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Status:

COMPLETED

Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Lead Sponsor:

Virginia Commonwealth University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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), i...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) for the combination of bortezomib and romidepsin administered weekly x 3 every (q) 4wk in patients with CLL/SLL, indolent B-cell lymp...

Eligibility Criteria

Inclusion

  • 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) allowed

Exclusion

    Key Trial Info

    Start Date :

    April 26 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 13 2018

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00963274

    Start Date

    April 26 2010

    End Date

    April 13 2018

    Last Update

    April 23 2018

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, United States, 60611

    2

    University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, United States, 21201

    3

    University of North Carolina

    Chapel Hill, North Carolina, United States, 27599

    4

    Vanderbilt-Ingram Cancer Center, Vanderbilt University

    Nashville, Tennessee, United States, 37232