Clinical trial · Interventional
Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma
Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas
NCT00703664CI-TRIAL-00034175completedPhase 2Results postedClinicalTrials.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 phase II trial studies how well bortezomib and vorinostat work in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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 |
|---|---|---|---|
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, bortezomib)
- description
- Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. Treatment arm consists of 3 cohorts, all receiving the same treatment: A: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. B: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. C: Diffuse Large B-Cell Lymphoma (DLBCL) - with no prior bortezomib.
- interventionNames
- Drug: Bortezomib
- Other: Laboratory Biomarker Analysis
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 9 years
- description
- ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed mantle cell or diffuse large B-cell lymphoma; histological material must be available for central pathological review; unstained histological material -- slides or blocks -- must be available for correlative studies; archived material from previous biopsies is acceptable, unless a patient's lymphoma has been known to undergo histological transformation in the past, in which case a repeat biopsy to confirm histology prior to enrollment is required; availability of material must be confirmed at the time of registration, but material may be submitted subsequent to registration and initiation of study treatment
* Measurable disease according to the Revised Response Criteria for Malignant Lymphoma; this requires at least one lesion greater than 1.0 cm in diameter in both the long and short axis as measured by spiral computed tomography (CT) scan or physical exam
* Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
* \>= 6 months have elapsed since allogeneic transplant
* No graft vs. host disease (GVHD) is present
* Not currently on immunosuppressive therapy
* Prior therapy:
* Mantle cell lymphoma:
* Previously treated or untreated
* No prior bortezomib
* Diffuse large B-cell lymphoma:
* At least one prior systemic therapy
* No prior bortezomib
* Note: Not intended for patients in first relapse who are candidates for high dose therapy with stem cell support
* Life expectancy of greater than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Able to tolerate loperamide or other anti-diarrheal medications
* Absolute neutrophil count \>= 1.5 x 10\^9/L
* Platelets \>= 75 x 10\^9/L
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transferase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
* Creatinine within normal institutional limits or calculated creatinine clearance \>= 60 mL/min according to the Cockcroft-Gault formula
* For patients with known human immunodeficiency virus (HIV) infection, a cluster of differentiation (CD)4 count \>= 0.5 x 10\^9/L
* For patients whose last treatment included bendamustine or fludarabine, a CD4 count \>= 0.4 x 10\^9/L
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and to report pregnancy or suspected pregnancy while participating in the study
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study
* Prior histone deacetylase inhibitor as cancer treatment
* Concurrent treatment with other investigational agents
* Plans for other concurrent cancer treatment; if steroids for cancer control have been used, patients must be off these agents for \>= 1 week before starting treatment; exception: maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose \< 10 mg/day is permitted
* History of brain metastasis including leptomeningeal metastasis
* Grade \>= 2 neuropathy, regardless of cause
* Unable to take oral medications
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or vorinostat
* Not sufficiently recovered from previous treatment
* Medical or other condition (for example: uncontrolled infection; potentially life threatening changes on electrocardiogram \[EKG\]) or concurrent treatment (for example, marrow suppressive agents such as zidovudine) that represents an inappropriate risk to the patient or likely would compromise achievement of the primary study objective; patients should be closely monitored when given bortezomib in combination with the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers
* Pregnant women are excluded from this study; breastfeeding should be discontinued
* Active concurrent malignancy, except adequately treated non-melanoma skin cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.