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

NCT ID: NCT04861207

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cladribine

Group Type: EXPERIMENTAL

Cladribine

Intervention Type: 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.

Interventions

Cladribine

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Gliwice, , Poland

Countries

Poland

Other Identifiers

20-NIO-0001

Identifier Type: -

Identifier Source: org_study_id