NCT05029531

Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)

Recruiting now Phase 3 Last updated 28 June 2024

What this trial tests

Phase 3 trial testing the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. in Acute Lymphoblastic Leukemia, Pediatric in 80 participants. Currently enrolling.

Timeline

23 September 2021

Primary endpoint
1 July 2029

1 July 2030

Quick facts

Lead sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	23 September 2021
Primary completion	1 July 2029
Estimated completion	1 July 2030
Sites	1 location across Russia

Drugs / interventions tested

• the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors.

Conditions studied

• Acute Lymphoblastic Leukemia, Pediatric — all drugs for Acute Lymphoblastic Leukemia, Pediatric →
• ALL, Infants — all drugs for ALL, Infants →

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 1 Day to 365 Days, any sex, with Acute Lymphoblastic Leukemia, Pediatric or ALL, Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. Investigators have proposed a two-stage stratification into risk groups:

Initially:

* Standard risk: patients with no rearrangement of the KMT2A gene.
* Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system.
* High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system.

According to the results of induction therapy:

* The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block.
* The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT.
* The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for those who became MRD-negative at the end of induction, "block" chemotherapy for those who were positive at the end of induction, but achieved negativity after HR1 block, blinatumomab with HSCT for those who have preserved the MRD after the HR1 block.
* For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 / CD19 T-cell activator) and HSCT in the first remission was chosen.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Infant Acute Lymphoblastic Leukemia-New Therapeutic Opportunities.
   Kulczycka M, Derlatka K, Tasior J, Sygacz M, et al · · 2024 · cited 5× · PMID 38612531 · DOI 10.3390/ijms25073721
2. Bispecific Antibodies and Other Non-CAR Targeted Therapies and HSCT: Decreased Toxicity for Better Transplant Outcome in Paediatric ALL?
   Kállay KM, Algeri M, Buechner J, Krauss AC. · · 2021 · cited 3× · PMID 35252074 · DOI 10.3389/fped.2021.795833