Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes With CA-4948 (LUCAS)
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|ClinicalTrials.gov Identifier: NCT05178342|
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : January 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Anemia||Drug: CA-4948||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)|
|Actual Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2025|
Single-arm design. all patients are treated with IMP
Patients will be treated orally with CA-4948 at 300 mg BID (2x300mg) over 4 cycles. One cycle consists of 28 days, 21 of which are treatment days, followed by 7 days off.
Patients with erythroid response (HI-E) after 4 cycles who tolerate CA-4948 may continue to receive CA-4948 until loss of HI-E response.
- Erythroid response (HI-E) [ Time Frame: At the end of cycle 4 (each cycle is 28 days). ]To evaluate the proportion of patients who have an erythroid response (HI-E) according to the modified IWG 2018 criteria separately for both independent substudies.
- HI-E response (erythroid response) duration [ Time Frame: From the date of treatment start until date of documented loss of response, assessed up to 30 months. ]To evaluate HI-E response from the first day of response until loss of response.
- Time to HI-E (erythroid response) [ Time Frame: From the date of treatment start until first day of response, assessed up to end of cycle 4 (each cycle is 28 days). ]To evaluate the time between start of treatment and first day of response.
- Red blood cell (RBC) transfusions [ Time Frame: From the date of treatment start until the date of end of treatment, assessed up to 30 months. ]To evaluate frequency of red blood cell transfusions in transfusion dependent patients
- Neutrophil (HI-N) responses [ Time Frame: At the end of cycle 4 (each cycle is 28 days). ]Neutrophil (HI-N) responses according to IWG 2018 criteria
- Platelet (HI-P) responses [ Time Frame: At the end of cycle 4 (each cycle is 28 days). ]Platelet (HI-P) responses according to IWG 2018 criteria
- Safety of CA-4948 (toxicities and adverse events) [ Time Frame: From the date of treatment start until the end of study, assessed up to 30 months. ]Assessments will include characterization of toxicities; characterization of AEs including type, incidence, severity, seriousness, and relationship to treatment
- Number of participants with clinically significant changes of selected laborotory parameters (parameters listed in detailed description) [ Time Frame: From the date of treatment start until the end of study, assessed up to 30 months. ]To ensure patient safety, close monitoring is carried and includes the analysis of: transaminases, bilirubin, amylase, lipase, troponin, lactate dehydrogenase, creatine kinase, uric acid, TSH, FT4, urine analysis.
- Impact of treatment assessed by using the validated European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) [ Time Frame: From the date of treatment start until the end of study, assessed up to 30 months. ]
To assess patient-reported quality of life during CA-4948 treatment: 30 questions assessing the quality of life of oncology patients across 10 subscales will be analyzed. All subscales have a score range from 0 to 100 points.
Function subscales: a higher score represents a higher quality of life. Symptoms subscales: higher score represents higher level of symptoms/problems, i.e., represents lower quality of life.
- Impact of treatment assessed by using the validated European Organisation for Research and Treatment of Cancer cancer related fatigue questionnaire (EORTC QLQ- FA12) [ Time Frame: From the date of treatment start until the end of study, assessed up to 30 months. ]To assess patient-reported quality of life during CA-4948 treatment: 12 items, with four response categories for each item (coded with values from 1 to 4) will be analyzed. FA12 scores are transformed to the range 0-100: Higher levels indicate greater degrees of fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178342
|Contact: Uwe Platzbecker, Prof. Dr.||+49 341 97 email@example.com|
|Contact: Anne Sophie Kubasch, Dr.||firstname.lastname@example.org|
|Charité Berlin - Campus Benjamin Franklin, Med. Klinik m. S. Hämatologie, Onkologie, Tumorimmunologie||Recruiting|
|Berlin, Germany, 12200|
|Contact: Kathrin Rieger, Dr.|
|Städtisches Klinikum Braunschweig, Medizinische Klinik III, Hämatologie und Onkologie||Not yet recruiting|
|Braunschweig, Germany, 38114|
|Contact: Heiko Hütten, Dr.|
|Carl-Thiem-Klinikum Cottbus gGmbH, 2. Med. Klinik||Not yet recruiting|
|Cottbus, Germany, 03048|
|Contact: Martin Schmidt-Hieber, PD Dr.|
|Gemeinschaftspraxis Dr. Jacobasch Dresden, Hämatologie Onkologie||Recruiting|
|Dresden, Germany, 01307|
|Contact: Thomas Illmer, PD Dr.|
|Marienhospital Düsseldorf, Klinik für Onkologie und Hämatologie, Palliativmedizin||Not yet recruiting|
|Düsseldorf, Germany, 40479|
|Contact: Aristoteles Giagounidis, Prof. Dr.|
|ONCOSEARCH, Institut für Klinische Studien GbR||Not yet recruiting|
|Erlangen, Germany, 91052|
|Contact: Martina Haibach, Dr.|
|InVO-Institut für Versorgungsforschung in der Onkologie||Not yet recruiting|
|Koblenz, Germany, 56068|
|Contact: Rudolf Weide, Prof. Dr.|
|VK & K Studien GbR, Studienzentrum||Not yet recruiting|
|Landshut, Germany, 84036|
|Contact: Ursula Vehling-Kaiser, Dr.|
|University Leipzig, Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, Hämostaseologie||Recruiting|
|Leipzig, Germany, 04103|
|Contact: Uwe Platzbecker, Prof. Dr.|
|Universitätsklinikum Schleswig-Holstein, Klinik für Hämatologie und Onkologie Campus Lübeck||Not yet recruiting|
|Lübeck, Germany, 23538|
|Contact: Friederike Wortmann, Dr.|
|Universitätsklinikum Mainz, III. Medizinische Klinik und Poliklinik - Hämatologie, Internistische Onkologie und Pneumologie||Not yet recruiting|
|Mainz, Germany, 55131|
|Contact: Markus Radsak, Prof. Dr.|
|Universitätsklinikum Mannheim, III. Medizinische Klinik - Hämatologie und Onkologie||Not yet recruiting|
|Mannheim, Germany, 68167|
|Contact: Mohamad Jawhar, PD Dr.|
|Klinikum Hochsauerland GmbH, Klinik f. Hämatologie, Onkologie, Palliativmedizin, Stammzelltransplantation||Not yet recruiting|
|Meschede, Germany, 59872|
|Contact: Mohammad Amen Wattad, Dr.|
|Friedrich-Ebert-Krankenhaus GmbH, Klinik für Hämatologie, Onkologie und Nephrologie||Not yet recruiting|
|Neumünster, Germany, 24534|
|Contact: Stefan Mahlmann, Dr.|
|Rems-Murr-Kliniken gGmbH, Hämatologie, Onkologie und Palliativmedizin||Not yet recruiting|
|Winnenden, Germany, 71364|
|Contact: Alexander Reichart, Prof. Dr.|
|Principal Investigator:||Uwe Platzbecker, Prof. Dr.||University Leipzig|