A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy B – Relapsed/Refractory Richter Transformation (RT)

2022-501260-18-00 Protocol KT-US-568-0138-B Therapeutic exploratory (Phase II) Ended

Start 14 Apr 2023 · End 28 Jan 2025 · Status Ended · 7 EU/EEA countries · 17 sites · Protocol KT-US-568-0138-B

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 60
Countries 7
Sites 17

Relapsed/refractory Richter Transformation (RT)

The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy B (RT) is to evaluate the efficacy of brexucabtagene au…

Key facts

Sponsor
Kite Pharma Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
14 Apr 2023 → 28 Jan 2025
Decision date (initial)
2023-02-20
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Kite Pharma Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy, Pharmacodynamic

The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy B (RT) is to evaluate the efficacy of brexucabtagene autoleucel on diffuse large B cell lymphoma (DLBCL)-RT in subjects with RT, by determining the objective response rate (ORR) by central assessment.

Secondary objectives 10

  1. The secondary objectives of ZUMA-25 as per the master protocol are: •To evaluate the Complete Response (CR) by central assessment as defined within each substudy.
  2. •Determine response durability
  3. •Determine survival status
  4. •Determine survival status without progression
  5. •Determine the time to next treatment (TTNT) after administration of brexucabtagene autoleucel
  6. •Determine the time to first response
  7. Substudy B (RT) specific secondary objectives are:
  8. • To evaluate the efficacy of brexucabtagene autoleucel on DLBCL-RT in subjects with RT, by determining the ORR by investigator assessment
  9. • To evaluate the efficacy of brexucabtagene autoleucel on DLBCL-RT based on clonal relationship to the underlying chronic lymphocytic leukemia (CLL) by central assessment
  10. • To evaluate the efficacy of brexucabtagene autoleucel on the underlying CLL by investigator assessment

Conditions and MedDRA coding

Relapsed/refractory Richter Transformation (RT)

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Food And Drug Administration
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. •Male or female 18 years of age or older at the time of signing the informed consent
  2. •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
  3. •ECOG performance status score of 0 or 1.
  4. •Adequate hematologic and end-organ function.
  5. •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
  6. • Confirmed diagnosis of CLL based on IWCLL 2018 criteria Hallek et al 2018 (Substudy protocol section 12.3.2), with histologically confirmed RT to a DLBCL subtype
  7. • Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:
  8. a) Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy
  9. b) Relapsed disease, defined as complete remission to first-line therapy followed by biopsy proven disease relapse
  10. • At least 1 measurable lesion based on the Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy

Exclusion criteria 7

  1. •Prior CAR therapy or treatment with any anti-CD19 therapy
  2. •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
  3. •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
  4. •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
  5. • Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma and prolymphocytic leukemia)
  6. •Prior allogeneic stem cell transplant < 3 months prior to screening and/or <4 months prior to planned infusion of brexucabtagene autoleucel.
  7. •Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy B (RT) is ORR, defined as the proportion of subjects who achieve a best response of either complete response (CR) or partial response (PR).
  2. Response will be determined by central assessment per the Lugano Classification (Cheson et al 2014).

Secondary endpoints 10

  1. The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy
  2. • Duration of Response
  3. • Overall Survival
  4. • Progression-free survival
  5. • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment
  6. • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy
  7. Substudy B (RT) specific secondary endpoints are:
  8. •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR. Response will be determined by investigator assessment per the Lugano Classification
  9. •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR by central assessment per the Lugano Classification, in subgroups by clonal relationship to the underlying CLL. Clonality will be assessed by central assessment
  10. •ORR, defined as the proportion of subjects who achieve a best response of either CR, CR with incomplete marrow recovery (CRi), or PR per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria.

