International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group – IntReALL HR 2010

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Charite Universitaetsmedizin Berlin KöR

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Feb 2018 → ongoing

Decision date (initial)

2024-10-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

National funding organisations in the participating countries · Deutsche Kinderkrebsstiftung

External identifiers

EU CT number

2024-513070-21-00

EudraCT number

2012-000810-12

ClinicalTrials.gov

NCT03590171

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Improvement of CR2 rates after induction with ALL R3 with bortezomib versus without bortezomib in HR relapsed ALL patients

Secondary objectives 1

1. Improvement of EFS and OS rates Improvement of MRD reduction after induction with versus without bortezomib Improvement of MRD load prior to SCT Increasing the proportion of HR patients reaching SCT Prognostic relevance of MRD pre SCT Improvement of CR2 and/or MRD rates during consolidation Toxicity of induction with versus without bortezomib

Conditions and MedDRA coding

Relapsed Acute Lymphoblastic Leukemia (ALL)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
2. Children less than 18 years of age at date of inclusion into the study.
3. Meeting HR criteria (any T BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)
4. Patient enrolled in a participating centre
5. Written informed consent
6. Start of treatment falling into the study period
7. No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL

Exclusion criteria 13

1. BCR-ABL/ t(9;22) positive ALL
2. Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
3. Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
4. Breast feeding
5. Relapse post allogeneic stem-cell transplantation
6. Neuropathy > II°
7. The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
8. Objection to the study participation by a minor patient, able to object
9. Any patient being dependent on the investigator
10. No consent is given for saving and propagation of pseudonymized medical data for study reasons
11. Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders
12. Subjects unwilling or unable to comply with the study procedures
13. Subjects who are legally detained in an official institute

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Randomized induction trial: Improvement of CR2 rates with standard chemotherapy + Bortezomib (Arm B) quantified by cytology compared with standard chemotherapy (Arm A)

Secondary endpoints 1

1. Improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre HSCT, CR2 and MRD rates during consolidation, toxicity of randomized arms

Investigational products

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

Test 1

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Charite Universitaetsmedizin Berlin KöR

Sponsor organisation

Charite Universitaetsmedizin Berlin KöR

Address

Augustenburger Platz 1, Wedding Wedding

City

Berlin

Postcode

13353

Country

Germany

Scientific contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Arend von Stackelberg

Public contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Adriane Napp

Locations

11 EU/EEA countries · 117 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 110 files

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

Application history

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