Peripheral T-cell LymphomaPhase 3NCT01420679
Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
A Phase 3 study testing Pralatrexate Injection in people with Peripheral T-cell Lymphoma, run by Spectrum Pharmaceuticals, Inc at 55 sites in 13 countries.
Trial summary
The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 55 sitesin 13 countries
- Study dates
- Aug 2011to Dec 2017
- Phase
- Phase 3
- 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
- Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:
- T/natural killer (NK)-cell leukemia/lymphoma
- Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
- Angioimmunoblastic TCL
- Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
- PTCL-unspecified
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- Enteropathy-type intestinal lymphoma
- Hepatosplenic TCL
- Subcutaneous panniculitis TCL
- Transformed mycosis fungoides (tMF)
- Extranodal T/NK-cell lymphoma nasal or nasal type
- Primary cutaneous gamma-delta TCL
- Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL
- Documented completion of at least 6 cycles of CHOP-based therapy:
- CHOP 21
- CHOP 14
- CHOP + etoposide
- Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
- Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
- Eastern Cooperative Oncology Group performance status less than or equal to 2.
- Adequate blood, liver, and kidney function as defined by laboratory tests.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
- Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
- Has given written informed consent.
Who cannot join
- Patient has:
- Precursor T/NK neoplasms
- ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy
- T cell prolymphocytic leukemia
- T cell large granular lymphocytic leukemia
- Mycosis fungoides, except tMF
Show all 27Show fewer
- Sézary syndrome
- Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
- If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.
- non-melanoma skin cancer
- carcinoma in situ of the cervix
- localized prostate cancer
- localized thyroid cancer
- Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:
- Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
- Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
- Prior exposure to pralatrexate.
- Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
- Planned use of any treatment for PTCL during the course of the study.
- Patient has:
- Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
- Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
- Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
- Symptomatic central nervous system metastases or lesions requiring treatment.
- Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
- Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
- Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure.
Trial locations and contacts
55 sites in 13 countries.
55 sites in 13 countries
United Kingdom11 sites
Antrim Area Hospital
Antrim, Northern Ireland, BT41 2RL
Belfast City Hospital
Belfast, BT9 7AB
Velindre Hospital
Cardiff, CF14 2TL
NHS Greater Glasgow and Clyde Western Infirmary
Glasgow, Scotland, G11 6NT
Royal Liverpool University Hospital
Liverpool, L7 8XP
Mount Vernon Cancer Centre
Middlesex, HA6 2RN
Derriford Hospital
Plymouth, England, PL68DH
Poole Hospital NHS Foundation Trust, Poole General Hospital
Poole, Dorset, BH15 2JB
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
UHCW (University Hospital Coventry and Warwickshire)
Warwick, CA34 5BW
Sandwell & West Birmingham Hospitals NHS Trust
West Bromwich, England, B71 4HJ
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Center
Bedford Park, South Australia, 5042
Monash Medical Centre
Clayton, Victoria, 3168
Saint Vincent's Hospital Melbourne
Fitzroy, Victoria, 3109
Frankston Hospital
Frankston, Victoria, 3199
Royal Hobart Hospital
Hobart, Tasmania, 7001
Cabrini Health
Malvern, Victoria, 3144
Royal Perth Hospital
Perth, Western Australia, 6000
Spain8 sites
Complejo Hospitalario Universitario A Coruña- Hospital A Coruña
A Coruña, 15006
Hospital General Vall d'Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital de Madrid Norte-Sanchinarro
Madrid, 28050
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28222
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra, Servicio de Hematologia
Pamplona, Navarre, 31008
Italy6 sites
Az. Ospedaliera Universitaria S. Orsola Malpighi
Bologna, 40138
Spedali Civili di Brescia
Brescia, 25123
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli, 47014
Ospedale S. Maria delle Croci
Ravenna, 48121
Università Cattolica del Sacro Cuore
Roma, 00168
Az. Ospedaliera Università Senese
Siena, 53100
Israel4 sites
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah Ein-Kerem Medical Centre
Jerusalem, 91120
Rabin Medical Center
Petah Tikva, 49100
Chaim Sheba Medical Center
Tel HaShomer, 52621
New Zealand4 sites
Auckland City Hospital / Auckland University
Auckland, 1010
Christchurch Hospital
Christchurch, 8011
North Shore Hospital
Milford
Middlemore Hospital
Otahuhu, Auckland, 1640
United States3 sites
New York Presbyterian Hospital
New York, New York, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Detroit Clinical Research Center, PC
Novi, Michigan, 48377
Poland3 sites
Dept of Hematology and Transplantology
Gdansk, 80-952
Małopolskie Centrum Medyczne
Krakow, 30-510
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, 02-781
Belgium2 sites
AZ Sint-Jan
Bruges, 8000
Universitair Ziekenhuis Gent
Ghent, 9000
Canada2 sites
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy
The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.