Investigational products

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

Test 1

Tecartus 0.4 – 2 × 108 cells dispersion for infusion

PRD8604659 · Product

Active substance
Brexucabtagene Autoleucel
Pharmaceutical form
DISPERSION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
200000000 DF dosage form
Max total dose
200000000 DF dosage form
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
NOTASSIGN — -
Marketing authorisation
EU/1/20/1492/001
MA holder
KITE PHARMA EU B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2344
Modified vs. Marketing Authorisation
No

Auxiliary 19

Betamethasone Sodium Phosphate

SCP881751 · ATC

Active substance
Betamethasone Sodium Phosphate
Substance synonyms
BETAMETHASONE DISODIUM PHOSPHATE
Route of administration
ORAL
Max daily dose
120 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methylprednisolone

SCP26856619 · ATC

Active substance
Methylprednisolone
Substance synonyms
6-METHYLPREDNISOLONE
Route of administration
INTRAVENOUS USE
Max daily dose
3000 mg milligram(s)
Max total dose
36000 mg milligram(s)
Max treatment duration
12 Day(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

L04A · Product

Pharmaceutical form
-
Route of administration
INTRAVENOUS INFUSION
Max daily dose
2400 mg milligram(s)
Max total dose
3200 mg milligram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L04A — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ifosfamide

SCP5478032 · ATC

Active substance
Ifosfamide
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
5000 mg/m2 milligram(s)/sq. meter
Max total dose
150000 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01AA06 — IFOSFAMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

SCP45096310 · ATC

Active substance
Alpelisib
Substance synonyms
(2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
8800 mg milligram(s)
Max treatment duration
22 Day(s)
Authorisation status
Authorised
ATC code
L01XX — OTHER ANTINEOPLASTIC AGENTS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SCP1891954 · ATC

Active substance
Oxaliplatin
Route of administration
INTRAVENOUS INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
100 mg/m2 milligram(s)/sq. meter
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

IMBRUVICA 140 mg hard capsules

PRD1729387 · Product

Active substance
Ibrutinib
Substance synonyms
1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
420 mg milligram(s)
Max total dose
10500 mg milligram(s)
Max treatment duration
25 Day(s)
Authorisation status
Authorised
ATC code
L01EL01 — -
Marketing authorisation
EU/1/14/945/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SCP28192792 · ATC

Active substance
Carboplatin
Route of administration
INTRAVENOUS INFUSION
Max daily dose
800 mg milligram(s)
Max total dose
800 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SCP6155697 · ATC

Active substance
Etoposide
Route of administration
INTRAVENOUS INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CB01 — ETOPOSIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinblastine Sulfate

SCP4338931 · ATC

Active substance
Vinblastine Sulfate
Substance synonyms
VINBLASTINE SULPHATE
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
4 mg milligram(s)
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anhydrous Cyclophosphamide

SCP1728208 · ATC

Active substance
Anhydrous Cyclophosphamide
Route of administration
INTRAVENOUS INFUSION
Max daily dose
750 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mesna

SCP4962220 · ATC

Active substance
Mesna
Substance synonyms
SODIUM 2-MERCAPTOETHANESULPHONATE
Route of administration
INTRAVENOUS INJECTION
Max daily dose
540 mg milligram(s)
Max total dose
1620 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
V03AF01 — MESNA
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin

SCP1712543 · ATC

Active substance
Doxorubicin
Substance synonyms
ADRIAMYCIN
Route of administration
INTRAVENOUS INFUSION
Max daily dose
50 mg/m2 milligram(s)/sq. meter
Max total dose
50 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01DB01 — DOXORUBICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

N02B · Product

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
1000 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N02B — OTHER ANALGESICS AND ANTIPYRETICS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

R06A · Product

Pharmaceutical form
-
Route of administration
ORAL AND IV
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
R06A — ANTIHISTAMINES FOR SYSTEMIC USE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rituximab

SCP24437829 · ATC

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Route of administration
INTRAVENOUS USE
Max daily dose
375 mg/m2 milligram(s)/sq. meter
Max total dose
375 mg/m2 milligram(s)/sq. meter
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XC02 — RITUXIMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fludarabine

