Recurrent Anaplastic Large Cell LymphomaPhase 1NCT04774068
Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
A Phase 1 study testing Parsaclisib and Romidepsin in people with Recurrent Anaplastic Large Cell Lymphoma and Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, run by Walter Hanel at 1 site in United States.
Trial summary
This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Parsaclisib and Romidepsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 27 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age >= 18 years
- Able to understand and voluntarily sign a consent form
- Biopsy proven diagnosis of PTCL or CTCL
- Relapsed/refractory PTCL, progressing after at least one line of systemic therapy (for anaplastic large cell lymphoma [ALCL], must have had prior treatment with brentuximab vedotin). OR
- Relapsed/Refractory CTCL, that progressed on at least 2 lines of skin-directed (topical) therapy and/or one line of systemic therapy. Pre-treatment with mogamulizumab and/or brentuximab vedotin (in the presence of CD30 positive disease) is NOT required as a criterion for eligibility. Skin-directed therapies include, but are not limited to topical steroids, topical chemotherapy, imiquimod, narrow band ultraviolet B (UVB), psoralen plus ultraviolet A photochemotherapy (PUVA), total skin electron beam radiation, and extracorporeal photopheresis
- Mycosis fungoides with large cell transformation is eligible
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- Performance status (Eastern Cooperative Oncology Group [ECOG]) 0-2
- Life expectancy >= 90 days
- Patient must have at least stage IB CTCL (> 10% eBSA) or PTCL with disease defined by a nodal area of at least 1.5 cm in long dimension, extranodal disease of at least 1 cm in long dimension, or fludeoxyglucose F-18 - positron emission tomography (FDG-PET) avid disease (Deauville score = 5)
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Platelet count >= 100,000/mm^3
- Calculated creatinine clearance >= 50mL/min (Cockcroft-Gault method)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN) or =< 5 x ULN if liver involved by lymphoma
- Bilirubin =< 2.0 x ULN. If the subject has Gilbert's disease, low-grade hemolysis, or liver involvement with lymphoma, a bilirubin level of =< 4 x ULN will be allowed
- Negative serum pregnancy test at the time of enrollment for females of childbearing potential
- Women of childbearing potential (as defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months) are required to use a highly effective method of contraception (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants] while on study). Male patients engaged in a sexual relationship with a woman of childbearing potential must agree to use a latex condom during sexual contact, even if he has had a successful vasectomy
- All cancer therapy, including radiation, topical steroid, and chemotherapy must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study. The only exceptions are participants who are symptomatic from their skin lesions and have been on corticosteroids for prolonged periods of time (> 60 days) without change may continue use of either systemic steroids (equivalent to < 10 mg per day of prednisone) or topical steroids are eligible for this study if the frequency and dosage steroids has not changed for 14 days prior to the study
Who cannot join
- Patients with uncontrolled central nervous system (CNS) disease
- Use of immunosuppressive therapy within 28 days of randomization. Immunosuppressive therapy includes, but is not limited to, cyclosporine A, tacrolimus, or high-dose corticosteroids. Participants receiving corticosteroids must be at a dose of =< 10 mg/day prednisone (or equivalent) within 7 days of randomization. However, topical steroids (maximum strength Class III according to World Health Organization Classification of Topical steroids) are allowed to control pruritis
- An active infection requiring a systemic antimicrobial. The patient should be off antibiotic treatment for an active infection for 7 days prior to enrollment in the trial. However, antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to the baseline exam
- Exposure to a live vaccine within 30 days of treatment start
- Positive at the time of screening for human immunodeficiency virus (HIV), hepatitis B surface antigen or viral load, hepatitis C viral load. Hepatitis B (HBV) or hepatitis C (HCV) infection: Participants positive for HBV surface antigen or HBV core antibody will be eligible if they are negative for HBV-deoxyribonucleic acid (DNA); these participants should be considered for prophylactic antiviral therapy. Participants positive for anti-HCV antibody will be eligible if they are negative for HCV ribonucleic acid (RNA)
- Prior malignancy within the past 2 years (allowing squamous cell and basal cell carcinomas with free margins at excision)
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- Prior treatment with a PI3K inhibitor
- Presence of an abnormal electrocardiogram (ECG) that is clinically meaningful. Screening corrected QT interval (QTc) interval > 450 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is > 450 milliseconds, the participant may enroll if the average QTc for 3 ECGs is < 450 milliseconds. If left bundle branch is present, upper limit of QTc will be 550 milliseconds
- Use of strong CYP3A4 inhibitors and inducers. If a CYP3A4 inhibitor was recently used, there should be 14 days or 5 half-lives time (whichever is longer) before the first dose of parsaclisib is administered. Use of moderate CYP3A4 inhibitors are strongly discouraged but not strictly prohibited. If a strong CYP3A4 inhibitor is started after study enrollment, the study principal investigator (PI) should be contacted to discuss alternatives
- Unable to swallow tablets, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of parsaclisib
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Progression while on romidepsin or within 3 months of discontinuation of romidepsin. Prior treatment with romidepsin is allowed if it was well-tolerated
- Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator
- Pregnant or lactating, or intending to become pregnant during the study
- Clinically significant abnormalities in medical history, physical examination, or laboratory values, which in the opinion of the investigator would make the patient unsuitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Phase I Study of Romidepsin in Combination With Parsaclisib in Relapsed and Refractory T-Cell Lymphomas
This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the maximum tolerated dose (MTD) of parsaclisib in combination with romidepsin.