Read the detailed description
This was an international, multi-center, randomized, Phase 3, open-label study of sequential pralatrexate versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with CHOP-based chemotherapy.
Upon documentation of completion of an objective response following at least 6 cycles of a designated CHOP-based chemotherapy confirmation of histopathology by independent review, and confirmation that all eligibility criteria were met, patients were randomized in a 2:1 ratio to either pralatrexate or observation, according to a permuted block design with stratification factor of Tumor Response per Investigator at completion of CHOP-based therapy (Complete Response [CR] vs Partial Response [PR]).
All patients who receive at least 1 dose of pralatrexate were followed for safety through 35 (± 5) days after their last dose of pralatrexate or until all treatment-related AEs have resolved or returned to baseline/Grade 1, whichever is longer, or until it was determined that the outcome does not change with further follow-up.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Pralatrexate Injection
- Keywords
- Lymphoproliferative Disorders, Lymphoma, Non-Hodgkin's Lymphoma, T-cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoproliferative Disorders, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pralatrexate InjectionDrug
Also called FOLOTYN, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin
Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride).
Initial dose: 30 mg/m2
Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met.
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate | Experimental | Patients randomized to the Pralatrexate Arm will receive pralatrexate injection and Vitamins B12 and Folic Acid until a criterion for pralatrexate injection treatment discontinuation is met. Receives: Drug: Pralatrexate Injection |
| Observation | No intervention | Patients randomized to the Observation Arm will receive Vitamins B12 and Folic Acid and remain under observation until a criterion for observation discontinuation is met. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization.
Measured: From randomization to the date of progression of disease or death due to any cause (up to 76 months)
Overall Survival (OS)
Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
Measured: From randomization until death (up to 76 months)
Secondary outcomes (2)
Objective Response Rate
Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites.
Measured: Up to 2 years
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.
Measured: From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2017
- Study completionDec 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420679
- Sponsor's protocol ID
- PDX-017
- Other IDs
- 2010-022230-81
- Status last verified
- Nov 2021
- First submitted
- 18 Aug 2011
- Last updated
- 19 Nov 2021
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01420679
- Acronym / sponsor ID
- PDX-017
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Lymphoproliferative Disorders, Lymphoma, Non-Hodgkin's Lymphoma, T-cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.
Detailed description
This was an international, multi-center, randomized, Phase 3, open-label study of sequential pralatrexate versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with CHOP-based chemotherapy.
Upon documentation of completion of an objective response following at least 6 cycles of a designated CHOP-based chemotherapy confirmation of histopathology by independent review, and confirmation that all eligibility criteria were met, patients were randomized in a 2:1 ratio to either pralatrexate or observation, according to a permuted block design with stratification factor of Tumor Response per Investigator at completion of CHOP-based therapy (Complete Response [CR] vs Partial Response [PR]).
All patients who receive at least 1 dose of pralatrexate were followed for safety through 35 (± 5) days after their last dose of pralatrexate or until all treatment-related AEs have resolved or returned to baseline/Grade 1, whichever is longer, or until it was determined that the outcome does not change with further follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate | Experimental | Drug: Pralatrexate InjectionPatients randomized to the Pralatrexate Arm will receive pralatrexate injection and Vitamins B12 and Folic Acid until a criterion for pralatrexate injection treatment discontinuation is met. |
| Observation | No intervention | –Patients randomized to the Observation Arm will receive Vitamins B12 and Folic Acid and remain under observation until a criterion for observation discontinuation is met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:
- Documented completion of at least 6 cycles of CHOP-based therapy:
- Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
- Eastern Cooperative Oncology Group performance status less than or equal to 2.
- Adequate blood, liver, and kidney function as defined by laboratory tests.
Key exclusion criteria (27 listed)
- Patient has:
- If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.
- Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:
- Prior exposure to pralatrexate.
- Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
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, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterinIntravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride). Initial dose: 30 mg/m2 Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met. | Drug | Pralatrexate |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From randomization to the date of progression of disease or death due to any cause (up to 76 months)
PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization.
Overall Survival (OS)
Time frame: From randomization until death (up to 76 months)
Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
2 secondary outcomes
Objective Response Rate
Time frame: Up to 2 years
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities
Time frame: From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pralatrexate Injection in people with Peripheral T-cell Lymphoma, run by Spectrum Pharmaceuticals, Inc at 55 sites in 13 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 24 inclusion and 27 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: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United Kingdom, Australia, Spain, Italy, Israel and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Nov 2021). 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?
Progression-Free Survival (PFS) (time frame: From randomization to the date of progression of disease or death due to any cause (up to 76 months)). The study lists 2 primary outcomes in all. 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 Nov 2021.