Peripheral T Cell LymphomaPhase 4NCT03150602
A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy
A Phase 4 study testing Pralatrexate in people with Peripheral T Cell Lymphoma and Progression, Disease, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 1 site in Taiwan.
Trial summary
This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma, Progression, Disease
- What is being tested?
- Pralatrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2016to 31 Dec 2020
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 20 years of age, inclusive
- Patients with histologically/cytologically confirmed PTCL using either: NCCN diagnosis criteria, the Revised European American Lymphoma (REAL), and World Health Organization (WHO) disease classification (PTCL histology/cytology subtypes diagnosed by site investigators, PTCL histology/cytology subtypes rechecked by study central pathology lab):
- At least 5 patients with Peripheral T-cell lymphoma, NOS
- At least 5 patients with Angioimmunoblastic T-cell lymphoma
- At least 5 patients with Extranodal NK/T-cell lymphoma, nasal type
- Enteropathy-type T-cell lymphoma
Show all 18Show fewer
- Hepatosplenic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
- Patients with documented progressive disease (PD) failed after prior treatment
- Patients may not have received an experimental drug as their only prior therapy
- Patient has had at least 1 biopsy from initial diagnosis of PTCL or in the relapsed setting to confirm PTCL subtypes
- Patient has recovered from the toxic effects of prior therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Adequate hematological, hepatic, and renal function as defined by: absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (and ≥ 50,000/µL for any following dose), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT < 5 X ULN if documented hepatic involvement with lymphoma), creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance ≥ 50 mL/min.
- Women of childbearing potential must agree to practice medically acceptable contraceptive regimen from 30 days prior to study treatment initiation until at least 30 days after the last administration of pralatrexate and must have had a negative serum pregnancy test within 14 days prior to the first day of study treatment. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or were surgically sterilized do not require this test.
- Men who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 90 days after the last administration of pralatrexate.
- Patient has provided written informed consent (IC)
Who cannot join
- Patient has following subtypes (histologically/cytologically confirmed) of PTCL
- Anaplastic large cell lymphoma, ALK +/-
- Patient has: Precursor T/NK neoplasms, with the exception of blastic NK lymphoma
- T-cell prolymphocytic leukemia (T-PLL)
- T-cell large granular lymphocytic leukemia
- Mycosis fungoides and transformed mycosis fungoides
Show all 22Show fewer
- Sézary syndrome
- Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis
- Patient has: Extranodal NK/T-cell lymphoma, nasal type with local recurrence
- Active concurrent malignancy (except for non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years.
- Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure guidelines.
- Patients with human immunodeficiency virus (HIV)-positive diagnosis and are receiving combination anti-retroviral therapy.
- Current or the history of brain metastases or central nervous system (CNS) diseases
- Have undergone allogeneic stem cell transplant
- Relapsed less than 75 days from time of autologous stem cell transplant
- Patients with uncontrolled hypertension, active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to receive protocol treatment
- Had major surgery within 2 weeks of study entry
- Receipt of any conventional chemotherapy or radiation therapy (RT) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study
- Receipt of corticosteroids within 7 days of study treatment, unless patient has been taking a stable dose of no more than 10 mg/day of prednisone for at least 1 month
- Use of any investigational drug, biologic modifier, or device within 4 weeks prior to study treatment or planned use during the course of the study
- Previous exposure to pralatrexate
- Other conditions that investigators consider not suitable for study enrollment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ntional Taiwan University Hospital
Taipei, 100
Bor-Sheng Ko, PhD, 886-23123456 ext. 63576, kevinkomd@gmail.com
Brook Chung, MSc, 886-87297521, brook.chung@mundipharma.com.tw
About this study
Official title: A Multi-Center, Open-Labelled, Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy
This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Read the detailed description
Peripheral T-cell lymphomas (PTCL) are a group of aggressive and diverse lymphoproliferative disorders. It is characterized by the presence of malignant mature T-cells or NK cells. There is as yet no consensus regarding standard frontline or relapsed/refractory therapy for PTCL.
A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed or refractory PTCL, irrespective of age, histological subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. This single-arm, multi-center study aims to evaluate the efficacy and safety of pralatrexate monotherapy in prior treatment failure PTCL patients who may undergo HSCT in case of CR or PR, or continue pralatrexate in case of CR, PR or SD.
Primary objective:
- To evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Secondary objectives:
- To determine the safety of pralatrexate in Asian PTCL patients by,
- Incidence of adverse events (AEs) and serious adverse events (SAEs) emergent from the treatment
- To evaluate the efficacy of pralatrexate in Asian PTCL patients after prior treatment failure by,
- Overall survival (OS), progression-free-survival (PFS), complete response (CR) and partial response (PR) rate, and duration of CR and PR
- Treatment duration with pralatrexate in the patients without hematopoietic stem cell transplant (HSCT) who achieve CR or PR
- Percentage of patients who undergo HSCT
- 1-year OS, 1-year PFS, and 1-year relapse rate after HSCT
- 2-year OS, 2-year PFS, and 2-year relapse rate after HSCT
- Conditions
- Peripheral T Cell Lymphoma, Progression, Disease
- Being tested
- Pralatrexate
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PralatrexateDrug
Also called Folotyn
This is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria.
