Clinical trial · Interventional
Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms
Venetoclax and Azacitidine Combination Therapy for Patients With Accelerated or Blast Phase BCR-ABL Negative Myeloproliferative Neoplasm (VAAMP)
NCT05074355CI-TRIAL-00116893recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacitidine and Venetoclax
- description
- A treatment cycle is 28 days long. Azacitidine will be given by injection under the skin, once a day, for the first 6 days of every cycle. Venetoclax will be given orally, once a day, as follows at the discretion of their study doctors: Cycle 1: * Day 1 - 100 mg * Day 2 - 200 mg * Days 3 to 28 - 400 mg Cycle 2: * Participants with a response to the study drugs will continue taking 400 mg from Days 1 to 21, with no study drug from Days 22 to 28 during Cycle 2. * Participants who have not yet responded to the study drugs will continue taking 400 mg from Days 1 to 28 during Cycle 2. Cycle 3 and subsequent cycles: * Participants with a response to the study drugs will continue to take 400 mg from Days 1 to 21, with no study drug from Days 22 to 28. * Participants whose disease has not worsened will continue taking 400 mg from Days 1 to 28. * Participants have not responded to the study drugs will be withdrawn from the study.
- interventionNames
- Drug: Azacitidine
- Drug: Venetoclax
Primary outcomes (3)
- measure
- Proportion of participants achieving complete remission (CR).
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to voluntarily provide written informed consent. * Documented diagnosis per World Health Organization (WHO) 2016 criteria of BCR-ABL negative myeloproliferative neoplasms (MPN). * Documented MPN transformation to accelerated phase (AP) or blast phase (BP) without prior blast reduction therapy for their AP/BP disease. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function. * Must practice at least one reliable method of birth-control starting at least on cycle 1 day 1 until at least 90 days after the last dose of study drug. * Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1. Exclusion Criteria: * History of allogeneic stem cell transplant for MPN. * Previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (HMA). * White blood cell count \>25 x 10\^9/L. * Current enrollment in another interventional study. * Presence of any active uncontrolled infection such as bacterial or fungal infections progressing despite adequate antimicrobial treatment. * Myocardial infarction in the preceding 3 months. * Active human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) infection. * History of active malignancy in the previous 2 years. * Any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation. * Pregnant or breastfeeding women. * Patients with known central nervous system (CNS) involvement with acute myeloid leukemia (AML) or CNS extramedullary hematopoiesis. * Patients with t (15;17) * Patients who have received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment. * Active COVID-19 infection. * History of prior blast-reduction therapy for AP/BP-MPN. * Preceding history MDS, chronic myelomonocytic leukemia (CMML), and other myelodysplastic syndromes (MDS)/MPN overlap syndromes.
References
Publications (0)
Data not yet available
No reference posted for this study.