SCP9025814 · ATC

Active substance
Fludarabine
Route of administration
INTRAVENOUS INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
90 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01BB05 — FLUDARABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SCP1686259 · ATC

Active substance
Gemcitabine
Route of administration
INTRAVENOUS INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
1000 mg/m2 milligram(s)/sq. meter
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamethasone Sodium Phosphate Ph. Eur

SCP1977137 · ATC

Active substance
Betamethasone Sodium Phosphate Ph. Eur
Substance synonyms
DEXAMETHASONE SODIUM PHOSPHATE PH. EUR
Route of administration
ORAL AND IV
Max daily dose
40 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
12 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kite Pharma Inc.

13 Total trials 3 Recruiting 10 Ended
Commercial
Sponsor organisation
Kite Pharma Inc.
Address
2225 Colorado Avenue
City
Santa Monica
Postcode
90404-3505
Country
United States

Scientific contact point

Organisation
Kite Pharma Inc.
Contact name
EU Clinical Trials Support

Public contact point

Organisation
Kite Pharma Inc.
Contact name
EU Clinical Trials Support

Third parties 10

OrganisationCity, countryDuties
PPD Global Limited
ORG-100007533
 Cambridge, United Kingdom Other, Code 5
Cellcarta Fremont LLC
ORG-100042774
 Fremont, United States Other, Laboratory analysis
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Other, Laboratory analysis
Nanostring Technologies Inc.
ORG-100044077
 Seattle, United States Other, Laboratory analysis
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other, E-data capture
Bioclinica Inc.
ORG-100033079
 Princeton, United States Other, Data management
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Other, Laboratory analysis
Neogenomics Laboratories Inc.
ORG-100041804
 Aliso Viejo, United States Other, Laboratory analysis
Labcorp Central Laboratories Services LP
ORG-100032236
 Indianapolis, United States Other, Laboratory analysis
Eurofins Viracor Biopharma Services Inc.
ORG-100041736
 Lenexa, United States Other, Laboratory analysis

Locations

7 EU/EEA countries · 17 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 2 1
France Ended 8 4
Germany Ended 6 3
Italy Ended 8 3
Netherlands Ended 2 1
Spain Ended 7 4
Sweden Ended 2 1
Rest of world
Canada, United States, United Kingdom
 — 25 —

Investigational sites

Austria

1 site · Ended
Medical University Of Vienna
Department of Medicine I, Division of Hematology, Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna

France

4 sites · Ended
Pitie Salpetriere Hospital
NA, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Regional Universitaire De Lille
Hopital Claude Huriez, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Service d'Hematologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Lyon Sud
Service d'Hematologie Clinique, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex

Germany

3 sites · Ended
Heidelberg University Hospital AöR
Klinik für Hämatologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Hospital Cologne AöR
Centrum für Integrierte Onkologie (CIO), Studienzentrum der Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitatsklinikum Ulm AöR
Klinik für Innere Medizin III – Hämatologie, Onkologie, Rheumatologie, Infektionskrankheiten, Albert-Einstein-Allee 23, Eselsberg, Ulm

Italy

3 sites · Ended
Hospital Santa Maria Della Misericordia
Struttura Complessa di Ematologia con Trapianto e Sezione di Ematologia ed Immunologia Clinica, Piazzale Giorgio Menghini 1, 06129, Perugia
S Orsola Policlinic Hospital
UOC di Ematologia Dipartimento Malattie Oncologiche ed Ematologiche, Via Giuseppe Massarenti 9, 40138, Bologna
Azienda Ospedaliera Ospedale Niguarda Ca Granda
S.C. Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Netherlands

1 site · Ended
Stichting Radboud University Medical Center
Department of Hematology, 476, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Spain

4 sites · Ended
Hospital General Universitario Gregorio Maranon
Servicio de Hematologia y Hemoterapia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
University Hospital Virgen Del Rocio S.L.
Hematology & Hemotherapy, Avenida De Manuel Siurot S/n, 41013, Sevilla

