Clinical trial · Interventional
Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Phase I Trial of Vorinostat (SAHA) in Combination With Alvocidib (Flavopiridol) in Patients With Relapsed, Refractory, or (Selected) Poor Prognosis Acute Leukemia or Refractory Anemia With Excess Blasts-2
- 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 phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Refractory Anemia With Excess Blasts | Myelodysplastic Syndrome with Excess Blasts | ALIAS | 0.90 |
| Relapsing Chronic Myelogenous Leukemia | — | UNRESOLVED | — |
| Untreated Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Untreated Adult Acute Myeloid Leukemia |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients will receive a 1-hour infusion of flavopiridol on 5 days in week 1 and vorinostat by mouth three times a day in weeks 1 and 2. Treatment may repeat every 3 weeks for as long as benefit is shown.
- interventionNames
- Drug: alvocidib
- Drug: vorinostat
Primary outcomes (1)
- measure
- MTD for the combination of alvocidib and vorinostat, assessed by Common Toxicity Criteria version 3.0
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of one of the following: * Relapsed or refractory acute leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or acute leukemia unclassifiable) following at least one prior systemic treatment * Acute leukemia in a patient 60 years or older (no requirement for prior treatment) * Acute leukemia that has evolved from a prior myelodysplastic syndrome * Chronic myelogenous leukemia (CML) in blast crisis following prior imatinib mesylate therapy * Refractory anemia with excess blasts-2 (RAEB-2) * No known CNS leukemia * ECOG performance status 0-2 * WBC \< 50,000µL * Hydroxyurea and/or leukaphereses may be used to lower WBC * Creatinine =\< 1.5 times upper limit of normal (ULN) OR creatinine clearance \>= 50 mL/min * Total bilirubin =\< 2 times ULN * AST/ALT =\< 2.5 times ULN * QTc interval =\< 0.470 seconds * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No other condition that would preclude study participation * At least 3 weeks since prior treatment (expect leukaphereses) * No valproic acid therapy within the past 2 weeks * No prior autologous or allogeneic bone marrow or stem cell transplantation * No hydroxyurea use within the past 24 hours * No concurrent treatment with other anti-cancer agents or investigational agents
References
Publications (0)
Data not yet available