A multicenter, single-arm phase II study to assess the safety, tolerability, and efficacy of Isatuximab in adult patients with cytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia

Start 22 Oct 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 18 sites · Protocol GMALL-Isatuximab

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 40

Countries 1

Sites 18

Cytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia

Cohort 1: To evaluate safety and efficacy of Isatuximab as part of a combination chemotherapy regimen for R/R T-ALL Cohort 2: To evaluate the efficacy of Isatuximab as single drug to induce molecular remission (MolCR) combined in MRD+ T-ALL

Key facts

Sponsor: Goethe University Frankfurt
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: 22 Oct 2024 → ongoing
Decision date (initial): 2024-07-23
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No
Funding sources: Sanofi-Aventis Deutschland GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Cohort 1: To evaluate safety and efficacy of Isatuximab as part of a combination chemotherapy regimen for R/R T-ALL
Cohort 2: To evaluate the efficacy of Isatuximab as single drug to induce molecular remission (MolCR) combined in MRD+ T-ALL

Secondary objectives 11

Efficacy of Isatuximab to induce complete remission (CR), molecular remission (MolCR) and complete molecular remission (cMolCR) in R/R ALL
CR, MolCR, cMolCR at different time-points
Remission duration, relapse-free survival, event-free survival and overall survival
Duration of CR, MolCR and cMolCR
Kinetics of MolCR and cMolCR
Relapse localisation and relapse characteristics
Safety and tolerability
Incidence of CR (ORR), MolCR and cMolCR after 1 and 2 cycles
Isatuximab treatment realization
Outcome of patients with and without SCT after treatment with Isatuximab
Quality of life (QoL)

Conditions and MedDRA coding

Cytologic or molecular relapsed/refractory CD38 positive T-cell acute lymphoblastic leukemia

Version	Level	Code	Term	System organ class
21.1	LLT	10066110	T-cell lymphoblastic leukemia acute	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

Patients with CD38 positive T-ALL fitting either to the definitions for cohort 1 or cohort 2:
Cohort 1: In relapse or with primary refractory disease defined as ≥5% blasts in bone marrow after at least three chemotherapy cycles (induction I-II, consolidation I) with the following additional specifications: • early relapse within 12 months from first achievement of CR or • late relapse later than 12 months from first achievement of CR or • primary refractory disease without any CR or • any relapse after stem cell transplantation or • any refractory relapse, defined as no response to at least one salvage therapy or • any second or later relapse and • Availability of patient material with blast cells (bone marrow or peripheral blood) for central MRD assessment.
Cohort 2: In complete hematological remission (defined as less than 5% blasts in bone marrow and no evidence of extramedullary disease) after at least three chemotherapy cycles (induction I-II, consolidation I) • Detection of quantifiable MRD at a level of ≥10-4, either as molecular failure without prior achievement of molecular remission or molecular relapse after prior achievement of molecular remission • MRD assay at the central reference lab with at least one marker a minimum sensitivity of 10-4 • MRD detection for study inclusion after an interval of at least 2 weeks from last systemic chemotherapy including antibody therapy • (in patients without clonal molecular MRD marker, MRD testing can be based on flow-cytometry established in reference laboratory)
ECOG status: • Cohort 1: 0-2 • Cohort 2: 0-1
Age at least 18 years or older
Evidence of a personally signed and dated informed consent indication that the patient has been informed of all pertinent aspects of the study
Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Regeneration from last chemotherapy defined as follows: • Cohort 1: -Platelets >=10.000/µL (platelet transfusion allowed); - Hemoglobin >=7.5 g/dL (red blood cell transfusion allowed) • Cohort 2: -Neutrophils >=1.000/µL; -Platelets >=50.000/µL; - Hemoglobin >=9 g/dL
Adequate liver function defined as follows: - Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator); - AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator)
Adequate renal function defined as follows: - Serum creatinine ≤ 2 x ULN; - Any serum creatinine level associated with a calculated creatinine clearance >= 40 mL/min
Negative pregnancy test in women of childbearing potential (WOCBP)
WOCBP must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously
Men who are sexually active with a WOCBP must agree to use a barrier method of contraception
Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)

