Lymphoma Clinical Trial
Official title:
A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax®) in Combination With Doxorubicin HCl Liposomal (Doxil®) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma
This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best response, 8 cycles, disease progression or intolerability whichever comes first. Importantly, doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed until disease progression or death whichever comes first.
This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy
study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in
combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or
refractory cutaneous T-cell lymphoma after at least one prior line of systemic therapy.
STUDY ENDPOINTS:
Primary:
MTD will be determined by standard "3+3" dose escalation of romidepsin with a fixed dose of
doxorubicin HCl liposomal. Participants will be followed throughout therapy and all adverse
events recorded, graded, and given likelihood of relevance to study therapies. Toxicity will
be graded by the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Secondary:
- Response will be assessed by a global response score integrating change in skin disease
as measured by the modified severity-weighted assessment tool (mSWAT) score, change in
lymph node size, change in visceral disease, and changes in peripheral blood Sézary
cells by flow cytometry. CR/PR assignment requires confirmatory assessment in 4 weeks.
Skin scores, clinical lymph node, liver and spleen exam, and Sézary cell count
assessment will occur on Day 1 of each cycle. Contrasted CT scan of the neck, chest,
abdomen and pelvis will be performed at screening for all patients. In patients with
lymphadenopathy and/or organomegaly at screening, contrasted CT scans of the neck,
chest, abdomen, and pelvis will occur at the end of every third cycle of therapy, within
1 week of cycle 8 completion, and every 6 months for one year after maximal response.
All patients will have contrasted CT scans of the neck, chest, abdomen, and pelvis at
the time of concern for disease progression in lymph nodes and/or viscera.TTR is the
time of the first romidepsin dose to the time of documented objective response (PR/CR).
DOR is the time from first objective response (PR or CR) until disease progression.
- TTP will be measured from the time of the first romidepsin dose until disease
progression.
- Pruritus will be assessed monthly using a 100 mm visual analog scale. Quality of life
will be assessed monthly by Functional Assessment of Cancer Therapy- General (FACT-G),
Skindex-29, and ItchyQOL questionnaires.
Exploratory:
Skin lesions will be punch biopsied (two contiguous 5mm biopsies) prior to beginning therapy
as standard care of care. Any leftover tissue will be collected for research with consent of
patient. Optional single 5mm punch biopsies will be obtained on day 15 of Cycle 2 after
infusion of romidepsin, and at disease relapse.
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