Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
1 other identifier
interventional
29
1 country
11
Brief Summary
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2009
Typical duration for phase_2
11 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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
November 5, 2021
CompletedNovember 5, 2021
October 1, 2021
2.9 years
October 19, 2009
October 7, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as \>= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen.
Up to 24 months
Secondary Outcomes (3)
Duration of Response (DOR)
Up to 24 months
Progression Free Survival (PFS)
Up to 24 months
Overall Survival (OS)
Up to 24 months
Study Arms (1)
Pralatrexate
EXPERIMENTALParticipants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done. Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
Interventions
Pralatrexate injection administered as intravenous (IV) push
1 mg intramuscular (IM) injection
Eligibility Criteria
You may qualify if:
- Histologically/cytologically confirmed, measurable (lesion or node =2 cm by CT \[at least 1 cm if by spiral CT\]) B-cell Non-Hodgkin's Lymphoma, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
- Progressive or persistent disease after ≥ 1 prior treatment(s)
- Recovered from toxic effects of prior treatment
- At least 4 weeks since most recent cytotoxic therapy
- Easter Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate blood, liver, and kidney functions as defined by laboratory levels
- mg/day orally of folic acid for at least 7 days prior \& 1 mg intramuscular of vitamin B12 within 10 weeks of the planned start of pralatrexate
- Females of childbearing potential must agree to use medically acceptable birth control from start of pralatrexate 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
- Males who are not surgically sterile must agree to use medically acceptable birth control from start of pralatrexate until at least 90 days after the last administration of pralatrexate
- Available for repeat dosing and follow-up
- Able to give written informed consent
You may not qualify if:
- Relapsed participants with diffuse large B-cell lymphoma (DLBCL) who are candidates for high-dose therapy and autologous stem cell transplantation (SCT) and for whom high-dose therapy and autologous SCT is a standard curative option
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancies other than those exceptions listed above, the participant must be disease-free for ≥ 5 years. Participants with other prior malignancies \< 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease
- Congestive heart failure Class III/IV according to the New York Heart Association Functional Classification
- Uncontrolled hypertension
- Known human immunodeficiency virus (HIV)-positive diagnosis
- Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Participants who received prophylactic CNS treatment are eligible.
- Participants who have undergone an allogeneic SCT
- Participants who have relapsed \< 100 days from the time of an autologous SCT
- Participants with disease refractory to peripheral blood SCT or who have relapsed \< 100 days from the time of transplant
- Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
- Major surgery within 14 days of enrollment
- Receipt of any conventional chemotherapy or radiation therapy (encompassing a substantial \[\> 10%\] amount of bone marrow) 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 systemic corticosteroids within 1 week of study treatment, unless participant has been taking a continuous dose of no more than 10 mg/day of prednisone or its equivalent 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, 40245, United States
Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101, United States
Frontier Cancer Center and Blood Institute
Billings, Montana, 59102, United States
New York University Hospital
New York, New York, 10016, United States
Providence Cancer Center
Portland, Oregon, 97225, United States
The West Clinic (ACORN)
Memphis, Tennessee, 38120, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53705-2275, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gajanan Bhat, PhD
- Organization
- Spectrum Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 21, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 5, 2021
Results First Posted
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share