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate treatment | Experimental | Pralatrexate will initially be administered at a dose of 30 mg/m2/week on days 1, 8, 15, 22, 29 and 36 for 6 weeks in a 7-week cycle (cycle: 6 weeks + 1 week rest). The scheduled date can be done within a window time of plus or minus 1 day Receives: Drug: Pralatrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) to pralatrexate treatment in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Measured: Up to 35 weeks
Secondary outcomes (14)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse events (AE) and serious adverse events (SAE) emergent from the treatment
Measured: Up to 40 weeks
Overall survival
Duration of overall survival (months)
Measured: Up to 5 years
Progression-free survival
Duration of PFS (months)
Measured: Up to 5 years
Completion response rate
The percentage of CR
Measured: Up to 5 years
Partial response rate
The percentage of PR
Measured: Up to 5 years
Duration of CR and PR
Duration of completion response and partial response (days)
Measured: Up to 5 years
Treatment duration
Treatment duration with pralatrexate in the patients without HSCT who achieve CR or PR
Measured: Up to 35 weeks
Hematopoietic stem cell transplant (HSCT)
Percentage of patients who undergo HSCT
Measured: Up to 5 years
1-year OS rate after HSCT
1-year overall survival rate after conducting HSCT
Measured: Up to 1 year
1-year PFS rate after HSCT
1-year progression-free survival rate after conducting HSCT
Measured: Up to 1 year
1-year relapse rate after HSCT
1-year relapse rate after conducting HSCT
Measured: Up to 1 year
2-year OS rate after HSCT
2-year overall survival rate after conducting HSCT
Measured: Up to 2 years
2-year PFS rate after HSCT
2-year progression-free survival rate after conducting HSCT
Measured: Up to 2 years
2-year relapse rate after HSCT
2-year relapse rate after conducting HSCT
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 posted12 May 2017
- Study start30 Aug 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral T 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bor-Sheng Ko, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150602
- Sponsor's protocol ID
- FOT14-TW-401
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18.
PubMed 17512649Shustov A. Novel therapies for peripheral T-cell lymphomas. Ther Adv Hematol. 2013 Jun;4(3):173-87. doi: 10.1177/2040620713481980.
PubMed 23730495Savage KJ, Harris NL, Vose JM, Ullrich F, Jaffe ES, Connors JM, Rimsza L, Pileri SA, Chhanabhai M, Gascoyne RD, Armitage JO, Weisenburger DD; International Peripheral T-Cell Lymphoma Project. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood. 2008 Jun 15;111(12):5496-504. doi: 10.1182/blood-2008-01-134270. Epub 2008 Apr 2.
PubMed 18385450Society TLL, Peripheral T-Cell Lymphoma Facts, 2014.
Wang ES, O'Connor O, She Y, Zelenetz AD, Sirotnak FM, Moore MA. Activity of a novel anti-folate (PDX, 10-propargyl 10-deazaaminopterin) against human lymphoma is superior to methotrexate and correlates with tumor RFC-1 gene expression. Leuk Lymphoma. 2003 Jun;44(6):1027-35. doi: 10.1080/1042819031000077124.
PubMed 12854905Krug LM, Ng KK, Kris MG, Miller VA, Tong W, Heelan RT, Leon L, Leung D, Kelly J, Grant SC, Sirotnak FM. Phase I and pharmacokinetic study of 10-propargyl-10-deazaaminopterin, a new antifolate. Clin Cancer Res. 2000 Sep;6(9):3493-8.
PubMed 10999734O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. doi: 10.1200/JCO.2010.29.9024. Epub 2011 Jan 18.
PubMed 21245435
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Labelled, Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy
- ClinicalTrials.gov ID
- NCT03150602
- Acronym / sponsor ID
- FOT14-TW-401
- Conditions
- Peripheral T Cell Lymphoma, Progression, Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 May 2017 (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 study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Detailed description
Peripheral T-cell lymphomas (PTCL) are a group of aggressive and diverse lymphoproliferative disorders. It is characterized by the presence of malignant mature T-cells or NK cells. There is as yet no consensus regarding standard frontline or relapsed/refractory therapy for PTCL.
A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed or refractory PTCL, irrespective of age, histological subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. This single-arm, multi-center study aims to evaluate the efficacy and safety of pralatrexate monotherapy in prior treatment failure PTCL patients who may undergo HSCT in case of CR or PR, or continue pralatrexate in case of CR, PR or SD.
