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Trial record 4 of 18 for:    pralatrexate AND Vitamin B

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PROPEL)

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ClinicalTrials.gov Identifier: NCT00364923
Recruitment Status : Completed
First Posted : August 16, 2006
Results First Posted : February 1, 2010
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral T-cell Lymphoma
Intervention Drug: Pralatrexate Injection
Enrollment 115
Recruitment Details Patients were enrolled between 24 August 2006 and 14 April 2008 across 25 study sites, 15 sites in the United States (US), 8 in Europe, and 2 in Canada.
Pre-assignment Details Patients (pts) were required to have at least 10 days of vitamin supplementation during the up to 12 days between enrollment & dosing. Four of the 115 pts enrolled were excluded during this period: 2 did not have an eligible PTCL subtype per central review, 1 had the presence of B-cell lymphoma per the investigator, 1 had progressive disease.
Arm/Group Title Full Population
Hide Arm/Group Description All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
Period Title: Treatment With Pralatrexate
Started 111 [1]
Completed 107 [2]
Not Completed 4
Reason Not Completed
Treatment with pralatrexate ongoing             4
[1]
Received at least one dose of pralatrexate.
[2]
Treatment duration not limited. After treatment ends, patients attend survival follow-up visits.
Period Title: Survival Follow-up, After Pralatrexate
Started 107 [1]
Completed 83 [2]
Not Completed 24
Reason Not Completed
Pts still in follow-up at data cutoff             24
[1]
Patients (pts) who stop treatment with pralatrexate are followed for survival
[2]
Pts who completed follow-up either died, were followed for 24 months, or withdrew
Arm/Group Title Full Population
Hide Arm/Group Description All patients who received at least one dose of pralatrexate
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
<=18 years
0
   0.0%
Between 18 and 65 years
71
  64.0%
>=65 years
40
  36.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
57.7  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
35
  31.5%
Male
76
  68.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants
United States 76
Canada 9
Europe 26
1.Primary Outcome
Title Response Rate Per Independent Central Review
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: of Patients who Responded
32
2.Secondary Outcome
Title Duration of Response Per Independent Central Review
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
Overall Number of Participants Analyzed 32
Median (Full Range)
Unit of Measure: Days
306
(1 to 673)
3.Secondary Outcome
Title Progression-free Survival Per Independent Central Review
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
Overall Number of Participants Analyzed 109
Median (Full Range)
Unit of Measure: Days
106
(1 to 726)
4.Secondary Outcome
Title Overall Survival Per Independent Central Review
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
Overall Number of Participants Analyzed 109
Median (Full Range)
Unit of Measure: Months
14.5
(1 to 24.1)
Time Frame All adverse events (AEs) were captured from the first dose of pralatrexate through 30 days after the last study treatment. From 31 days after the last dose of pralatrexate, pralatrexate-related AEs were recorded until the start of subsequent therapy.
Adverse Event Reporting Description Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.
 
