Spots Global Cancer Trial Database for Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome
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Trial Identification
Brief Title: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome
Official Title: A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination With Venetoclax and/or Azacitidine in Subjects With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study ID: NCT04912063
Study Description
Brief Summary: Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab is and how it moves within the body when used along with azacitidine and/or venetoclax in adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed. Lemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) and with azacitidine with/without venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in the study in approximately 50 sites worldwide. Participants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC or IV route QD for 7 days of each 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham - Main /ID# 227071, Birmingham, Alabama, United States
Norton Cancer Institute - St Matthews /ID# 228378, Louisville, Kentucky, United States
Massachusetts General Hospital /ID# 227273, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 231083, Boston, Massachusetts, United States
University of Michigan /ID# 227030, Ann Arbor, Michigan, United States
University of Pennsylvania /ID# 227024, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 228048, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 227019, Houston, Texas, United States
University of Virginia Health /ID# 227363, Charlottesville, Virginia, United States
Liverpool Hospital /ID# 227723, Liverpool, New South Wales, Australia
Austin Health /ID# 227717, Heidelberg, Victoria, Australia
Marien Hospital Duesseldorf /ID# 227751, Duesseldorf, Nordrhein-Westfalen, Germany
Universitaetsklinikum Leipzig /ID# 227750, Leipzig, Sachsen, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 227749, Dresden, , Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 227748, Hamburg, , Germany
The Chaim Sheba Medical Center /ID# 227389, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 227387, Tel Aviv-Yafo, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 227275, Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 227738, Petakh Tikva, , Israel
Istituto Clinico Humanitas /ID# 226948, Rozzano, Milano, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 226950, Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 226952, Milano, , Italy
National Cancer Center Hospital East /ID# 232498, Kashiwa-shi, Chiba, Japan
University of Fukui Hospital /ID# 232466, Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 232564, Fukuoka-shi, Fukuoka, Japan
Yamagata University Hospital /ID# 232451, Yamagata-shi, Yamagata, Japan
Hospital Clinic de Barcelona /ID# 227772, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 227771, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 227770, Malaga, , Spain
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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