LSTA1 for subjects with newly diagnosed Glioblastoma Multiforme when added to standard of care (temozolomide) versus temozolomide

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Tartu University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Dec 2023 → ongoing

Decision date (initial)

2023-10-17

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Lisata Theraputics, Inc.

External identifiers

EU CT number

2023-506813-23-00

WHO UTN

U1111-1294-1140

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine the effect of LSTA1 in combination with TMZ on survival relative to matching LSTA1 placebo in combination with temozolomide in patients with newly diagnosed GBM

Secondary objectives 5

1. To determine the effect of LSTA1 on milestone survival endpoints 12-month survival and 24-month survival
2. To determine the effect of LSTA1 on PFS
3. To determine the effect of LSTA1 on response rate
4. To determine the effect of LSTA1 on duration of response (DOR) in responding patients with measurable disease at baseline
5. To determine any impact of LSTA1 in combination with TMZ on quality-of-life measures

Conditions and MedDRA coding

Glioblastoma Multiforme

Study design 7 periods

Regulatory references

Plan to share IPD

Yes

IPD plan description

Lisata Therapeutics team members have access to pseudonymised study data in REDCap database.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent
2. Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification
3. Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks
4. Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks)
5. Subjects must be able to undergo serial MRIs (computerized tomography may not be a substitute for magnetic resonance imaging [MRI]).
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
7. Life expectancy ≥ 3 months, as determined by the investigator
8. Patient may have- or continue to receive corticosteroids, by s/he must be on a stable or decreasing dose for at least 14 days prior to randomization
9. Subjects must have adequate organ and marrow function
10. Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention)
11. Adequate contraception

Exclusion criteria 12

1. Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor
2. Patients who received prior Gliadel wafers
3. Patients with concurrent stereotactic radiosurgery or brachytherapy
4. Patients with extracranial metastatic disease
5. Patients with leptomeningeal dissemination
6. Progression of GBM during or after the standard-of-care radiotherapy and TMZ 6-week regimen.
7. Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1 by MRI. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study
8. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment
9. Participation in another interventional clinical study within the last 1 year
10. Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
11. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival: Median time from randomization until death due to any cause

Secondary endpoints 8

1. 12-month survival
2. 24-month survival
3. Median progression-free survival (PFS) based on RANO criteria PFS at 6 months
4. Median progression-free survival (PFS) based on RANO criteria PFS at 12 months
5. ORR: the number of patients with documented partial or complete response (PR or CR) based on RANO criteria, relative to the screening tumor measurement, divided by the number of patients evaluable for response.
6. Disease control rate
7. Duration of response (DOR) for a subset of responding patients with measurable disease at baseline
8. Scores on EORTC QLQ-30

Investigational products

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

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tartu University Hospital

Sponsor organisation

Tartu University Hospital

Address

L. Puusepa Tn 1a

City

Tartu Linn

Postcode

50406

Country

Estonia

Scientific contact point

Organisation

Tartu University Hospital

Contact name

Lenne-Triin Kõrgvee

Public contact point

Organisation

Tartu University Hospital

Contact name

Lenne-Triin Kõrgvee

Locations

3 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 66 files

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

Application history

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