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Phase 2 Completed N=27 Treatment

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

Source: ClinicalTrials.gov NCT00992446 ↗
Enrolled (actual)
27
Serious AEs
33.3%
Results posted
May 2017
Primary outcomePrimary: Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant — 19 Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant
19
SECONDARY
Median Time to Disease Progression
1.05
SECONDARY
Ability to Complete Planned 12 Cycles of Maintenance Therapy
7; 3; 2; 5; 1; 1
SECONDARY
Overall Survival
16; 3
SECONDARY
Event-free Survival
14; 5

Eligibility Criteria

Inclusion Criteria

  • 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 = 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) = = 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) = grade 2 peripheral neuropathy within 14 days before beginning maintenance therapy
  • Prolonged QTC
  • Poorly-controlled DM
  • Myocardial infarction (MI) with ASCT or developed dilated cardiomyopathy with ASCT
  • Untreated systemic infection
  • Potassium (K) and magnesium (Mg) >= grade 2 toxicity
  • Patie
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00992446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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