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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04912063




Registration number
NCT04912063
Ethics application status
Date submitted
28/05/2021
Date registered
3/06/2021

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2021-000514-41
Secondary ID [2] 0 0
M20-866
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Myelodysplastic Syndrome (MDS) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lemzoparlimab
Treatment: Drugs - Azacitidine
Treatment: Drugs - Venetoclax

Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).

Experimental: Lemzoparlimab + Azacitidine in MDS (Escalation) - Lemzoparlimab (TJ011133) co-administered with azacitidine in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).

Experimental: Lemzoparlimab + Azacitidine + Venetoclax in AML (Expansion) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Experimental: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Expansion) - Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).

Experimental: Lemzoparlimab Monotherapy in AML (Japan Only Escalation) - Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Experimental: Lemzoparlimab Monotherapy in MDS (Japan Only Escalation) - Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).


Treatment: Drugs: Lemzoparlimab
Intravenous (IV) Infusion

Treatment: Drugs: Azacitidine
Subcutaneous Injection or Intravenous (IV) Injection/Infusion

Treatment: Drugs: Venetoclax
Oral Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) When Co-administered With Venetoclax and Azacitidine in Participants With Treatment-Naïve Acute Myeloid Leukemia (AML) Ineligible for Standard Induction Therapy
Timepoint [1] 0 0
Up to 30 days after first dose of study drug
Primary outcome [2] 0 0
DLTs of Lemzoparlimab (TJ011133) When Co-administered With Azacitidine With or Without Venetoclax in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndrome (MDS)
Timepoint [2] 0 0
Up to 30 days after first dose of study drug
Primary outcome [3] 0 0
Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with Relapsed/Refractory (R/R) AML
Timepoint [3] 0 0
Up to 30 days after first dose of study drug
Primary outcome [4] 0 0
DLTs of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with R/R MDS
Timepoint [4] 0 0
Up to 30 days after first dose of study drug
Secondary outcome [1] 0 0
Best Overall Response of Complete Remission (CR) for AML
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Best Overall Response of Composite CR (CRc) for AML
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Best Overall Response of CR or Complete Remission With Partial Hematologic Recovery (CRh) for AML
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Duration of Response (DOR) for AML
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Event-Free Survival (EFS) for AML
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Overall Survival (OS ) for AML
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Best Overall Response of CR, for MDS
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Best Overall Response of Marrow-Complete Remission (mCR), for MDS
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Best Overall Response of CR or PR for MDS
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Best Overall Response of CR or PR or mCR, for MDS
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Hematologic Improvement (HI), for MDS
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Red Blood Cell Transfusion Independence (TI), for MDS
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
Platelet TI, for MDS
Timepoint [13] 0 0
Up to approximately 3 years
Secondary outcome [14] 0 0
DOR, for MDS
Timepoint [14] 0 0
Up to approximately 3 years
Secondary outcome [15] 0 0
Progression Free Survival (PFS), for MDS
Timepoint [15] 0 0
Up to approximately 3 years
Secondary outcome [16] 0 0
OS, for MDS
Timepoint [16] 0 0
Up to approximately 3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2023
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 227723 - Liverpool
Recruitment hospital [2] 0 0
Austin Health /ID# 227717 - Heidelberg
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Germany
State/province [8] 0 0
Nordrhein-Westfalen
Country [9] 0 0
Germany
State/province [9] 0 0
Sachsen
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Israel
State/province [12] 0 0
Tel-Aviv
Country [13] 0 0
Israel
State/province [13] 0 0
Yerushalayim
Country [14] 0 0
Israel
State/province [14] 0 0
Petakh Tikva
Country [15] 0 0
Italy
State/province [15] 0 0
Milano
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Japan
State/province [17] 0 0
Chiba
Country [18] 0 0
Japan
State/province [18] 0 0
Fukui
Country [19] 0 0
Japan
State/province [19] 0 0
Fukuoka
Country [20] 0 0
Japan
State/province [20] 0 0
Yamagata
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Malaga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04912063