CLADRIBINE for Acute myeloid leukemia | Myelodysplastic syndromes

Inclusion criteria

• {"criterion_text":"- Age between 18 and 60 years (inclusive).\n- Patient is a candidate for allo-HSCT due to AML (intermediate or high risk AML in complete remission, low risk with positive MRD) or high risk myelodysplastic syndrome.\n- Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.\n- Patient signed informed consent form (ICF) prior to any study related screening procedures are performed.\n- Patient has ECOG performance status score of 0 or 1.\n- Patient is a candidate for allo-HSCT from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor."}

Exclusion criteria

• {"criterion_text":"- Has recived more than 1 allo-HCT.\n- Women of childbearing potential who do not agree tmoust use two effective methods of contraception.\n- Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).\n- Known active HIV, HBV or HCV infection (positive PCR test) or risk of HBV reactivation (HBsAg positive).\n- Presence of active disease in AML patients.\n- History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.\n- Presence of severely renal or liver dysfunction (creatinine, ALT, AST or bilirubin concentration > 3.0 ULN (upper limit of normal).\n- Currently pregnancy or breast feeding.\n- Treatment of any other investigational agent in the same time as this study.\n- Known allergies, hypersensivity, or intolerance to cladribine or similar compounds."}

Primary endpoints

• {"endpoint_text":"- The probability of progression-free survival in 24 month FU.","definition_or_measurement_approach":"\"The main objective of the CLARA STUDY is to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML and myelodysplastic syndromes. The primary research question of this project is to determine the percentage of patients with progression-free survival in 24 month FU\" (measured as the percentage/probability of patients progression-free at 24 months follow-up)."}

Secondary endpoints

• {"endpoint_text":"- Frequency of adverse events in 24 month FU.","definition_or_measurement_approach":"Measured as frequency/rate of adverse events occurring during 24 months follow-up."}
• {"endpoint_text":"- 24-month overall survival probability.","definition_or_measurement_approach":"Measured as probability/percentage of patients alive at 24 months follow-up."}
• {"endpoint_text":"- Disease recurrence probability.","definition_or_measurement_approach":"Measured as probability/percentage of patients with disease recurrence during follow-up (24 months referenced in objectives)."}
• {"endpoint_text":"- Mortality unrelated with disease recurrence.","definition_or_measurement_approach":"Measured as deaths not related to disease recurrence during follow-up period."}
• {"endpoint_text":"- Likelihood of acute and chronic graft-versus-host disease.","definition_or_measurement_approach":"Measured as incidence/rate of acute and chronic GvHD during follow-up."}
• {"endpoint_text":"- Time of neutrophil and platelet implantation.","definition_or_measurement_approach":"Measured as time to neutrophil and platelet engraftment post-transplant."}

Poland

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

02-04-2025

Processing Time Days

173

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"KCRI Sp. z o.o.","duties_or_roles":"sponsor duties codes: 1,11,12,5,6,7,8","organisation_type":"Pharmaceutical company"}