Peripheral T-Cell LymphomaPhase 2NCT00791947
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
A Phase 2 study testing CHOEP + G-CSF followed by BEAM in people with Peripheral T-Cell Lymphoma, run by University of Aarhus at 9 sites in 3 countries.
Trial summary
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma. The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- CHOEP + G-CSF followed by BEAM
- Type of treatment
- Injection or infusion
- How many people
- 166 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Oct 2001to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (<10cm) can be treated individually at the discretion of the responsible physician.
- Following histologic subtypes (WHO classification) are eligible for inclusion in the study:
- Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
- NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
- Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
- formed consent based on oral and written patient information (Appendix I)
Who cannot join
- Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
- Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
- WHO Performance Status grade 4 (Appendix II)
- Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
- Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
- Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
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- Patients with seropositivity for the human immunodeficiency virus.
- Patients with other active and therapeutically uncontrolled infection.
- Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Norway4 sites
Oslo University Hospital
Oslo, 0310
Ullevaal University Hospital
Oslo, 0407
Rogaland Hospital
Rogaland
St.Olavs Hospital
Trondheim, 7006
Denmark3 sites
Aarhus University Hospital
Aarhus, 8000
Copenhagen Hospital
Copenhagen
Vejle Hospital
Vejle
Finland2 sites
Kuopio University Hospital
Kuopio, 70211
OULO University Hospital
Oulu, Oulo
About this study
Official title: A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.
The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- CHOEP + G-CSF followed by BEAM
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOEP + G-CSF followed by BEAMDrug
CHOEP:
Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5
BEAM:
Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startOct 2001
- Primary completionAug 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Lymphoma Group
- Responsible party
- Sponsor
- Investigators
- Francesco d'Amore, MD, Principal investigator, Nordic Lymphoma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791947
- Sponsor's protocol ID
- NLG-T-01
- Other IDs
- 2006-000389-35
- Status last verified
- Sep 2011
- First submitted
- 14 Nov 2008
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
- ClinicalTrials.gov ID
- NCT00791947
- Acronym / sponsor ID
- NLG-T-01
- Conditions
- Peripheral T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Nordic Lymphoma Group
- Study start
- Oct 2001
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.
The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (<10cm) can be treated individually at the discretion of the responsible physician.
- Following histologic subtypes (WHO classification) are eligible for inclusion in the study:
- Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
- NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
- Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
Key exclusion criteria (9 listed)
- Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
- Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
- WHO Performance Status grade 4 (Appendix II)
- Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
- Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
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 |
|---|---|---|
| CHOEP + G-CSF followed by BEAMCHOEP: Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5 BEAM: Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6 | Drug | – |
Primary outcome
Time to treatment failure
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
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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.
Francesco d'Amore, MD principal investigator
Nordic Lymphoma Group
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHOEP + G-CSF followed by BEAM in people with Peripheral T-Cell Lymphoma, run by University of Aarhus at 9 sites in 3 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 6 inclusion and 9 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway, Denmark, Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to treatment failure (time frame: 5 years). 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 8 Sep 2011.