Clinical trial · Interventional
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT01211457CI-TRIAL-00039506unknownPhase 1 / Phase 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)
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sapacitabine and decitabine (Part 1 - completed) | Drug | — | UNRESOLVED |
| sapacitabine and venetoclax (Part 2 - recruiting) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sapacitabine/decitabine (Part 1 - completed)
- description
- decitabine will be administered in alternating cycles with sapacitabine
- interventionNames
- Drug: sapacitabine and decitabine (Part 1 - completed)
- type
- EXPERIMENTAL
- label
- sapacitabine/venetoclax (Part 2 - recruiting)
- description
- sapacitabine will be administered concomitantly with venetoclax
- interventionNames
- Drug: sapacitabine and venetoclax (Part 2 - recruiting)
Primary outcomes (1)
- measure
- Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2) * Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2) * ECOG performance status 0-2 * Adequate renal function * Adequate liver function * Able to swallow capsules * Ability to understand and willingness to sign the informed consent form Exclusion Criteria: * AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement * Known central nervous system (CNS) involvement by leukemia * Uncontrolled intercurrent illness including * Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2) * Known to be HIV-positive
References
Publications (1)
- RESULTPooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.