Peripheral T-cell LymphomaPhase 2PROPELNCT00364923
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 2 study testing Pralatrexate Injection in people with Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 32 sites in 6 countries.
Trial summary
Primary Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Pralatrexate Injection
- Type of treatment
- Injection or infusion
- How many people
- 115 participants
- Where
- 32 sitesin 6 countries
- Study dates
- Aug 2006to 24 Feb 2009
- Phase
- Phase 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
- Histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification:
- T/Natural Killer (T/NK) cell leukemia/lymphoma
- Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
- Angioimmunoblastic T cell lymphoma
- Blastic Natural Killer (NK) lymphoma (with skin, lymph node, or visceral involvement)
- Anaplastic large cell lymphoma, primary systemic type
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- PTCL - unspecified
- T/NK-cell lymphoma - nasal
- Enteropathy-type intestinal lymphoma
- Hepatosplenic T cell lymphoma
- Extranodal peripheral T/NK-cell lymphoma - unspecified
- Subcutaneous panniculitis T-cell lymphoma
- Transformed mycosis fungoides
- Documented progression of disease after at least 1 prior treatment. Patients may not have received experimental therapy as their only prior therapy. Patient has at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm the diagnosis of PTCL. Patient has recovered from the toxic effects of prior therapy. Patients treated with monoclonal antibody therapy may be enrolled regardless of the time frame of the therapy if they have progression of disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- ≥ 18 years of age.
- Adequate hematological, hepatic, and renal function.
- Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate and must have 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 or are 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 given written informed consent.
Who cannot join
- 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, other than transformed mycosis fungoides
- Sézary syndrome
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- Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis
- Active concurrent malignancy (except 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 greater than or equal to 5 years.
- Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure Guidelines.
- Uncontrolled hypertension.
- Human immunodeficiency virus (HIV)-positive diagnosis and is receiving combination anti-retroviral therapy.
- Patient has, or history of, brain metastases or central nervous system (CNS) disease.
- Patient has undergone an allogeneic stem cell transplant.
- Patient has relapsed less than 75 days from time of an autologous stem cell transplant.
- 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.
- 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 continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
- Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study.
- Previous exposure to pralatrexate.
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States18 sites
Emory University
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago Hospital
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
UT MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Nevada Cancer Institute
Las Vegas, Nevada, 89135
University of California at Los Angeles
Los Angeles, California, 90095-7077
Yale University School of Medicine
New Haven, Connecticut, 06520
Tulane Cancer Center
New Orleans, Louisiana, 70112
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Presbyterian Hospital
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Rochester Cancer Center
Rochester, New York, 14642
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
France7 sites
CHU Henri Mondor
Créteil, 94010
CHU DIJON - Hôpital d'enfant
Dijon, 21034
CHU Nice - Hôpital de l'Archet 1
Nice, 06202
CHU Nantes - Hôtel Dieu
Paris, 44093
CHU Saint Louis
Paris, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU Robert Debré
Reims, 51092
Belgium2 sites
Cliniques Universitaire Saint-Luc
Brussels, 1200
Cliniques Universitaires UCL
Yvoir, 5530
Canada2 sites
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
United Kingdom2 sites
St. Georges Hospital
London, SW17 ORE
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Primary
- Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
Secondary
- Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
- Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Read the detailed description
This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.
Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Pralatrexate Injection
- Keywords
- Peripheral T-cell Lymphoma, T-cell Lymphoma, Lymphoma, PDX, Pralatrexate, Vitamin B12, Folic acid
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pralatrexate InjectionDrug
Also called FOLOTYN, Pralatrexate, Pralatrexate Solution for Infusion, (RS)-10-propargyl-10-deazaaminopterin
Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate Per Independent Central Review
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
Measured: Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Secondary outcomes (3)
Duration of Response Per Independent Central Review
Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.
Measured: Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Progression-free Survival Per Independent Central Review
Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.
Measured: Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose
Overall Survival Per Independent Central Review
Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.
Measured: Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2009
- Study completion24 Feb 2009
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 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Owen O'Connor, MD, PhD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364923
- Sponsor's protocol ID
- PDX-008
- Other IDs
- 2006-002811-29
- Acronym
- PROPEL
- Status last verified
- Dec 2019
- First submitted
- 14 Aug 2006
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00364923
- Acronym / sponsor ID
- PROPEL / PDX-008
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Peripheral T-cell Lymphoma, T-cell Lymphoma, Lymphoma, PDX, Pralatrexate, Vitamin B12, Folic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- 24 Feb 2009 (actual)
- First posted
- 16 Aug 2006 (estimated)
- Results
- Posted 1 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary
- Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
Secondary
- Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
- Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Detailed description
This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.
Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification:
- Documented progression of disease after at least 1 prior treatment. Patients may not have received experimental therapy as their only prior therapy. Patient has at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm the diagnosis of PTCL. Patient has recovered from the toxic effects of prior therapy. Patients treated with monoclonal antibody therapy may be enrolled regardless of the time frame of the therapy if they have progression of disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- ≥ 18 years of age.
- Adequate hematological, hepatic, and renal function.
Key exclusion criteria (20 listed)
- Patient has:
- Active concurrent malignancy (except 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 greater than or equal to 5 years.
- Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure Guidelines.
- Uncontrolled hypertension.
- Human immunodeficiency virus (HIV)-positive diagnosis and is receiving combination anti-retroviral therapy.
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 InjectionAlso: FOLOTYN, Pralatrexate, Pralatrexate Solution for Infusion, (RS)-10-propargyl-10-deazaaminopterinPralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle. | Drug | – |
Primary outcome
Response Rate Per Independent Central Review
Time frame: Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
3 secondary outcomes
Duration of Response Per Independent Central Review
Time frame: Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Progression-free Survival Per Independent Central Review
Time frame: Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose
Overall Survival Per Independent Central Review
Time frame: Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Owen O'Connor, MD, PhD study chair
Columbia University
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pralatrexate Injection in people with Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 32 sites in 6 countries.
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 20 inclusion and 20 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Belgium, Canada, United Kingdom and 1 more country. 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 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 1 Feb 2010). 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?
Response Rate Per Independent Central Review (time frame: Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose). 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 19 Dec 2019.