Phase 2
Completed N=18
Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)
Source: ClinicalTrials.gov NCT01120834 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Overall Response Rate (ORR) — 1 Participants
Summary
This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We also hypothesize that patients demonstrating objective responses to this combination therapy display specific epigenetic signatures, and that a biomarker or gene classifier can be generated which will identify those patients likely to respond.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed diffuse large B cell lymphoma, relapsed after or resistant to prior systemic therapy.
- Subjects must have measurable disease on cross sectional imaging that is at least 1.5 cm in diameter.
- Patients should have relapsed following or be deemed ineligible for autologous stem cell transplantation. There is no limit to number of prior therapies.
- Age > = 18 years.
- ECOG performance status = 1,000/uL
- platelets > = 75,000//uL
- total bilirubin 0.470. Consider discontinuation of medications that prolong QTc interval to eliminate this exclusion if medically appropriate.
- Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
Data sourced from ClinicalTrials.gov (NCT01120834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.