Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Adult Diffuse Large B-Cell Lymphoma, B-Cell Non-Hodgkin Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Non-Hodgkin Lymphoma

In brief

This phase II trial studies the side effects and how well bortezomib and vorinostat work in treating patients with non-Hodgkin lymphoma (NHL) after patients' own stem cell (autologous) transplant. Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells and make them more likely to die by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus kill lymphoma cells that remain after transplant.

Key facts

Study ID: NCT00992446
Run by: Fred Hutchinson Cancer Center
People needed: 27
Starts: 2010-09-02
Expected to finish: 2019-10-29
Last updated by the study team: 2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

INCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
Diagnosis of non-Hodgkin's lymphoma, transformed B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell or T-cell lymphoma, and deemed a candidate for autologous transplant
American Heart Association class I: patients with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; additionally, patients > 60 years of age must have a left ventricular ejection fraction of at least >= 40% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram (Echo)
Total bilirubin =< 1.5 mg/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x the upper limit of normal
Creatinine clearance (CrCL) (calculated creatinine clearance is permitted) > 40 mL/min
Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) >= 50% of predicted (corrected for hemoglobin)
Autologous graft with a minimum of >= 3.0 x 10\^6 CD34+ cells/kg; not CD34 selected
Signed informed consent
Female patients of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (hCG)
Female patient is either postmenopausal, free from menses for >= 2 years, surgically sterilized, or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study
Male patient agrees to use an adequate method of contraception for the duration of the study
INCLUSION CRITERIA FOR MAINTENANCE THERAPY
30-120 days post ASCT for non-Hodgkin's lymphoma
CrCL >= 40 ml/min
Platelets (PLT) >= 75,000 cells/mm\^3 for 5 days after recovery from ASCT nadir
Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 for 5 days after recovery from ASCT nadir
Total bilirubin (TB) =< 1.5 x upper limit of normal (ULN)
AST/ALT =< 2.5 x ULN

You may not qualify if…

EXCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
Karnofsky performance score < 70%
Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
Pregnant or breastfeeding
Fertile men and women unwilling to use contraceptive techniques from the time of transplant until one month post maintenance therapy
Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Patients with evidence of myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) or abnormal cytogenetics analysis indicative of MDS on the pre-transplant bone marrow examination
Prolonged corrected QT interval (QTC) on electrocardiogram (EKG)
Poorly-controlled diabetes mellitus (DM)
>= grade 2 peripheral neuropathy
Prior history of human immunodeficiency virus (HIV) positivity or known history of hepatitis B or C
Previous history of hypersensitivity to bortezomib, boron, or mannitol; known hypersensitivity to the components of study drug or its analogs
Require therapeutic anticoagulation treatment, especially with Coumadin
Patient who has had chemotherapy, radiotherapy, or biological therapy, within 30 days (42 days for nitrosoureas or mitomycin C) or who has not recovered from adverse events due to agents administered more than 30 days earlier
Patient is currently participating or has participated in a study with an investigational compound or devise within 30 days of initial dosing with study drug(s)
Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidepsin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat [PXD-101], LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period
History of central nervous system (CNS) disease
Symptomatic ascites or pleural effusions
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
Patient with a history of a prior malignancy with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma or an in situ malignancy; adequately treated localized prostate carcinoma with prostate-specific antigen (PSA) < 1.0; or who has undergone potentially curative therapy with no evidence of disease for five years, and/or who is deemed at low risk for recurrence by his/her treating physician
Patient has a history or current evidence of any condition, therapy, or laboratory (lab) abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate
Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs
EXCLUSION CRITERIA FOR MAINTENANCE THERAPY
>= grade 2 peripheral neuropathy within 14 days before beginning maintenance therapy

Where it is running

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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