participant type: Pediatric, Patients
Age range: 0-17 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 18 Nov 2024 → ongoing
Decision date (initial): 2024-11-18
Transition trial: Yes
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes

External identifiers

EU CT number: 2024-518316-39-00
EudraCT number: 2020-005019-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control.

Secondary objectives 2

Compare the change of absolute MRD count across TP1 and TP2 in ruxolitinib + Consol. IB ext. to that in appropriate external control.
Evaluate the safety and tolerability of ruxolitinib + Consol. IB ext. to appropriate external control.

Conditions and MedDRA coding

Acute lymphoblastic leukemia

Version	Level	Code	Term	System organ class
21.0	LLT	10000845	Acute lymphoblastic leukemia	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Newly diagnosed ALL treated according to AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care protocol.
Confirmed genetic lesion causing activation of JAK-STAT pathway (CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells`surface).
Stratification as early high risk: - no complete remission on day 33 OR - positivity for KMT2A-AFF1 OR - positivity for TCF3-HLF OR o hypodiploidy <45 chromosomes OR - FCM-MRD in bone marrow on day 15 ≥ 10% and not ETV6-RUNX1 positive OR - IKZF1plus and PCR-MRD at TP1 positive or inconclusive and not positive for ETV6-RUNX1, TCF3-PBX1 or KMT2A rearr. other than KMT2A-AFF1 OR - PCR-MRD at TP1 ≥ 5x10-4 OR -age < 1 year and any KMT2A rearrangement

Exclusion criteria 4

ALL classified as a standard or intermediate risk (SR, MR).
Early high risk (eHR) ALL without genetic lesions within CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells.
Participation in another clinical trial except for ad-on trials within the scope of supportive care approved by the sponsor
Other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Proportion of patients with MRD(-) at TP2.

Secondary endpoints 2

Frequency and grading of adverse events in Consol. IB ext. phase (number, percentage, number per patient-days, number per each grade of significance).
Incidence of treatment-related adverse and severe adverse events.

Investigational products

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

Test 24

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance: Doxorubicin Hydrochloride
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 30 mg/m2 milligram(s)/sq. meter
Max total dose: 180 mg/m2 milligram(s)/sq. meter
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ruxolitinib

SUB32273 · Substance

Active substance: Ruxolitinib
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 80 mg/m2 milligram(s)/sq. meter
Max total dose: 2240 mg/m2 milligram(s)/sq. meter
Max treatment duration: 28 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ruxolitinib

SUB32273 · Substance

Active substance: Ruxolitinib
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 80 mg/m2 milligram(s)/sq. meter
Max total dose: 2240 mg/m2 milligram(s)/sq. meter
Max treatment duration: 28 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SUB12149MIG · Substance

Active substance: Mercaptopurine
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 30240 mg/m2 milligram(s)/sq. meter
Max treatment duration: 630 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Asparaginase

SUB12950MIG · Substance

Active substance: Asparaginase
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 20000 IU international unit(s)
Max total dose: 980000 IU international unit(s)
Max treatment duration: 49 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daunorubicin

SUB06917MIG · Substance

Active substance: Daunorubicin
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 30 mg/m2 milligram(s)/sq. meter
Max total dose: 30 mg/m2 milligram(s)/sq. meter
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vindesine Sulfate

SUB05102MIG · Substance

Active substance: Vindesine Sulfate
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 3 mg/m2 milligram(s)/sq. meter
Max total dose: 6 mg/m2 milligram(s)/sq. meter
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ifosfamide

SUB08125MIG · Substance

Active substance: Ifosfamide
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 800 mg/m2 milligram(s)/sq. meter
Max total dose: 400 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ifosfamide

SUB08125MIG · Substance

Active substance: Ifosfamide
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 800 mg/m2 milligram(s)/sq. meter
Max total dose: 4000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cyclophosphamide

SUB06859MIG · Substance

Active substance: Cyclophosphamide
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 1000 mg/m2 milligram(s)/sq. meter
Max total dose: 4500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 8 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance: Vincristine Sulfate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 2 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 10 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cytarabine

SUB06880MIG · Substance

Active substance: Cytarabine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 2000 mg/m2 milligram(s)/sq. meter
Max total dose: 14400 mg/m2 milligram(s)/sq. meter
Max treatment duration: 35 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cytarabine

SUB06880MIG · Substance

Active substance: Cytarabine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 2000 mg/m2 milligram(s)/sq. meter
Max total dose: 14400 mg/m2 milligram(s)/sq. meter
Max treatment duration: 35 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tioguanine

SUB11084MIG · Substance

Active substance: Tioguanine
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 2520 mg/m2 milligram(s)/sq. meter
Max treatment duration: 42 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 868.75 mg/m2 milligram(s)/sq. meter
Max treatment duration: 91 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone Phosphate

SUB01612MIG · Substance

Active substance: Dexamethasone Phosphate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 868.75 mg/m2 milligram(s)/sq. meter
Max treatment duration: 91 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 868.75 mg/m2 milligram(s)/sq. meter
Max treatment duration: 91 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pegaspargase

