Assessment of tolerance and spread of the whole body at myeloablative doses in association with cladribine before allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia - a pilot, single-phase, II phase study

Assessment of tolerance and spread of the whole body at myeloablative doses in association with cladribine before allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia - a pilot, single-phase, II phase study - ClaTBI/2019

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004010-34-PL

Enrollment

Registered

2019-11-05

Start date

2020-05-18

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accute myeloid leukemia MedDRA version: 21.0 Level: LLT Classification code 10028557 Term: Myeloid leukemia, acute System Organ Class: 100000004864

Interventions

Product Name: Cladribine Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patients with acute myeloid leukemia diagnosed with complete remission, - low-risk disease with positive residual disease or intermediate and high risk disease regardless of residual disease status (according to ELN), - demonstrated chemosensitivity after induction treatment with cladribine, - age 18 to 60 years old, - clinical condition according to WHO 0-1, - planned transplantation from a HLA compatible or unrelated family HLA compatible donor, - a negative result towards the active replication of HBV, HCV and HIV, - organ capacity assessment on a WHO scale =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients with known low-risk acute myeloid leukemia with negative residual disease (according to ELN), - demonstration of no chemosensitivity in case of induction treatment with cladribine, - positive pregnancy result, lactation period, - coexistence of another cancer disease, - current severe active infection, - previous hematopoietic cell allotransplantation from the same or different donor.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation and safety of conditioning treatment with cladribine and TBI at a dose of 12 Gy.;Secondary Objective: ;Primary end point(s): • Relapse-free survival (RFS) • Overall survival (OS) • Relapse probability (RI) • Non-relapse mortality (NRM) • Presence of graft versus host disease (GvHD) - acute and chronic • Time to get the implant • Relapse-free and GvHD (GRFS) survival • The frequency of individual side effects;Timepoint(s) of evaluation of this end point: From inclusion in the study to completion of the observation.	—

Measure

Time frame

Main Objective: Evaluation and safety of conditioning treatment with cladribine and TBI at a dose of 12 Gy.;Secondary Objective: ;Primary end point(s): • Relapse-free survival (RFS) • Overall survival (OS) • Relapse probability (RI) • Non-relapse mortality (NRM) • Presence of graft versus host disease (GvHD) - acute and chronic • Time to get the implant • Relapse-free and GvHD (GRFS) survival • The frequency of individual side effects;Timepoint(s) of evaluation of this end point: From inclusion in the study to completion of the observation.

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Countries

Poland

Contacts

Public ContactCOI Centrala

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie – Panstwowy Instytut Badawczy, Oddzial w Gliwicach

onkologia@io.gliwice.pl(32)2788886

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026