Clinical trial NCT04861207: Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes
Official title: Assessment of Tolerance and Effectiveness of Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia Myelodysplastic Syndromes
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2021-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The probability of progression-free survival in 24 month follow up
timeFrame: 24 month follow up
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 24 month follow up
measure: 24-month overall survival probability
timeFrame: 24 month follow up
measure: Disease recurrence probability.
timeFrame: 24 month follow up
measure: Mortality unrelated with disease recurrence
timeFrame: 24 month follow up
measure: Likelihood of acute and chronic graft-versus-host disease
timeFrame: 24 month follow up
measure: Time of neutrophil and platelet implantation
timeFrame: 24 month follow up
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Study officials:
References: