Overview
Sponsor-declared trial summary
Acute myeloid leukemia, myelodysplastic syndromes
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 mo…
Key facts
- Sponsor
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Feb 2022 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Medical Research Agency
External identifiers
- EU CT number
- 2024-517477-24-00
- EudraCT number
- 2020-005325-82
- ClinicalTrials.gov
- NCT04861207
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
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
Secondary objectives 1
- There are several secondary objectives of the clinical trial defined, as: the determining of the percentage of adverse events in the whole FU period, the probability of the 24-month overall survival, the probability of disease recurrence, the rate of mortality unrelated with the disease recurrence, the likelihood of acute and chronic graft-versus-host disease development as well as the time of neutrophil and platelet implantation.
Conditions and MedDRA coding
Acute myeloid leukemia, myelodysplastic syndromes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10028536 | Myelodysplastic syndromes | 10029104 |
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
Exclusion criteria 10
- Has recived more than 1 allo-HCT.
- 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.
- Women of childbearing potential who do not agree tmoust use two effective methods of contraception.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The probability of progression-free survival in 24 month FU.
Secondary endpoints 6
- Frequency of adverse events in 24 month FU.
- 24-month overall survival probability.
- Disease recurrence probability.
- Mortality unrelated with disease recurrence.
- Likelihood of acute and chronic graft-versus-host disease.
- Time of neutrophil and platelet implantation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BIODRIBIN, 1 mg/ml, roztwór do infuzji
PRD802229 · Product
- Active substance
- Cladribine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 5 mg/m2 milligram(s)/square meter
- Max total dose
- 25 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB04 — CLADRIBINE
- Marketing authorisation
- R/7134
- MA holder
- SIEĆ BADAWCZA ŁUKASIEWICZ - INSTYTUT CHEMII PRZEMYSŁOWEJ IMIENIA PROFESORA IGNACEGO MOŚCICKIEGO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Sponsor organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Address
- Ul. Wybrzeze Armii Krajowej 15
- City
- Gliwice
- Postcode
- 44-102
- Country
- Poland
Scientific contact point
- Organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Center
Public contact point
- Organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| KCRI Sp. z o.o. ORG-100027098
|
Cracow, Poland | On site monitoring, Code 11, Code 12, Code 5, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2022-02-17 | 2022-02-17 | 2025-01-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_202451747724_Addendum_blinded | 1.0 |
| Protocol (for publication) | D1_Protocol_202451747724_blinded | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_2024-517477-24 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_for publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_blinded | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_for publication | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Biodribin | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_202451747724_blinded | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_202451747724_blinded | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Poland | Acceptable 2024-11-15
|
2024-11-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-30 | Poland | Acceptable 2024-11-15
|
2024-12-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-03 | Poland | Acceptable | 2025-04-02 |