Peripheral T-cell LymphomaPhase 1/2NCT02013362
Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 1/2 study testing Pralatrexate injection, Vitamin B12 and Folic Acid in people with Peripheral T-cell Lymphoma, run by Mundipharma K.K. at 3 sites in Japan.
Trial summary
Phase I portion: To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Pralatrexate injection, Vitamin B12 and Folic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesJapan
- Study dates
- Mar 2014to Sep 2017
- Phase
- Phase 1/2
- 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
- Japanese patients at least 20 years of age.
- Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
- Relapsed or refractory patients with a treatment history of at least one regimen.
- Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
- Patients expected to survive for at least 3 months.
- ECOG PS 0-2.
- Patients with adequate hemopoietic efficacy, liver and kidney function.
- Patients from whom written consent has been obtained prior to study initiation.
Who cannot join
- Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
- Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
- Patients who received another study drug within 28 days prior to initial administration of the study drug.
- Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
- Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
- Patients with cerebral metastasis or central nervous system lesion or a past history.
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- Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
- Patients with severe cardiovascular disease.
- Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
- Patients positive for CMV antigen on immunological investigation.
- Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
- Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
National Cancer Center Hospital
Chūō, Tokyo, 104-0045
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Okayama University Hospital
Okayama, 700-8558
About this study
Phase I portion:
To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics.
Phase II portion:
To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Pralatrexate injection, Vitamin B12, Folic Acid
- 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.
Pralatrexate injectionDrug
Vitamin B12Dietary supplement
Folic AcidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate injection | Experimental | Dietary Supplement: Vitamin B12, Folic Acid Receives: Drug: Pralatrexate injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) per independent central review committee
The ORR is defined as the proportion of patients with complete response (CR) and partial response (PR). Response will be determined according to International Workshop Criteria (IWC). Assessments will be done at week 7 (end of Cycle 1), subsequently every 14 weeks (end of odd-numbered cycle).
Measured: From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kensei Tobinai, MD,PhD, Principal investigator, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013362
- Sponsor's protocol ID
- PDX-JP1
- Status last verified
- Nov 2017
- First submitted
- 4 Dec 2013
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maruyama D, Nagai H, Maeda Y, Nakane T, Shimoyama T, Nakazato T, Sakai R, Ishikawa T, Izutsu K, Ueda R, Tobinai K. Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Sci. 2017 Oct;108(10):2061-2068. doi: 10.1111/cas.13340. Epub 2017 Sep 4.
PubMed 28771889
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02013362
- Acronym / sponsor ID
- PDX-JP1
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mundipharma K.K.Industry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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.
Phase I portion:
To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics.
Phase II portion:
To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate injection | Experimental | Drug: Pralatrexate injection, Dietary Supplement: Vitamin B12, Dietary Supplement: Folic AcidDietary Supplement: Vitamin B12, Folic Acid |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Japanese patients at least 20 years of age.
- Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
- Relapsed or refractory patients with a treatment history of at least one regimen.
- Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
- Patients expected to survive for at least 3 months.
Key exclusion criteria (12 listed)
- Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
- Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
- Patients who received another study drug within 28 days prior to initial administration of the study drug.
- Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
- Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
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 |
|---|---|---|
| Pralatrexate injection | Drug | Pralatrexate injection |
| Vitamin B12 | Dietary supplement | Pralatrexate injection |
| Folic Acid | Dietary supplement | Pralatrexate injection |
Primary outcome
Objective response rate (ORR) per independent central review committee
Time frame: From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.
The ORR is defined as the proportion of patients with complete response (CR) and partial response (PR). Response will be determined according to International Workshop Criteria (IWC). Assessments will be done at week 7 (end of Cycle 1), subsequently every 14 weeks (end of odd-numbered cycle).
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 9 Nov 2017.
- Derived from this study: PubMed 28771889Maruyama D, Nagai H, Maeda Y, Nakane T, Shimoyama T, Nakazato T, Sakai R, Ishikawa T, Izutsu K, Ueda R, Tobinai K. Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Sci. 2017 Oct;108(10):2061-2068. doi: 10.1111/cas.13340. Epub 2017 Sep 4.
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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.
Kensei Tobinai, MD,PhD principal investigator
National Cancer Center Hospital
3 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 Pralatrexate injection, Vitamin B12 and Folic Acid in people with Peripheral T-cell Lymphoma, run by Mundipharma K.K. at 3 sites in Japan.
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 8 inclusion and 12 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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?
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?
Objective response rate (ORR) per independent central review committee (time frame: From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.). 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 NCT02013362, which also lists 1 linked publication.
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 9 Nov 2017.