Primary objective:
- To evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Secondary objectives:
- To determine the safety of pralatrexate in Asian PTCL patients by,
- Incidence of adverse events (AEs) and serious adverse events (SAEs) emergent from the treatment
- To evaluate the efficacy of pralatrexate in Asian PTCL patients after prior treatment failure by,
- Overall survival (OS), progression-free-survival (PFS), complete response (CR) and partial response (PR) rate, and duration of CR and PR
- Treatment duration with pralatrexate in the patients without hematopoietic stem cell transplant (HSCT) who achieve CR or PR
- Percentage of patients who undergo HSCT
- 1-year OS, 1-year PFS, and 1-year relapse rate after HSCT
- 2-year OS, 2-year PFS, and 2-year relapse rate after HSCT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate treatment | Experimental | Drug: PralatrexatePralatrexate will initially be administered at a dose of 30 mg/m2/week on days 1, 8, 15, 22, 29 and 36 for 6 weeks in a 7-week cycle (cycle: 6 weeks + 1 week rest). The scheduled date can be done within a window time of plus or minus 1 day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- At least 20 years of age, inclusive
- Patients with histologically/cytologically confirmed PTCL using either: NCCN diagnosis criteria, the Revised European American Lymphoma (REAL), and World Health Organization (WHO) disease classification (PTCL histology/cytology subtypes diagnosed by site investigators, PTCL histology/cytology subtypes rechecked by study central pathology lab):
- Patients with documented progressive disease (PD) failed after prior treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Adequate hematological, hepatic, and renal function as defined by: absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (and ≥ 50,000/µL for any following dose), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT < 5 X ULN if documented hepatic involvement with lymphoma), creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance ≥ 50 mL/min.
Key exclusion criteria (22 listed)
- Patient has following subtypes (histologically/cytologically confirmed) of PTCL
- Active concurrent malignancy (except for non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years.
- Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure guidelines.
- Patients with human immunodeficiency virus (HIV)-positive diagnosis and are receiving combination anti-retroviral therapy.
- Current or the history of brain metastases or central nervous system (CNS) diseases
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 |
|---|---|---|
| PralatrexateAlso: FolotynThis is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria. | Drug | Pralatrexate treatment |
Primary outcome
Objective Response Rate
Time frame: Up to 35 weeks
Objective response rate (ORR) to pralatrexate treatment in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
14 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 40 weeks
Overall survival
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Completion response rate
Time frame: Up to 5 years
Partial response rate
Time frame: Up to 5 years
Duration of CR and PR
Time frame: Up to 5 years
Treatment duration
Time frame: Up to 35 weeks
Hematopoietic stem cell transplant (HSCT)
Time frame: Up to 5 years
1-year OS rate after HSCT
Time frame: Up to 1 year
1-year PFS rate after HSCT
Time frame: Up to 1 year
1-year relapse rate after HSCT
Time frame: Up to 1 year
2-year OS rate after HSCT
Time frame: Up to 2 years
2-year PFS rate after HSCT
Time frame: Up to 2 years
2-year relapse rate after HSCT
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Background: PubMed 17512649Savage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18.
- Background: PubMed 23730495Shustov A. Novel therapies for peripheral T-cell lymphomas. Ther Adv Hematol. 2013 Jun;4(3):173-87. doi: 10.1177/2040620713481980.
- Background: PubMed 18385450Savage KJ, Harris NL, Vose JM, Ullrich F, Jaffe ES, Connors JM, Rimsza L, Pileri SA, Chhanabhai M, Gascoyne RD, Armitage JO, Weisenburger DD; International Peripheral T-Cell Lymphoma Project. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood. 2008 Jun 15;111(12):5496-504. doi: 10.1182/blood-2008-01-134270. Epub 2008 Apr 2.
- BackgroundSociety TLL, Peripheral T-Cell Lymphoma Facts, 2014.
- Background: PubMed 12854905Wang ES, O'Connor O, She Y, Zelenetz AD, Sirotnak FM, Moore MA. Activity of a novel anti-folate (PDX, 10-propargyl 10-deazaaminopterin) against human lymphoma is superior to methotrexate and correlates with tumor RFC-1 gene expression. Leuk Lymphoma. 2003 Jun;44(6):1027-35. doi: 10.1080/1042819031000077124.
- Background: PubMed 10999734Krug LM, Ng KK, Kris MG, Miller VA, Tong W, Heelan RT, Leon L, Leung D, Kelly J, Grant SC, Sirotnak FM. Phase I and pharmacokinetic study of 10-propargyl-10-deazaaminopterin, a new antifolate. Clin Cancer Res. 2000 Sep;6(9):3493-8.
- Background: PubMed 21245435O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. doi: 10.1200/JCO.2010.29.9024. Epub 2011 Jan 18.
- 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.
Bor-Sheng Ko, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pralatrexate in people with Peripheral T Cell Lymphoma and Progression, Disease, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 1 site in Taiwan.
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 18 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 12 May 2017. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bor-Sheng Ko, PhD (886-23123456 ext. 63576, kevinkomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 35 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150602, which also lists 7 linked publications.
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 12 May 2017.