Peripheral T Cell LymphomaPhase 3LTPNCT00970385
Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
A Phase 3 study testing CHOP21, VIP/ABVD and Radiotherapy consolidation in people with Peripheral T Cell Lymphoma, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- CHOP21, VIP/ABVD and Radiotherapy consolidation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1995to Sep 2008
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed untreated PTCL
- age 18 and 70 years
- performance status ≤ 2
- Ann Arbor stage I to IV
- normal cardiac ventricular ejection fraction over 50%
- normal hepatic function (asat, ALAT, PAL < 2.5 ULN)
Who cannot join
- cutaneous form of PTCL
- previous treatment
- age < 18 and > 70
- performance status > 2
- abnormal cardiac or hepatic functions
- HIV-, HCV- or HBV- positivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP
This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.
Read the detailed description
Induction therapy:
ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days
Consolidation therapy:
For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- CHOP21, VIP/ABVD, Radiotherapy consolidation
- 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.
CHOP21Drug
Also called CHOP 21 arm
CHOP regimen:
- cyclophosphamide 750 mg/m2 intravenously (IV) day 1
- doxorubicin 50 mg/m2 IV day 1
- vincristine 1,4 mg/m2 (maximum 2 mg) day 1
- prednisone 100 mg/m2/D from D1 to D5.
VIP/ABVDDrug
Also called VIP/ABVD Arm
VIP regimen:
- etoposide 100 mg/m2/D IV from D1 to D3
- ifosfamide 1000 mg/m2/D from D1 to D5
- cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5
ABVD regimen:
- doxorubicin50 mg/m2/D on D1 and D14
- bleomycin 10 mg/m2/D
- vinblastine 10 mg/m2/D
- dacarbazine 375 mg/m2/D
Radiotherapy consolidationRadiation
Also called Consolidation treatment
The treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field.
| Study group | Role | What they receive |
|---|---|---|
| CHOP 21 | Active comparator | Induction therapy CHOP every 21 days:
* cyclophosphamide 750 mg/m2 intravenously (IV) day 1
* doxorubicin 50 mg/m2 IV day 1
* vincristine 1,4 mg/m2 (maximum 2 mg) day 1
* prednisone 100 mg/m2/D from D1 to D5. Receives: Drug: CHOP21; Radiation: Radiotherapy consolidation |
| VIP/ABVD arm | Experimental | VIP cycle:
* etoposide 100 mg/m2/D IV from D1 to D3
* ifosfamide 1000 mg/m2/D from D1 to D5
* cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5
ABVD cycle:
* doxorubicin50 mg/m2/D on D1 and D14
* bleomycin 10 mg/m2/D
* vinblastine 10 mg/m2/D
* dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD). Receives: Drug: VIP/ABVD; Radiation: Radiotherapy consolidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
Measured: 2 years
Secondary outcomes (4)
Overall survival (OS)
Measured: 6 years
response rate at the end of the treatment
Measured: 6-8 months
progression free survival (PFS)
Measured: 6 years
hematotoxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJan 1995
- Primary completionDec 2002
- Study completionSep 2008
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 Hospital, GrenobleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Investigators
- Remy GRESSIN, MD MS, Principal investigator, CHU Grenoble GOELAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970385
- Sponsor's protocol ID
- LTP 95
- Acronym
- LTP
- Status last verified
- Sep 2009
- First submitted
- 20 Aug 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP
- ClinicalTrials.gov ID
- NCT00970385
- Acronym / sponsor ID
- LTP / LTP 95
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Study start
- Jan 1995
- Primary completion
- Dec 2002 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Sep 2009 (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 multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.
Detailed description
Induction therapy:
ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days
Consolidation therapy:
For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHOP 21 | Active comparator | Drug: CHOP21, Radiation: Radiotherapy consolidationInduction therapy CHOP every 21 days: * cyclophosphamide 750 mg/m2 intravenously (IV) day 1 * doxorubicin 50 mg/m2 IV day 1 * vincristine 1,4 mg/m2 (maximum 2 mg) day 1 * prednisone 100 mg/m2/D from D1 to D5. |
| VIP/ABVD arm | Experimental | Drug: VIP/ABVD, Radiation: Radiotherapy consolidationVIP cycle: * etoposide 100 mg/m2/D IV from D1 to D3 * ifosfamide 1000 mg/m2/D from D1 to D5 * cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5 ABVD cycle: * doxorubicin50 mg/m2/D on D1 and D14 * bleomycin 10 mg/m2/D * vinblastine 10 mg/m2/D * dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- newly diagnosed untreated PTCL
- age 18 and 70 years
- performance status ≤ 2
- Ann Arbor stage I to IV
- normal cardiac ventricular ejection fraction over 50%
Key exclusion criteria (6 listed)
- cutaneous form of PTCL
- previous treatment
- age < 18 and > 70
- performance status > 2
- abnormal cardiac or hepatic functions
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 |
|---|---|---|
| CHOP21Also: CHOP 21 armCHOP regimen: * cyclophosphamide 750 mg/m2 intravenously (IV) day 1 * doxorubicin 50 mg/m2 IV day 1 * vincristine 1,4 mg/m2 (maximum 2 mg) day 1 * prednisone 100 mg/m2/D from D1 to D5. | Drug | CHOP 21 |
| VIP/ABVDAlso: VIP/ABVD ArmVIP regimen: * etoposide 100 mg/m2/D IV from D1 to D3 * ifosfamide 1000 mg/m2/D from D1 to D5 * cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5 ABVD regimen: * doxorubicin50 mg/m2/D on D1 and D14 * bleomycin 10 mg/m2/D * vinblastine 10 mg/m2/D * dacarbazine 375 mg/m2/D | Drug | VIP/ABVD arm |
| Radiotherapy consolidationAlso: Consolidation treatmentThe treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field. | Radiation | CHOP 21, VIP/ABVD arm |
Primary outcome
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
Time frame: 2 years
4 secondary outcomes
Overall survival (OS)
Time frame: 6 years
response rate at the end of the treatment
Time frame: 6-8 months
progression free survival (PFS)
Time frame: 6 years
hematotoxicity
Time frame: 6 months
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 9 Sep 2009.
Related trials for Peripheral T Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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.
Remy GRESSIN, MD MS principal investigator
CHU Grenoble GOELAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHOP21, VIP/ABVD and Radiotherapy consolidation in people with Peripheral T Cell Lymphoma, run by University Hospital, Grenoble at 1 site in France.
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 6 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 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
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?
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL. (time frame: 2 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 9 Sep 2009.