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

Phase 2

Active, not recruiting

• Conditions: Acute Myeloid Leukemia Myelodysplastic Syndromes
• Interventions: Drug: Cladribine

• Registration Number: NCT04861207
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-27
• Study Start: 2021-10-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age between 18 and 60 years.
2. 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.
3. Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
4. Patient signed informed consent form prior to any study related screening procedures are performed.
5. Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
6. Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.

Exclusion Criteria

1. Has received more than 1 allogeneic hematopoietic cell transplantation.
2. Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
3. 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).
4. Presence of active disease in acute myeloid leukemia patients.
5. History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
6. Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration > 3.0 upper limit of normal
7. Currently pregnancy or breast feeding.
8. Treatment of any other investigational agent in the same time as this study.
9. Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
10. Women of childbearing potential who do not agree to use two effective methods of contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cladribine	Cladribine	-

Primary Outcome Measures

Name	Time	Method
The probability of progression-free survival in 24 month follow up	24 month follow up

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events	24 month follow up
24-month overall survival probability	24 month follow up
Likelihood of acute and chronic graft-versus-host disease	24 month follow up
Time of neutrophil and platelet implantation	24 month follow up
Mortality unrelated with disease recurrence	24 month follow up
Disease recurrence probability.	24 month follow up

Trial Locations

Locations (1)

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