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New treatment option for Acute Myeloid Leukemia in Remission
Official title Pilot Study of Reduced Venetoclax Exposure
ClinicalTrials.gov ID: NCT07163793
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia in remission.
Also referred to as Vidaza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pilot Study of Reduced Venetoclax Exposure
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the study regimen
- Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
- 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
- Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
You likely can't join if
- Treatment with another investigational drug
- Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
- On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.
- Subject has received treatment prior to induction with the following: i. Prior hypomethylating agent or BCL-2 inhibitor for either AML or MDS other...
- Subject has: i. Acute promyelocytic leukemia (APL) with t(15;17). ii. Presence of t(9;22) given the potential indication for concurrent tyrosine...
See the full eligibility criteria
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the study regimen
- Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
- 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
- Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
- Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
- Consent to be obtained within 10 days (+/- 3 days) of bone marrow biopsy report showing morphological remission. C1D1 of trial to be initiated within 10 days (+/- 7 days) of bone marrow biopsy report showing...
- ECOG 0-3
- Intensive treatment ineligible; transplant ineligible or refusal of transplant
- Patient must be able to understand and sign informed consent and additional study documents
- On C1D1 of trial, patient must have count recovery with ANC \>1000, platelets \> 50, Hemoglobin \> 7.7 and without transfusion support for 7 days.
- No growth factor (G-CSF) use in 14 days prior to C1 D1 of trial.
- Treatment with another investigational drug
- Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
- On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.
- Subject has received treatment prior to induction with the following: i. Prior hypomethylating agent or BCL-2 inhibitor for either AML or MDS other than for induction prior to enrollment. ii. Prior CAR-T cell therapy...
- Subject has: i. Acute promyelocytic leukemia (APL) with t(15;17). ii. Presence of t(9;22) given the potential indication for concurrent tyrosine kinase therapy. iii. Known active CNS involvement with AML.
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.