Exclusion criteria 17

Extramedullary involvement except for non-bulky (<7.5 cm) lymph node involvement, splenomegaly, or hepatomegaly
Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment
Patients who have received treatment for leukemia with chemotherapy as follows: • Cohort 1: Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis); • Cohort 2: Any chemotherapy or antibody therapy after the MRD assay leading to study inclusion (exception: intrathecal prophylaxis)
Patients must have recovered from acute non-hematologic toxicity form previous therapies to ≤ grade I unless signs or symptoms are correlated to leukaemia involvement
Prior SCT ≤ 3 months from start of study treatment
Acute GvHD >= grade II or active chronic GvHD requiring systemic treatment
Any systemic GvHD prophylaxis or treatment within 2 weeks from start of study treatment
Known HIV positivity, known hepatitis B surface antigen positivity or known history of hepatitis C
Unstable or severe uncontrolled medical condition e.g. unstable cardiac function or unstable pulmonary condition
Treatment with an investigational agent within 4 weeks from start of study treatment (safety follow-up period of respective study)
Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been treated with radiation or surgery; patients with previous malignancies are eligible if they have been disease free for >= 2 years and do not require any antitumor therapy
Evidence of uncontrolled current serious active infection or recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis
Known allergies, hypersensitivity, or intolerance to Boron or Mannitol, corticosteroids, mAb (including Isatuximab) or human proteins, or their excipients (refer to respective Summary of Product Characteristics), or known sensitivity to mammalian-derived products
Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Pregnant or breastfeeding females
Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Cohort 1: Proportion of patients with complete hematologic response (ORR= CR and CRi) after 2 cycles of induction therapy including Isatuximab (refer to Section 12 for definitions of CR and CRi).

Secondary endpoints 17

Cohort 2: Proportion of patients with molecular response (MolCR) after one cycle of Isatuximab (refer to Section 12 for definitions of molecular response). (Key secondary end point)
Proportion of patients with CR and CRi, MolCR and cMolCR in R/R (cohort 1) after 1 or 2 cycles of induction (best response)
Probability of continuous complete remission (remission duration) at 18 months
Probability of overall survival at 18 months
Probability of relapse-free survival at 18 months
Probability of event-free survival at 18 months
Incidence of relapses and proportion of relapse localisations
Overall incidence and severity of adverse events (CTCAE 5.0) including incidence of GvHD in patients with prior SCT
Evaluation of overall survival, relapse-free survival, remission duration and treatment related mortality in patients with and without SCT in complete remission after therapy
Duration of molecular remission
Treatment realization for Isatuximab
Probability of continuous MolCR and cMolCR and duration of MolCR and cMolCR
Time to MolCR and cMolCR measured by time-point of first achievement
Realization of SCT in patients with CR (ORR), MolCR, cMolCR, SCT parameters and outcome
Evaluation of all endpoints by T-ALL subgroups
Measurement of Quality of Life with EORTC instruments (e.g. EORTC QLQ-C30) at different time-points during treatment
Hospitalisation days

Investigational products

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

Test 13

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587492 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/001
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132767 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/003
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587472 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587491 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Iceland
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587471 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/003
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587470 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/001
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Norway
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587497 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/003
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Norway
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587495 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/003
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Iceland
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587493 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Norway
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132765 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/001
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132766 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8587473 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 10 mg/Kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 25 Week(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/001
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: Iceland
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/14/1268
Modified vs. Marketing Authorisation: No

Bortezomib

SUB20020 · Substance

Active substance: Bortezomib
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 1.3 mg/kg milligram(s)/kilogram
Max total dose: 5.2 mg/kg milligram(s)/kilogram
Max treatment duration: 3 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 11

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRATHECAL
Max daily dose: 4 mg milligram(s)
Max total dose: 16 mg milligram(s)
Max treatment duration: 19 Week(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: 40 mg milligram(s)
Max total dose: 240 mg milligram(s)
Max treatment duration: 22 Week(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: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 45 mg/m2 milligram(s)/sq. meter
Max total dose: 45 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Week(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: 2000 Other
Max total dose: 2000 Other
Max treatment duration: 1 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: INTRATHECAL
Max daily dose: 15 mg milligram(s)
Max total dose: 105 mg milligram(s)
Max treatment duration: 22 Week(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: 380 mg/m2 milligram(s)/sq. meter
Max treatment duration: 19 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vincristine

