A Phase 2 interventional study of Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat in Mantle Cell Lymphoma, sponsored by Samsung Medical Center. Terminated at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
Hypothesis
Objectives 1.1 Primary objective • To determine the efficacy of vorinostat plus FND as an induction treatment
Response rate of vorinostat/FND 1.2 Secondary objective
Overall survival and progression-free survival
810 studies on the registry are indexed under Lymphoma, Mantle-Cell; 149 are open to participants now.
This study's enrollment of 20 is below the median of 39 across 718 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histologically proven mantle cell lymphoma
Adequate organ function as defined by the following criteria:
At least one measurable lesion (lymph node or tumor mass)
- The size of lesion must be > 1.0cm in the greatest transverse diameter
Major surgery or radiation therapy within 4 weeks of starting the study treatment.
Vorinostat-fludarabine, mitoxantrone, dexamethasone Induction treatment (Total 4 cycles) FND D1-3 Fludarabine 25mg/m2 + NS 100mL iv over 30 min D1 Mitoxantrone 10mg/m2 + NS 100mL iv over 30 min D1-5 Dexamethasone 20mg IV or PO every 4 weeks Vorinostat D1-10 Vorinostat 200mg once daily PO (When vorinostat is concurrently administered with FND regimen, vorinostat will be administered 3 hours before chemotherapy)
Drug: Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat
Drug pages: Fludarabine · Mitoxantrone · Dexamethasone · Vorinostat
1. Induction treatment (Total 4 cycles) FND D1-3 Fludarabine 25mg/m2 + NS 100mL iv over 30 min D1 Mitoxantrone 10mg/m2 + NS 100mL iv over 30 min D1-5 Dexamethasone 20mg IV or PO every 4 weeks Vorinostat D1-10 Vorinostat 200mg once daily PO (When vorinostat is concurrently administered with FND regimen, vorinostat will be administered 3 hours before chemotherapy) 2. Consolidation treatment for responders Patients not eligible for transplantation * Vorinostat maintenance up to 6 cycles * 200mg twice daily for 14 consecutive days from D1 - 14 in a 21 day cycle * Delay of the start of the next cycle by up to 7 days will be acceptable. * If relapse or progression during maintenance, it will be stopped. Patients eligible for transplantation * High-dose chemotherapy followed by autologous stem cell transplantation
Also known as: 1.Induction treatment (Total 4 cycles) D1-3 Fludarabine D1 Mitoxantrone D1-5 Dexamethasone Vorinostat D1-10 Vorinostat, 2.Consolidation treatment for responders Patients not eligible for transplantation
To determine the efficacy of vorinostat plus FND as an induction treatment confirmed by CT or MRI (PET/CT as indicated)
B) Response criteria 1\) Complete response (CR): Disappearance of all detectable clinical and radiographic evidence of disease 2) Partial response (PR): ≥50% decrease in sum of product diameter (SPD) of 6 nodes/nodal masses 3) Stable disease (SD): Disease status is less than PR, but is not PD 4) Progressive disease (PD): Appearance of any new lesions
Time frame: A) After 8weeks and 16 weeks of the treatment
To determine the efficacy of vorinostat maintenance treatment, survival outcome and toxicity of vorinostat/FND measured by CT or MRI scan, CTCAE ver 4.0
A) Disease status evaluation every 3 months during the 1st two years after enrollment B) Monitoring survival status during the five years after enrollment C) Toxicity evaluation
Time frame: every 3 months during the 1st two years after enrollment
Plan to share: Yes — we will share collected data with principal investigator in Korea
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This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fludarabine · Mitoxantrone · Dexamethasone · Vorinostat