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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 standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.
The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.
Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax in Combination with Azacitidine | Experimental | Participants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s | TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug. | Up to Approximately 29 Months |
| Percentage of Participants with Post-Baseline Laboratory Abnormalities | Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). | Up to Approximately 29 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission (CRc) | (CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment. | Up to Approximately 29 Months |
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Inclusion Criteria:
Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Memorial Research Institute /ID# 268697 | Recruiting | Gurgaon | Haryana | 122002 | India | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Azacitidine |
| Drug |
Subcutaneous (SC) Injection |
|
| Azacitidine | Drug | Intravenous (IV) Injection |
|
| Composite Complete Remission (CRc) by initiation of Cycle 2 |
(CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment. |
| Up to Approximately 1 Month |
| Complete Remission | CR is defined as the modified IWG response criteria for AML in participants who received venetoclax and azacitidine combination study treatment. | Up to Approximately 29 Months |
| Overall Survival (OS) | OS is defined as the time measured from randomization until death from any cause. | Up to Approximately 29 Months |
| Mazumdar Shaw Medical Center /ID# 270677 |
| Recruiting |
| Bengaluru |
| Karnataka |
| 560099 |
| India |
| Regional Cancer Centre /ID# 268785 | Recruiting | Thiruvananthapuram | Kerala | 695011 | India |
| LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781 | Recruiting | Pune | Maharashtra | 411004 | India |
| Sahyadri Super Speciality Hospital /ID# 272074 | Recruiting | Pune | Maharashtra | 411004 | India |
| All India Institute Of Medical Sciences - New Delhi /ID# 268357 | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293 | Recruiting | New Delhi | National Capital Territory of Delhi | 110085 | India |
| All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879 | Recruiting | Bhubaneswar | Odisha | 751019 | India |
| Apollo Cancer Centre /ID# 268780 | Recruiting | Chennai | Tamil Nadu | 600035 | India |
| Cancer Institute (Wia) /ID# 268695 | Recruiting | Chennai | Tamil Nadu | 600036 | India |
| Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692 | Recruiting | Hyderabad | Telangana | 500034 | India |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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