Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes

NCT04861207 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 20-NIO-0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• The probability of progression-free survival in 24 month follow up

  24 month follow up

Secondary Outcomes (6)

• Frequency of adverse events

  24 month follow up

• 24-month overall survival probability

  24 month follow up

• Disease recurrence probability.

  24 month follow up

• Mortality unrelated with disease recurrence

  24 month follow up

• Likelihood of acute and chronic graft-versus-host disease

  24 month follow up

Study Arms (1)

Cladribine

EXPERIMENTAL

Drug: Cladribine

Interventions

Cladribine DRUG

The conditioning regimen used will be cladribine-based at a dose of 5 mg / m2 for 5 days (iv.) and total body irradiation at a total dose of 12 Gy in three fractions.

Cladribine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• Patient is a candidate for allogeneic hematopoietic cell transplantation due to acute myeloid leukemia(intermediate or high risk acute myeloid leukemia in complete remission, low risk with positive Minimal residual disease) or high risk myelodysplastic syndrome.
• Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
• Patient signed informed consent form prior to any study related screening procedures are performed.
• Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
• Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.

You may not qualify if:

• Has received more than 1 allogeneic hematopoietic cell transplantation.
• Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
• Known active human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection (positive polymerase chain reaction test) or risk of hepatitis B virus reactivation (Hepatitis B surface antigen positive).
• Presence of active disease in acute myeloid leukemia patients.
• History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
• Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration \> 3.0 upper limit of normal
• Currently pregnancy or breast feeding.
• Treatment of any other investigational agent in the same time as this study.
• Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
• Women of childbearing potential who do not agree to use two effective methods of contraception.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• KCRI: collaborator

Study Sites (1)

Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach

Gliwice, 44-101, Poland

Location

MeSH Terms

Interventions

Cladribine

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 27, 2021
• Study Start: October 7, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

PL (1)