Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
PROPEL
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
2 other identifiers
interventional
115
6 countries
32
Brief 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 administered to patients with relapsed or refractory PTCL
- Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2006
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 14, 2006
CompletedFirst Posted
Study publicly available on registry
August 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2009
CompletedResults Posted
Study results publicly available
February 1, 2010
CompletedDecember 19, 2019
December 1, 2019
2.4 years
August 14, 2006
October 23, 2009
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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.
Interventions
Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
Eligibility Criteria
You may qualify if:
- 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
- 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.
- +5 more criteria
You may not qualify if:
- 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
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California at Los Angeles
Los Angeles, California, 90095-7077, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Tulane Cancer Center
New Orleans, Louisiana, 70112, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Cliniques Universitaire Saint-Luc
Brussels, 1200, Belgium
Cliniques Universitaires UCL
Yvoir, 5530, Belgium
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHU Henri Mondor
Créteil, 94010, France
CHU DIJON - Hôpital d'enfant
Dijon, 21034, France
CHU Nice - Hôpital de l'Archet 1
Nice, 06202, France
CHU Nantes - Hôtel Dieu
Paris, 44093, France
CHU Saint Louis
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU Robert Debré
Reims, 51092, France
Ospedale Sant'Orsola - Policlinico Sant'Orsola
Bologna, 40138, Italy
St. Georges Hospital
London, SW17 ORE, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Outcome Measure (primary and secondary), Serious Adverse Event and Adverse Event data presented have a cut-off date of August 2009.
Results Point of Contact
- Title
- Michael Saunders, M.D.
- Organization
- Allos Therapeutics, Inc
Study Officials
- STUDY CHAIR
Owen O'Connor, MD, PhD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2006
First Posted
August 16, 2006
Study Start
August 1, 2006
Primary Completion
January 1, 2009
Study Completion
February 24, 2009
Last Updated
December 19, 2019
Results First Posted
February 1, 2010
Record last verified: 2019-12