Sweden

1 site · Ended
Region Skane - Skanes Universitetssjukhus
VO Hematologi, Onkologi & Strålningsfysik, Entregatan 7, Lunds Allhelgonafors, Lund

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-11-17 2023-12-05
France 2023-07-06
Germany 2023-08-30 2023-08-30
Italy 2023-06-23 2025-01-27 2023-07-03 2024-03-13
Netherlands 2023-04-14
Spain 2023-04-27

Results and documents

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

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
KT-US-568-0138 B CTIS Results
SUM-116042
 2026-01-22T15:37:29 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
KT-US-568-0138-B Plain Language Summary 2026-01-22T15:35:51 Submitted Laypersons Summary of Results

Documents 51 files

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

TypeTitleVersion
Laypersons summary of results (for publication) KT-US-568-0138-B Plain Language Summary_DE 1
Laypersons summary of results (for publication) KT-US-568-0138-B Plain Language Summary_IT 1
Protocol (for publication) D4_ Patient facing documents_AT_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_DE_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_DE_Health questionnaire 1
Protocol (for publication) D4_ Patient facing documents_ENG_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_ES_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_ES_Health questionnaire 1
Protocol (for publication) D4_ Patient facing documents_FR_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_FR_Health questionnaire 1.2
Protocol (for publication) D4_ Patient facing documents_IT_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_NL_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_NL_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_SE_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_SE_Health questionnaire 1.1
Protocol (for publication) D4_Patient facing documents_IT_EORTC QLQ questionnaire 3
Protocol (for publication) D5_Master Protocol Administrative_2022-501260-18-00_redacted 1
Protocol (for publication) D5_Master Protocol_2022-501260-18-00_redacted 3.0
Protocol (for publication) D5_Master Protocol_2022-501260-18-00_redacted_TC 1.1
Protocol (for publication) D5_Sub Protocol_2022-501260-18-00_redacted_TC 1.1
Protocol (for publication) D5_Sub-Protocol Administrative_2022-501260-18-00_redacted 1
Protocol (for publication) D5_Sub-Protocol_2022-501260-18-00_redacted 3.0
Summary of results (for publication) KT-US-568-0138 B CTIS Results Final PDF 1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_AT_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_AT_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_DE_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_ES_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_FR_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_FR_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_IT_2022-501260-18-00 3
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_IT_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_NL_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_NL_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_ Master Protocol synopsis_SE_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Sub- Protocol synopsis_NL_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Sub-Protocol synopsis_AT_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Sub-Protocol synopsis_DE_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Sub-Protocol synopsis_ES_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_ Sub-Protocol synopsis_IT_2022-501260-18-00 3
Synopsis of the protocol (for publication) D2_ Sub-Protocol synopsis_SE_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_Master Protocol synopsis_DE_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_Master Protocol synopsis_ES_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Master Protocol synopsis_SE_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_AT_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_DE_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_ES_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_FR_2022-501260-18-00 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_FR_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_IT_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_NL_2022-501260-18-00_TC 1.1
Synopsis of the protocol (for publication) D2_Sub-Protocol synopsis_SE_2022-501260-18-00_TC 1.1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-10-07 Spain Acceptable
2023-02-13
 2023-02-13
2 SUBSTANTIAL MODIFICATION SM-1 2023-03-07 Acceptable 2023-04-19
3 SUBSTANTIAL MODIFICATION SM-2 2023-03-24 Acceptable 2023-05-16
4 SUBSTANTIAL MODIFICATION SM-3 2023-03-28 Spain Acceptable 2023-05-10
5 NON SUBSTANTIAL MODIFICATION NSM-1 2023-05-16 2023-05-16
6 SUBSTANTIAL MODIFICATION SM-7 2024-05-16 Spain Acceptable
2024-07-24
 2024-07-24
7 SUBSTANTIAL MODIFICATION SM-8 2024-11-14 Acceptable
2025-02-17
 2025-02-21