Clinical trial · Interventional
Study of Carfilzomib and Vorinostat for Relapsed or Refractory Lymphoma
Phase I Trial of Carfilzomib (PR-171) in Combination With Vorinostat (SAHA) in Patients With Relapsed/Refractory B-Cell Lymphomas
- 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 will be a phase I study of carfilzomib in combination with vorinostat in patients with relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171 and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs can also synergize powerfully to induce cell death in bortezomib-resistant cells. The purpose of this study is to see if vorinostat can combine with carfilzomib and to safely find the recommended phase II dose.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: Carfilzomib | Drug | Carfilzomib | ALIAS |
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat + Carfilzomib
- interventionNames
- Drug: Drug: Carfilzomib
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Number of Participants who experience Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- From date of study entry until the 30 days after the last dose of study treatment.
- description
- Determine the recommended phase II doses for the combination of carfilzomib and vorinostat in patients with relapsed or refractory B cell lymphoma.
Secondary outcomes (1)
- measure
- Number of Participants who Respond to Treatment
- timeFrame
- From the date of completion of first cycle of treatment until the date of best response to treatment, as determined by restaging scans
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed B-cell lymphomas, excluding CLL (Chronic Lymphocytic Leukemia), that is recurrent or refractory after at least one prior therapy and for which no other potentially curative therapy is available. * Age ≥ 18 years * ECOG Performance Status (PS) ≤ 2 * Laboratory parameters * if SLL, lymphocyte count \< 5,000/µL * Absolute neutrophil count ≥ 1000/µL * Platelets ≥ 75,000/µL * Creatinine ≤ 1.5x upper limit of normal or calculated creatinine clearance \> 40mL/min * AST, ALT ≤ 2.5 x upper limit of normal (ULN) * Bilirubin ≤ 2.0 mg/mL * Serum potassium ≥ 3.5 mEq/L and serum magnesium ≥ 1.7 mEq/dL (electrolytes may be corrected with supplementation). * PT \< 1.5 x ULN and PTT \< 1.2 x ULN (unless receiving therapeutic anticoagulation). * Patient is, in investigator's opinion, willing and able to comply with the protocol requirements and offers written informed consent. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control ( i.e., oral injectable hormonal methods; barrier methods such as intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence)for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of study. Exclusion Criteria: * History of brain metastasis including leptomeningeal metastasis. * Chemotherapy of radiotherapy within 3 weeks prior to entering the study. * Prior histone deacetylase inhibitor as cancer treatment. * Concurrent treatment with other investigational agents or cancer treatment. * Unable to take oral medications. * Active ischemic heart disease or congestive heart failure. If there is suspicion of cardiac disease, left ventricular ejection fraction (LVEF) must be ≥ 45%, otherwise study to evaluate EF is not required. * Persistent blood pressure (BP) of ≥ 160/95 (three separate readings on different days). * History of allergic reactions attributed to compounds of similar chemical or biological composition to carfilzomib and vorinostat. * Known clinical significant infection including infection with human immunodeficiency virus (HIV), or active hepatitis B or C, requiring treatment. * Serious medical or psychiatric illness likely to interfere with patient participation. * Pregnant or nursing. Confirmation that a woman is not pregnant must be established by a negative serum pregnancy test result obtained at screening. * Pregnancy testing is not required for post-menopausal or surgically sterilized women. * No prior allogeneic stem cell transplant. * Patients scheduled for any type of stem cell transplant within 4 weeks of treatment. * Patients who have valproic acid for epilepsy can enroll, provided that they stopped drug at least 30 days prior to enrollment and they will be on a stable, effective dose of an alternative anti-seizure medication.
References
Publications (0)
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