SUB03666MIG · Substance

Active substance: Pegaspargase
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 3750 IU international unit(s)
Max total dose: 17500 IU international unit(s)
Max treatment duration: 7 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 5000 mg/m2 milligram(s)/sq. meter
Max total dose: 20000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 1600 mg/m2 milligram(s)/sq. meter
Max treatment duration: 80 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 1600 mg/m2 milligram(s)/sq. meter
Max treatment duration: 80 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate Disodium

SUB16442MIG · Substance

Active substance: Methotrexate Disodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 12 mg milligram(s)
Max total dose: 228 mg milligram(s)
Max treatment duration: 19 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 1600 mg/m2 milligram(s)/sq. meter
Max treatment duration: 80 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Etoposide

SUB07337MIG · Substance

Active substance: Etoposide
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 100 mg/m2 milligram(s)/sq. meter
Max total dose: 500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Lodz

Sponsor organisation: Medical University Of Lodz
Address: Al. Tadeusza Kosciuszki 4
City: Lodz
Postcode: 90-419
Country: Poland

Scientific contact point

Organisation: Medical University Of Lodz
Contact name: Wojciech Młynarski

Public contact point

Organisation: Medical University Of Lodz
Contact name: Wojciech Młynarski

Locations

1 EU/EEA country · 15 investigational sites

By country

Country	MS status	Planned subjects	Sites
Poland	Ongoing, recruiting	25	15
Rest of world	—	0	—

Investigational sites

Poland

15 sites · Ongoing, recruiting

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej, Ul. Borowska 213, 50-556, Wroclaw

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach

Oddział Onkologii, Hematologii i Chemioterapii, Klinika Pediatrii, Ul. Medykow 16, 40-752, Katowice

Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie

Klinika Pediatrii, Hemato-Onkologii i Gastroenterologii Dziecięcej, Ul. Unii Lubelskiej 1, 71-252, Szczecin

Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku

Klinika Pediatrii, Onkologii i Hematologii, Ul. Jerzego Waszyngtona 17, 15-274, Bialystok

Wojewodzki Specjalistyczny Szpital Dzieciecy Im. Prof. Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.

Oddział Kliniczny Onkologii i Hematologii Dziecięcej, Ul. Zolnierska 18 A, 10-561, Olsztyn

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach

II Klinika Pediatrii - Oddział Onkologii i Hematologii Dziecięcej, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi

Klinika Pediatrii, Onkologii i Hematologii, Ul Sporna 36/50, 91-738, Lodz

Uniwersytecki Szpital Dzieciecy W Lublinie

Klinika Hematologii, Onkologii i Transplantologii Dziecięcej, Ul. Prof. Antoniego Gebali Nr 6, 20-093, Lublin

Uniwersyteckie Centrum Kliniczne

Klinika Pediatrii, Hematologii i Onkologii, Ul. Debinki 7, 80-211, Gdansk

Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu

Klinika Onkologii, Hematologii i Transplantologii Pediatrycznej, Ul. Szpitalna 27/33, 60-572, Poznan

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach

Katedra i Klinika Pediatrii, Hematologii i Onkologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze

Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie

Klinika Onkohematologii Dziecięcej, Ul. Lwowska 60, 35-301, Rzeszow

Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie

Oddział Kliniczny Pediatrii, Hematologii i Onkologii, Ul. Ulica Zwirki I Wigury 63 A, 02-091, Warsaw

Uniwersytecki Szpital Dzieciecy W Krakowie

Klinika Onkologii i Hematologii Dziecięcej, Ul. Wielicka 265, 30-663, Cracow

Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy

Katedra Pediatrii, Hematologii i Onkologii, Ul. Marii Curie Sklodowskiej 9, 85-094, Bydgoszcz

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Poland	2024-11-18		2024-11-18

Results and documents

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

Documents 28 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-518316-39-00	5.0
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_blank	1
Subject information and informed consent form (for publication)	L1_IS parents_legal guardians and ICF	5.1
Subject information and informed consent form (for publication)	L1_IS parents_legal guardians and ICF_GDPR	5.0
Subject information and informed consent form (for publication)	L1_SIS 11-15 yr	2.0
Subject information and informed consent form (for publication)	L1_SIS 16-18 yr	3.0
Subject information and informed consent form (for publication)	L1_SIS under 11 yr	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ASPARAGINASE	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CYCLOPHOSPHAMIDE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CYTARABINE_20	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CYTARABINE_50	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_DAUNURUBICINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_DEXAMETHASONE_IV	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_DEXAMETHASONE_PO	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_DOXORUBICINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ETOPOSIDE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_IFOSFAMIDE_1	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_IFOSFAMIDE_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_MERCAPTOPURINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_METHOTREXATE_10_IV	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_METHOTREXATE_100_IV	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_METHOTREXATE_PO	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_PEGASPARAGINASE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_RUXOLITINIB	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_THIOGUANINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_VINCRISTINE	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_VINDESINE	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-09-29	Poland	Acceptable 2024-11-12	2024-11-18
2	SUBSTANTIAL MODIFICATION	SM-1	2025-02-04	Poland	Acceptable 2025-04-04	2025-04-04

Single-arm interventional study with ruxolitinib and AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 2

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 3

Exclusion criteria 4

Endpoints

Primary endpoints 1

Secondary endpoints 2

Investigational products

Test 24

Sponsors and contacts

Medical University Of Lodz

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 28 files

Application history

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