Arm/Group Title Full Population
Hide Arm/Group Description All patients who received at least one dose of pralatrexate
All-Cause Mortality
Full Population
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Full Population
Affected / at Risk (%)
Total   50/111 (45.05%) 
Blood and lymphatic system disorders   
febrile neutropenia  1  5/111 (4.50%) 
neutropenia  1  3/111 (2.70%) 
thrombocytopenia  1  3/111 (2.70%) 
lymph node pain  1  1/111 (0.90%) 
pancytopenia  1  1/111 (0.90%) 
Cardiac disorders   
atrial fibrillation  1  1/111 (0.90%) 
cardiorespiratory arrest  1  1/111 (0.90%) 
pericardial effusion  1  1/111 (0.90%) 
ventricular tachycardia  1  1/111 (0.90%) 
Endocrine disorders   
inappropriate antidiuretic hormone secretion  1  1/111 (0.90%) 
Gastrointestinal disorders   
stomatitis  1  5/111 (4.50%) 
abdominal pain  1  2/111 (1.80%) 
nausea  1  1/111 (0.90%) 
obstruction gastric  1  1/111 (0.90%) 
esophagitis  1  1/111 (0.90%) 
perianal erythema  1  1/111 (0.90%) 
polyp colorectal  1  1/111 (0.90%) 
vomiting  1  1/111 (0.90%) 
General disorders   
pyrexia  1  8/111 (7.21%) 
fatigue  1  2/111 (1.80%) 
mucosal inflammation  1  1/111 (0.90%) 
pain  1  1/111 (0.90%) 
Hepatobiliary disorders   
cholecystitis acute  1  1/111 (0.90%) 
Infections and infestations   
sepsis  1  5/111 (4.50%) 
herpes zoster  1  3/111 (2.70%) 
pneumonia  1  3/111 (2.70%) 
urinary tract infection  1  2/111 (1.80%) 
candidiasis  1  1/111 (0.90%) 
catheter site infection  1  1/111 (0.90%) 
cytomegalovirus colitis  1  1/111 (0.90%) 
infection  1  1/111 (0.90%) 
septic shock  1  1/111 (0.90%) 
sinusitis  1  1/111 (0.90%) 
upper respiratory tract infection  1  1/111 (0.90%) 
wound infection  1  1/111 (0.90%) 
Injury, poisoning and procedural complications   
excoriation  1  1/111 (0.90%) 
Metabolism and nutrition disorders   
dehydration  1  4/111 (3.60%) 
hypercalcemia  1  1/111 (0.90%) 
hypomagnesemia  1  1/111 (0.90%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
bile duct cancer  1  1/111 (0.90%) 
tumor associated fever  1  1/111 (0.90%) 
tumor lysis syndrome  1  1/111 (0.90%) 
Nervous system disorders   
cerebral infarction  1  2/111 (1.80%) 
carotid sinus syndrome  1  1/111 (0.90%) 
convulsion  1  1/111 (0.90%) 
ischemic stroke  1  1/111 (0.90%) 
Renal and urinary disorders   
renal failure actue  1  2/111 (1.80%) 
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  4/111 (3.60%) 
epistaxis  1  1/111 (0.90%) 
pneumonitis  1  1/111 (0.90%) 
pulmonary embolism  1  1/111 (0.90%) 
Skin and subcutaneous tissue disorders   
skin ulcer  1  2/111 (1.80%) 
Vascular disorders   
hypotension  1  2/111 (1.80%) 
subclavian vein thrombosis  1  1/111 (0.90%) 
superior vena caval occlusion  1  1/111 (0.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Full Population
Affected / at Risk (%)
Total   111/111 (100.00%) 
Blood and lymphatic system disorders   
thrombocytopenia  1  33/111 (29.73%) 
anemia  1  32/111 (28.83%) 
neutropenia  1  22/111 (19.82%) 
Cardiac disorders   
tachycardia  1  11/111 (9.91%) 
Eye disorders   
eye irritation  1  7/111 (6.31%) 
Gastrointestinal disorders   
stomatitis  1  76/111 (68.47%) 
nausea  1  45/111 (40.54%) 
constipation  1  38/111 (34.23%) 
vomiting  1  28/111 (25.23%) 
diarrhea  1  25/111 (22.52%) 
abdominal pain  1  12/111 (10.81%) 
abdominal pain upper  1  9/111 (8.11%) 
gastroesophageal reflux disease  1  7/111 (6.31%) 
flatulence  1  6/111 (5.41%) 
hemorrhoids  1  6/111 (5.41%) 
oral pain  1  6/111 (5.41%) 
General disorders   
fatigue  1  38/111 (34.23%) 
pyrexia  1  32/111 (28.83%) 
edema peripheral  1  31/111 (27.93%) 
asthenia  1  12/111 (10.81%) 
mucosal inflammation  1  10/111 (9.01%) 
pain  1  6/111 (5.41%) 
Infections and infestations   
sinusitis  1  11/111 (9.91%) 
upper respiratory tract infection  1  11/111 (9.91%) 
nasopharyngitis  1  9/111 (8.11%) 
folliculitis  1  6/111 (5.41%) 
oral herpes  1  6/111 (5.41%) 
Investigations   
platelet count decreased  1  13/111 (11.71%) 
alanine aminotransferase increased  1  10/111 (9.01%) 
hemoglobin decreased  1  9/111 (8.11%) 
weight decreased  1  8/111 (7.21%) 
white blood cell count decreased  1  7/111 (6.31%) 
neutrophil count decreased  1  6/111 (5.41%) 
Metabolism and nutrition disorders   
hypokalemia  1  17/111 (15.32%) 
hypomagnesemia  1  10/111 (9.01%) 
anorexia  1  9/111 (8.11%) 
decreased appetite  1  9/111 (8.11%) 
dehydration  1  6/111 (5.41%) 
Musculoskeletal and connective tissue disorders   
back pain  1  14/111 (12.61%) 
pain in extremity  1  13/111 (11.71%) 
musculoskeletal pain  1  10/111 (9.01%) 
arthralgia  1  8/111 (7.21%) 
muscle spasms  1  8/111 (7.21%) 
myalgia  1  7/111 (6.31%) 
Nervous system disorders   
headache  1  13/111 (11.71%) 
dizziness  1  10/111 (9.01%) 
paresthesia  1  6/111 (5.41%) 
Psychiatric disorders   
anxiety  1  8/111 (7.21%) 
insomnia  1  6/111 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
cough  1  32/111 (28.83%) 
epistaxis  1  29/111 (26.13%) 
dyspnea  1  18/111 (16.22%) 
pharyngolaryngeal pain  1  15/111 (13.51%) 
Skin and subcutaneous tissue disorders   
rash  1  17/111 (15.32%) 
pruritis  1  16/111 (14.41%) 
night sweats  1  12/111 (10.81%) 
skin lesion  1  8/111 (7.21%) 
skin ulcer  1  8/111 (7.21%) 
blister  1  6/111 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Outcome Measure (primary and secondary), Serious Adverse Event and Adverse Event data presented have a cut-off date of August 2009.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Allos agreements with investigators (PIs) may vary. The PI may publish/make public data from the trial after the earlier of publication by Allos or 18 months after study completion. Allos can review results communications prior to public release and can embargo communications regarding trial results for a period less than or equal to 90 days from submission for review. Allos can request changes to the communication related to confidential or patent information, or to ensure accuracy.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Saunders, M.D.
Organization: Allos Therapeutics, Inc
Phone: 303-426-6262
EMail: msaunders@allos.com
Layout table for additonal information
Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00364923     History of Changes
Other Study ID Numbers: PDX-008
2006-002811-29 ( EudraCT Number )
First Submitted: August 14, 2006
First Posted: August 16, 2006
Results First Submitted: October 23, 2009
Results First Posted: February 1, 2010
Last Update Posted: May 10, 2013