Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza ostrej białaczki szpikowej (AML) wg standardów WHO, bez wcześniejszego leczenia
- •Pacjent nie kwalifikuje się do intensywnej chemioterapii
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia oceniony na 0-3 (dla pacjentów 18-74 lata) lub 0-2 (dla pacjentów 75+ lat)
✗ Disqualifies
- •Inny nowotwór zdiagnozowany w ciągu ostatnich 2 lat (z wyjątkami określonymi w protokole)
- •Uczestniczenie w innym badaniu klinicznym w ciągu ostatnich 30 dni
- •Przyjmowanie leków wpływających na metabolizm venetoclaxu w ciągu ostatnich 7 dni
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (13)
Fortis Memorial Research Institute /ID# 268697
Gurgaon, India
Healthcare Global Enterprises Limited (HCGEL) /ID# 272071
Bengaluru, India
Mazumdar Shaw Medical Center /ID# 270677
Bengaluru, India
Regional Cancer Centre /ID# 268785
Thiruvananthapuram, India
Tata Memorial Hospital - Mumbai /ID# 269177
Mumbai, India
LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781
Pune, India
Sahyadri Super Speciality Hospital /ID# 272074
Pune, India
All India Institute Of Medical Sciences - New Delhi /ID# 268357
New Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293
New Delhi, India
All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879
Bhubaneswar, India
Apollo Cancer Centre /ID# 268780
Chennai, India
Cancer Institute (Wia) /ID# 268695
Chennai, India
Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692
Hyderabad, India
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/15/2026.
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