Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 26, 2018
End Date:July 2021
Contact:Ryan Wilcox, MD, PhD

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Phase I/II Study of Ixazomib and Romidepsin in Relapsed/ Refractory Peripheral T-cell Lymphoma (PTCL)

Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each
cycle is 28 days. Patients will continue to receive therapy until progressive disease,
unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study
includes three dose levels. The phase II study will include treatment with ixazomib and
romidepsin at the MTD established in the Phase I study.

Inclusion Criteria:

- Written informed consent and HIPAA authorization for release of personal health
information. NOTE: HIPAA authorization may be included in the informed consent or
obtained separately.

- Age ≥ 18 years at the time of consent.

- ECOG Performance Status of 0-2 within 14 days prior to registration.

- Histological confirmation of peripheral T-cell lymphoma (PTCL) and biopsy confirmation
of disease relapse (after initial or any subsequent salvage therapy).

- Documented disease progression after receiving at least one prior therapeutic regimen.

- Prior cancer treatment must be completed at least 28 days prior to registration and
the subject must have recovered from all reversible acute toxic effects of the regimen
(other than alopecia) to ≤ Grade 1 or baseline. Systemic steroids at a dose less than
the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are
permitted. Intermittent dexamethasone for the treatment of nausea/emesis is also

- Absolute Neutrophil Count (ANC) ≥ 1000/mm3

- Platelets (Plt) ≥ 75,000/mm3

- Calculated creatinine clearance ≥ 30 cc/min using the Cockcroft-Gault formula

- Bilirubin ≤ 1.5 × upper limit of normal (ULN), (exception of Gilbert disease)

- Aspartate aminotransferase (AST) ≤ 3 × ULN, if known hepatic involvement then ≤ 5 ×

- Alanine aminotransferase (ALT) ≤ 3 × ULN, if known hepatic involvement then ≤ 5 × ULN

- Females of childbearing potential must have a negative serum pregnancy test within 14
days prior to registration. NOTE: Females are considered of child bearing potential
unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least
12 consecutive months.

- Males must be willing to abstain from donating sperm or semen from the time of
informed consent until 90 days after treatment discontinuation.

- The subject must have the ability to understand and comply with study procedures for
the entire length of the study, as determined by the treating physician or protocol

Exclusion Criteria:

- A history of, or a concurrent, clinically significant illness, medical condition or
laboratory abnormality that, in the investigator's opinion, could affect the conduct
of the study.

- Active infection requiring systemic therapy

- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).

- Known additional malignancy that is active and/or progressive requiring treatment;
exceptions include basal cell or squamous cell skin cancer, in situ cervical or
bladder cancer, or other cancer for which the subject has been disease-free for at
least two years.

- Active central nervous system (CNS) lymphoma

- Major surgery or radiation therapy within 28 days of study registration

- Uncontrolled infectious disease, including active herpes simplex or herpes zoster

- Known positive test for Hepatitis B surface antigen, Hepatitis C, or HIV. NOTE:
testing is not required.

- Known GI disease or GI procedure that could interfere with the oral absorption or
tolerance of oral medications including difficulty swallowing, as determined by the
treating physician.

- Evidence of uncontrolled cardiovascular conditions, including uncontrolled
hypertension, cardiac arrhythmias, symptomatic congestive heart failure, unstable
angina, or myocardial infarction within the past 6 months.

- Q-T interval, based on Bazett-corrected interval > 0.45 sec

- Treatment with any investigational drug within 28 days prior to registration.

- Peripheral neuropathy ≥ grade 2

- Prior treatment with bortezomib, ixazomib, or romidepsin.

- Systemic treatment, within 14 days, with strong inhibitors of CYP1A2 (fluvoxamine,
enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin,
itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A
inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital),
or use of St. John's wort.

- Any serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to this protocol.

- Known allergy to any of the study medications, their analogues, or excipients in the
various formulations of any agent.

- Prior autologous hematopoietic stem cell transplant within 90 days of study

- Prior allogeneic hematopoietic stem cell transplant.
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