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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
EU CTIS ID: 2024-517477-24-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 60 years (inclusive).
- 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.
- Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
- Patient signed informed consent form (ICF) prior to any study related screening procedures are performed.
- Patient has ECOG performance status score of 0 or 1.
- Patient is a candidate for allo-HSCT from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
You likely can't join if
- Has recived more than 1 allo-HCT.
- Women of childbearing potential who do not agree tmoust use two effective methods of contraception.
- Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
- Known active HIV, HBV or HCV infection (positive PCR test) or risk of HBV reactivation (HBsAg positive).
- Presence of active disease in AML patients.
- History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
See the full eligibility criteria
- Age between 18 and 60 years (inclusive).
- 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.
- Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
- Patient signed informed consent form (ICF) prior to any study related screening procedures are performed.
- Patient has ECOG performance status score of 0 or 1.
- Patient is a candidate for allo-HSCT from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
- Has recived more than 1 allo-HCT.
- Women of childbearing potential who do not agree tmoust use two effective methods of contraception.
- Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
- Known active HIV, HBV or HCV infection (positive PCR test) or risk of HBV reactivation (HBsAg positive).
- Presence of active disease in AML patients.
- History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
- Presence of severely renal or liver dysfunction (creatinine, ALT, AST or bilirubin concentration > 3.0 ULN (upper limit of normal).
- Currently pregnancy or breast feeding.
- Treatment of any other investigational agent in the same time as this study.
- Known allergies, hypersensivity, or intolerance to cladribine or similar compounds.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.