SUB00059MIG · Substance

Active substance: Vincristine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 2 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 22 Week(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/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 75 mg/m2 milligram(s)/sq. meter
Max total dose: 900 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Week(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/INFUSION
Route of administration: INTRATHECAL
Max daily dose: 40 mg milligram(s)
Max total dose: 160 mg milligram(s)
Max treatment duration: 19 Week(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: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1000 mg/m2 milligram(s)/sq. meter
Max total dose: 2000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Week(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: TABLETS
Route of administration: ORAL
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 7500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 22 Week(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

Goethe University Frankfurt

Sponsor organisation: Goethe University Frankfurt
Address: Theodor-Stern-Kai 7
City: Frankfurt Am Main
Postcode: 60590
Country: Germany

Scientific contact point

Organisation: Goethe University Frankfurt
Contact name: GMALL Studienzentrale

Public contact point

Organisation: Goethe University Frankfurt
Contact name: GMALL Studienzentrale

Locations

1 EU/EEA country · 18 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	40	18
Rest of world	—	0	—

Investigational sites

Germany

18 sites · Ongoing, recruiting

Universitaetsmedizin Goettingen

Department Hematology and Medical Oncology, Robert-Koch-Strasse 40, Weende, Goettingen

Universitaetsklinikum Schleswig-Holstein AöR

Medical Department II, Arnold-Heller-Strasse 3, Brunswik, Kiel

Universitaetsklinikum Augsburg

II Medical Clinic Hematologic, Oncologic Department, Stenglinstrasse 2, Kriegshaber, Augsburg

Klinikum Oldenburg AöR

Universitätsklinik für Innere Medizin – Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg

Universitaet Leipzig

Medical Department for Hematology, Cell Therapy, Hemostaseology and Infectiology, Liebigstrasse 22, Zentrum-Suedost, Leipzig

Universitaetsklinikum Ulm AöR

Department of Internal Medicine III, Albert-Einstein-Allee 23, Eselsberg, Ulm

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Abteilung für Hämatologie, Onkologie und Palliativmedizin, Auerbachstrasse 112, Bad Cannstatt, Stuttgart

Universitaet Muenster

Department of Medicine A, Hematology and Oncology, Albert-Schweitzer-Campus 1, Sentrup, Muenster

Technische Universitaet Dresden

Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden

University Medical Center Hamburg-Eppendorf

II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg

Universitaetsklinikum Heidelberg AöR

Department V, Hematology, Oncology and Rheumatology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg

Charite Universitaetsmedizin Berlin KöR

Department of Hematology, Oncology and Tumorimmunologyt Hämatologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin

Universitaetsklinikum Essen AöR

Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen

Goethe University Frankfurt

Department of Medicine II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Universitaetsklinikum Erlangen AöR

Department of Medicine 5, Ulmenweg 18, Innenstadt, Erlangen

Universitaetsklinikum Duesseldorf AöR

Department of Hematology, Oncology and Clinical Immunology, Moorenstrasse 5, Bilk, Duesseldorf

Klinikum der Universitaet Muenchen AöR

Department of Medicine 3, Marchioninistrasse 15, Hadern, Munich

Gesundheit Nord gGmbH Klinikverbund Bremen

Medizinische Klinik 1, St.-Juergen-Strasse 1, Hulsberg, Bremen

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
Germany	2024-10-22		2024-12-16

Results and documents

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

Documents 5 files

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

Type	Title	Version
Recruitment arrangements (for publication)	K1_Recruitment_arrangements	1
Subject information and informed consent form (for publication)	L1_SIS_and_ICF_2023-507899-47-00_DE	1
Subject information and informed consent form (for publication)	L2_patient_study_card	1
Subject information and informed consent form (for publication)	L2_questionnaire_EQ5D	1
Subject information and informed consent form (for publication)	L2_questionnaire_QLQ-C30	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-04-18	Germany	Acceptable 2024-07-18	2024-07-23
2	SUBSTANTIAL MODIFICATION	SM-1	2025-10-24	Germany	Acceptable	2025-12-08