Clinical trial · Interventional
Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Phase I Study of Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, Peripheral T-Cell Lymphoma or Cutaneous T-Cell Lymphoma
- 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 studies the side effects and best dose of giving bortezomib and romidepsin together in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), indolent B-cell lymphoma, peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Bortezomib and romidepsin 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.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Romidepsin | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bortezomib + romidepsin
- description
- Bortezomib via a short intravenous infusion (3-5 seconds) followed by romidepsin via a 4 hour intravenous infusion weekly x 3 every 4 weeks. In order to identify appropriate doses, different subjects will be treated with different drug doses and observed for the effects, especially the side effects associated with higher doses.
- interventionNames
- Drug: Bortezomib
- Drug: Romidepsin
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 2 years
- description
- Dose at which no more than 1 dose-limiting toxicity is observed in as many as 6 patients
Secondary outcomes (1)
- measure
- Pharmacodynamic responses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
\* Diagnosis of 1 of the following:
* CLL or SLL, relapsed or refractory
* Indolent B-cell lymphoma, relapsed or refractory:
* Follicle center lymphoma, follicular or diffuse
* Marginal zone B-cell lymphoma (splenic, nodal, extranodal \[this includes mucosa associated lymphoid tissue (MALT)\])
* Lymphoplasmacytic lymphoma
* PTCL, relapsed or refractory:
* Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-positive
* Anaplastic large cell lymphoma, ALK-negative
* Angioimmunoblastic T-cell lymphoma
* Enteropathy-associated T-cell lymphoma
* Extranodal natural killer (NK)/T-cell lymphoma, nasal type
* Hepatosplenic T-cell lymphoma
* PTCL, not otherwise specified (NOS)
* Subcutaneous panniculitis-like T-cell lymphoma
* CTCL:
\* CTCL with subtypes of mycosis fungoides Stage IB or higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who have failed a previous systemic treatment, as per the following:
* Stage IA plaque, IB, or IIA: At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light \[PUVA\] and systemic corticosteroids)
* Stage IIB, III, or IV: At least 1 prior systemic regimen (systemic corticosteroids alone or PUVA alone do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered 1 regimen
* 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
* No prior or concurrent CNS malignancy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* ANC \> 1,500/mm\^3
* Platelet count \> 75,000/mm\^3
* Hemoglobin \> 7.5 g/dL (transfusion allowed)
* Serum creatinine ≤ 1.2 mg/dL or actual or calculated creatinine clearance \> 60 mL/min
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ ULN
* Serum potassium ≥ 3.5 mEq/L (supplementation allowed)
* Serum magnesium ≥ 1.7 mEq/L (supplementation allowed)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
* Willing and able to comply with protocol requirements
* No prior severe allergic reactions to bortezomib, boron, mannitol, or romidepsin
* No progressing toxicity secondary to bortezomib
* No grade 1 peripheral neuropathy with pain or ≥ grade 2 peripheral neuropathy by NCI-CTCAE criteria (v4.0) within the past 14 days
* No condition related to ischemic heart disease, heart failure, or the risk of torsades de pointes or sudden cardiac death, including any of the following:
* History of sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, or resuscitated cardiac arrest unless currently addressed with an implantable cardiac defibrillator
* Baseline heart rate \> 140 beats per minute
* Known congenital long QT syndrome
* QTc interval \> 480 milliseconds
* Type II second-degree atrio-ventricular (AV) block, third-degree AV block, or ventricular rate \< 50 beats per minute
* Myocardial infarction within the past 6 months
* Patients who have had a myocardial infarction 6-12 months ago are eligible provided they are asymptomatic and have a negative cardiac risk assessment (i.e., treadmill stress test, nuclear medicine stress test, or stress echocardiogram)
* Angina upon ordinary physical activity
* Angina only with strenuous, rapid, or prolonged exertion allowed
* ECG with evidence of cardiac ischemia, as defined by the following:
* ST depression of ≥ 2 mm, measured from isoelectric line to ST segment
* T-wave inversion ≥ 4 mm, measured from isoelectric line to peak of T-wave
* NYHA class II-IV congestive heart failure
* Known left ventricular ejection fraction \< 40% by MUGA scan or \< 50% by echocardiogram or MRI
* Known hypertrophic cardiomegaly or restrictive cardiomyopathy
* No uncontrolled hypertension, defined as persistent blood pressure ≥ 160/95 mm Hg despite medical management
* No clinically significant active infection, including known HIV infection or hepatitis B or C
* No other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
* No concurrent medical condition that, in the investigator's opinion, would compromise study treatment or assessment of toxicity
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy, radiation therapy or investigational agents. If steroids for cancer control have been used, patients must be off theses agents for at least 1 week before starting treatment. (Maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose less than 10 mg/day is permitted)
* Prior allogeneic stem cell transplantation allowed provided all of the following conditions are met:
* Greater than or equal to 6 months have elapsed since allogeneic transplant
* No Graft vs. Host Disease (GVHD) is present
* More than 4 weeks since prior bortezomib
* No concurrent oral hormonal contraceptives
* No concurrent potent or moderate CYP3A4 inhibitors
* No concurrent anti-arrhythmic agents
* No concurrent treatment with any drugs that are generally accepted to having a risk of causing torsades de pointes (class 1 drugs)
* Class 2 or 3 drugs allowed at the discretion of the investigator
* No other concurrent systemic therapy for the malignancy
* Concurrent warfarin (coumadin) allowedReferences
Publications (1)
- RESULTHolkova B, Yazbeck V, Kmieciak M, Bose P, Ma S, Kimball A, Tombes MB, Shrader E, Wan W, Weir-Wiggins C, Singh A, Hogan KT, Conine S, Sankala H, Roberts JD, Shea TC, Grant S. A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leuk Lymphoma. 2017 Jun;58(6):1349-1357. doi: 10.1080/10428194.2016.1276287. Epub 2017 Jan 19. PMID 28103725