Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented confirmation of acute myeloid leukemia (AML) according to the World Health Organization (WHO) criteria, previously untreated [OR]
Documented diagnosis of previously untreated de novo myelodysplastic syndrome (MDS) according to the 2017 WHO classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate.

Participants with documented MDS must meet the following disease activity criteria:

Overall revised international prognostic scoring system (IPSS-R) score > 3 (intermediate, high, or very high);
Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
Hematopoietic stem cell transplant (HSCT) ineligible, or participant who chooses not to undergo HSCT.

Participants with documented AML with adverse cytogenetic and/or molecular risk, and must be considered ineligible for induction therapy defined by the following:

>= 75 years of age; [OR]

>= 18 to 74 years of age with at least one of the following comorbidities: --- Eastern cooperative oncology group (ECOG) performance status of 2 to 3; --- Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina;

Diffusion capacity of lung (DLCO) <= 65% or forced expiratory volume during the first second (FEV1) <= 65%;
Creatinine clearance >= 30 mL/min to < 45 mL/min;
Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × upper limit of normal (ULN);
Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy or the participant declines to receive intensive chemotherapy.

Japan Safety Lead-In Phase:

Documented confirmation of AML according to WHO criteria, relapsed or refractory (R/R) disease without other standard of care treatments.
Documented diagnosis of MDS according to the 2017 WHO classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate, with intermediate- and high-risk relapsed/refractory MDS.

Documented MDS must meet the following disease activity criteria:

ECOG performance status of 0 to 2.

Exclusion Criteria:

Participants with documented AML with acute promyelocytic leukemia and considered eligible for induction therapy.

Participant with documented AML having prior diagnosis of:

-- known active central nervous system involvement with AML.

Participants with documented MDS having prior diagnosis of:

MDS evolving from a pre-existing myeloproliferative neoplasm (MPN);
MDS/MPN including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia and unclassifiable MDS/MPN.
History of allogeneic HSCT or solid organ transplantation.
Previous exposure to anti-CD47 therapies.

History of an active malignancy within the past 2 years prior to Screening, with the exception of:

-- Adequately treated carcinoma in situ of the cervix uteri or carcinoma in situ of the breast;

Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy;
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.

Japan Safety Lead-In Phase:

Documented AML have Acute Promyelocytic Leukemia.

Participant with documented AML having prior diagnosis of:

-- Chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.

Participants with documented MDS having prior diagnosis of:

Therapy-related MDS.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04912063

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 29 Locations for this study

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University of Alabama at Birmingham - Main /ID# 227071
Birmingham Alabama, 35233, United States
Norton Cancer Institute - St Matthews /ID# 228378
Louisville Kentucky, 40207, United States
Massachusetts General Hospital /ID# 227273
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 231083
Boston Massachusetts, 02215, United States
University of Michigan /ID# 227030
Ann Arbor Michigan, 48109, United States
University of Pennsylvania /ID# 227024
Philadelphia Pennsylvania, 19104, United States
UPMC Hillman Cancer Ctr /ID# 228048
Pittsburgh Pennsylvania, 15232, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 227019
Houston Texas, 77030, United States
University of Virginia Health /ID# 227363
Charlottesville Virginia, 22908, United States
Liverpool Hospital /ID# 227723
Liverpool New South Wales, 2170, Australia
Austin Health /ID# 227717
Heidelberg Victoria, 3084, Australia
Marien Hospital Duesseldorf /ID# 227751
Duesseldorf Nordrhein-Westfalen, 40479, Germany
Universitaetsklinikum Leipzig /ID# 227750
Leipzig Sachsen, 04103, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 227749
Dresden , 01307, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 227748
Hamburg , 20246, Germany
The Chaim Sheba Medical Center /ID# 227389
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 227387
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 227275
Jerusalem Yerushalayim, 91120, Israel
Rabin Medical Center /ID# 227738
Petakh Tikva , 49414, Israel
Istituto Clinico Humanitas /ID# 226948
Rozzano Milano, 20089, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 226950
Bologna , 40138, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 226952
Milano , 20162, Italy
National Cancer Center Hospital East /ID# 232498
Kashiwa-shi Chiba, 277-8, Japan
University of Fukui Hospital /ID# 232466
Yoshida-gun Fukui, 910-1, Japan
Kyushu University Hospital /ID# 232564
Fukuoka-shi Fukuoka, 812-8, Japan
Yamagata University Hospital /ID# 232451
Yamagata-shi Yamagata, 990-9, Japan
Hospital Clinic de Barcelona /ID# 227772
Barcelona , 08036, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 227771
Madrid , 28040, Spain
Hospital Universitario Virgen de la Victoria /ID# 227770
Malaga , 29010, Spain

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04912063

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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