SECONDARY OBJECTIVES:
- To determine the overall response rate (ORR) of parsaclisib in combination with romidepsin in patients with relapsed/refractory primary cutaneous T-cell non-Hodgkin lymphoma / mature T-cell and NK-cell non-Hodgkin lymphoma (CTCL/PTCL).
II. To determine the duration of response (DOR) to treatment. III. Disease control rate (DCR). IV. To determine the progression-free survival (PFS) and overall survival (OS) of parsaclisib in combination with romidepsin in patients with relapsed/refractory CTCL/PTCL.
OUTLINE: This is a dose-escalation study of parsaclisib in the Induction Phase and fixed-dose in the Maintenance phase, and fixed-dose romidepsin in all Phases.
PRE-PHASE: Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Mycosis Fungoides, Refractory Anaplastic Large Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Being tested
- Parsaclisib, Romidepsin
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called (4R)-4-(3-((1S)-1-(4-Amino-3-methyl-1H-pyrazolo(3,4-d)pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one, INCB 50465, INCB-50465, INCB050465
Given PO
RomidepsinDrug
Also called Antibiotic FR 901228, Depsipeptide, FK228, FR901228
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (romidepsin, parsaclisib) | Experimental | PRE-PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Parsaclisib; Drug: Romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of parsaclisib
Will use a time-to-event Bayesian optimal interval design to identify the MTD of this combination regimen.
Measured: Cycles 3-5 (each cycle is 28 days)
Secondary outcomes (5)
Overall response rate (ORR)
ORR defined as the proportion of patients who achieve a complete or partial response among all evaluable patients. The proportion will be provided with a 95% binomial confidence interval. For mature T-Cell and NK-Cell Non-Hodgkin lymphoma (PTCL) patients, response will be evaluated by the Lugano criteria. For primary cutaneous T-Cell Non-Hodgkin lymphoma (CTCL) patients, responses will be evaluated using the Global Response Score. ORR lasting >= 4 months will be captured for CTCL patients.
Measured: Up to 24 weeks
Duration of response (DOR)
DOR defined by time to progression; time from the first romidepsin dose until disease progression.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-free survival (PFS)
PFS will be calculated from the start of the combination treatment to the time of progression or death, whichever occurs first. Will use the method of Kaplan-Meier to describe these survival endpoints; reporting median or estimates at certain time points with 95% confidence intervals.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival (OS)
Will use the method of Kaplan-Meier to describe these survival endpoints; reporting median or estimates at certain time points with 95% confidence intervals.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease control rate (DCR)
DCR is defined as the proportion of patients with complete response, partial response, or stable disease.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Sep 2021
- Primary completion27 Oct 2024
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Anaplastic Large Cell LymphomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Hanel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walter Hanel, Ohio State University Comprehensive Cancer Center
- Investigators
- Walter Hanel, MD, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774068
- Sponsor's protocol ID
- OSU-19264
- Other IDs
- NCI-2021-00728
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2021
- Last updated
- 17 Jan 2025
- Results posted
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Romidepsin in Combination With Parsaclisib in Relapsed and Refractory T-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT04774068
- Acronym / sponsor ID
- OSU-19264
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Mycosis Fungoides, Refractory Anaplastic Large Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Walter HanelUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.
