Lymphoma, T-Cell, PeripheralPhase 1/2NCT03547700
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
A Phase 1/2 study testing Romidepsin and Ixazomib in people with Lymphoma, T-Cell, Peripheral, run by University of Michigan Rogel Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- Romidepsin and Ixazomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Sep 2018to 27 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 permitted.
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- 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 × ULN
- 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 designee.
Who cannot join
- 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
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- 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 registration.
- Prior allogeneic hematopoietic stem cell transplant.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Illinois Cancer Center
Chicago, Illinois, 60612
Karmanos Cancer Center (Wayne State University)
Detroit, Michigan, 48201
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Minnesota
Minneapolis, Minnesota, 55455
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: 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.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- Romidepsin, Ixazomib
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Also called Istodax
Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
IxazomibDrug
Also called Ninlaro
Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Romidepsin plus Ixazomib | Experimental | The phase I study includes three dose levels (DL) for romidepsin: DL4: 10 mg/m2 on Days 1, 8, 15; DL5: 14 mg/m2 Days 1, 8; DL6: 14 mg/m2 Days 1, 8, 15. Ixazomib is 4 mg PO Days 1, 8, 15. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study. Each cycle is 28 days and patients will receive treatment until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. Receives: Drug: Romidepsin; Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD)
MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled.
The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
Measured: From first dose of treatment through the 1st cycle (28 days)
Phase II: Complete Response Rate (CR)
The complete response (CR) rate of this combination in relapsed/refractory PTCL is defined as complete metabolic response recorded from first day of treatment until disease progression or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Measured: 36 months
Secondary outcomes (4)
Phase II: Overall Response Rate (ORR)
OR, defined as complete or partial metabolic response recorded from first day of treatment until disease progression/recurrence or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Measured: 36 months
Phase II: Duration of Response (DOR)
DOR, defined as time that measurement criteria are met for complete or partial metabolic response (whichever status is recorded first) until disease progression/recurrence or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Measured: 36 months
Phase II: Time To Next Treatment (TTNT)
TTNT defined as the date of initiation of treatment until death or the date of initiation of the next treatment.
Measured: 36 months
Phase II: Overall Survival (OS)
OS, defined as time from first day of treatment to time of death.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start26 Sep 2018
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Big Ten Cancer Research Consortium
- Responsible party
- Sponsor
- Investigators
- Ryan Wilcox, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547700
- Sponsor's protocol ID
- BTCRC-HEM15-028
- Status last verified
- Apr 2026
- First submitted
- 24 May 2018
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Ixazomib and Romidepsin in Relapsed/ Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT03547700
- Acronym / sponsor ID
- BTCRC-HEM15-028
- Conditions
- Lymphoma, T-Cell, Peripheral
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Takeda, Big Ten Cancer Research Consortium
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I: Romidepsin plus Ixazomib | Experimental | Drug: Romidepsin, Drug: IxazomibThe phase I study includes three dose levels (DL) for romidepsin: DL4: 10 mg/m2 on Days 1, 8, 15; DL5: 14 mg/m2 Days 1, 8; DL6: 14 mg/m2 Days 1, 8, 15. Ixazomib is 4 mg PO Days 1, 8, 15. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study. Each cycle is 28 days and patients will receive treatment until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomidepsinAlso: IstodaxRomidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. | Drug | Phase I: Romidepsin plus Ixazomib |
| IxazomibAlso: NinlaroIxazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome. | Drug | Phase I: Romidepsin plus Ixazomib |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD)
Time frame: From first dose of treatment through the 1st cycle (28 days)
MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
Phase II: Complete Response Rate (CR)
Time frame: 36 months
The complete response (CR) rate of this combination in relapsed/refractory PTCL is defined as complete metabolic response recorded from first day of treatment until disease progression or initiation of new antineoplastic therapy, as per the Lugano response criteria.
4 secondary outcomes
Phase II: Overall Response Rate (ORR)
Time frame: 36 months
Phase II: Duration of Response (DOR)
Time frame: 36 months
Phase II: Time To Next Treatment (TTNT)
Time frame: 36 months
Phase II: Overall Survival (OS)
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Wilcox, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Romidepsin and Ixazomib in people with Lymphoma, T-Cell, Peripheral, run by University of Michigan Rogel Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Maximum Tolerated Dose (MTD) (time frame: From first dose of treatment through the 1st cycle (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.