Detailed description
PRIMARY OBJECTIVE:
- To determine the maximum tolerated dose (MTD) of parsaclisib in combination with romidepsin.
SECONDARY OBJECTIVES:
- To determine the overall response rate (ORR) of parsaclisib in combination with romidepsin in patients with relapsed/refractory primary cutaneous T-cell non-Hodgkin lymphoma / mature T-cell and NK-cell non-Hodgkin lymphoma (CTCL/PTCL).
II. To determine the duration of response (DOR) to treatment. III. Disease control rate (DCR). IV. To determine the progression-free survival (PFS) and overall survival (OS) of parsaclisib in combination with romidepsin in patients with relapsed/refractory CTCL/PTCL.
OUTLINE: This is a dose-escalation study of parsaclisib in the Induction Phase and fixed-dose in the Maintenance phase, and fixed-dose romidepsin in all Phases.
PRE-PHASE: Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (romidepsin, parsaclisib) | Experimental | Drug: Parsaclisib, Drug: RomidepsinPRE-PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age >= 18 years
- Able to understand and voluntarily sign a consent form
- Biopsy proven diagnosis of PTCL or CTCL
- Relapsed/refractory PTCL, progressing after at least one line of systemic therapy (for anaplastic large cell lymphoma [ALCL], must have had prior treatment with brentuximab vedotin). OR
- Relapsed/Refractory CTCL, that progressed on at least 2 lines of skin-directed (topical) therapy and/or one line of systemic therapy. Pre-treatment with mogamulizumab and/or brentuximab vedotin (in the presence of CD30 positive disease) is NOT required as a criterion for eligibility. Skin-directed therapies include, but are not limited to topical steroids, topical chemotherapy, imiquimod, narrow band ultraviolet B (UVB), psoralen plus ultraviolet A photochemotherapy (PUVA), total skin electron beam radiation, and extracorporeal photopheresis
Key exclusion criteria (15 listed)
- Patients with uncontrolled central nervous system (CNS) disease
- Use of immunosuppressive therapy within 28 days of randomization. Immunosuppressive therapy includes, but is not limited to, cyclosporine A, tacrolimus, or high-dose corticosteroids. Participants receiving corticosteroids must be at a dose of =< 10 mg/day prednisone (or equivalent) within 7 days of randomization. However, topical steroids (maximum strength Class III according to World Health Organization Classification of Topical steroids) are allowed to control pruritis
- An active infection requiring a systemic antimicrobial. The patient should be off antibiotic treatment for an active infection for 7 days prior to enrollment in the trial. However, antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to the baseline exam
- Exposure to a live vaccine within 30 days of treatment start
- Positive at the time of screening for human immunodeficiency virus (HIV), hepatitis B surface antigen or viral load, hepatitis C viral load. Hepatitis B (HBV) or hepatitis C (HCV) infection: Participants positive for HBV surface antigen or HBV core antibody will be eligible if they are negative for HBV-deoxyribonucleic acid (DNA); these participants should be considered for prophylactic antiviral therapy. Participants positive for anti-HCV antibody will be eligible if they are negative for HCV ribonucleic acid (RNA)
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 |
|---|---|---|
| ParsaclisibAlso: (4R)-4-(3-((1S)-1-(4-Amino-3-methyl-1H-pyrazolo(3,4-d)pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one, INCB 50465, INCB-50465, INCB050465Given PO | Drug | Treatment (romidepsin, parsaclisib) |
| RomidepsinAlso: Antibiotic FR 901228, Depsipeptide, FK228, FR901228Given IV | Drug | Treatment (romidepsin, parsaclisib) |
Primary outcome
Maximum tolerated dose (MTD) of parsaclisib
Time frame: Cycles 3-5 (each cycle is 28 days)
Will use a time-to-event Bayesian optimal interval design to identify the MTD of this combination regimen.
5 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 24 weeks
Duration of response (DOR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease control rate (DCR)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- The JameslineLink provided by the sponsor.
- 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.
Walter Hanel, MD, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parsaclisib and Romidepsin in people with Recurrent Anaplastic Large Cell Lymphoma and Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, run by Walter Hanel at 1 site 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 17 inclusion and 15 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of parsaclisib (time frame: Cycles 3-5 (each cycle is 28 days)). 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 17 Jan 2025.