T-cell LymphomaPhase 2BENTLYNCT00959686
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
A Phase 2 study testing Bendamustine in people with T-cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphoma
- What is being tested?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 18 years.
- Refractory or relapsed peripheral T-cell NHL (PTCL)
- Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy
- ECOG score less than 2
- No major organ dysfunction unrelated to lymphoma.
Who cannot join
- Pregnant or breast feeding women
- ECOG score > 2
- Estimate survival time < 3 months
- Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy
- Creatinine clearance < 10 ml/min or severe hepatic dysfunction not related to lymphoma.
- Previous chemotherapy/immunotherapy within 3 weeks before study entry
Show all 10Show fewer
- Known seropositive for or active viral infection HIV, EBV, HCV
- CNS lymphoma
- T-cell Leukemia lymphoma associated with HTLV1
- Sezary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".
Read the detailed description
The primary objective of this study is to define the activity of Bendamustine for the treatment of T cells lymphomas. The activity of Bendamustine is determined by the response rate (RR) to the treatment within 22 days after intravenous infusion which enables to get a confidence interval of 95 % for the probability of an overall response rate (ORR).
- Conditions
- T-cell Lymphoma
- Being tested
- Bendamustine
- Keywords
- Bendamustine refractory or relapsed T-cell lymphoma.
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustin®
Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the overall response rate (ORR) (CR+CRu+PR)
Measured: 36 months follow-up
Secondary outcomes (2)
Evaluation of the tolerance and Safety of bendamustine in this subset of patients
Measured: 36 months follow-up
Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.
Measured: 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Gandhi DAMAJ, MD MS, Principal investigator, French Innovative Leukemia OrganisationRémy GRESSIN, MD MS, Principal investigator, French Innovative Leukemia OrganisationTHierry LAMY, PD MS, Principal investigator, French Innovative Leukemia OrganisationOlivier TOURNILHAC, PD MS, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959686
- Sponsor's protocol ID
- "BENTLY"
- Acronym
- BENTLY
- Status last verified
- Jun 2011
- First submitted
- 14 Aug 2009
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Bene MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29.
PubMed 23109692
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
- ClinicalTrials.gov ID
- NCT00959686
- Acronym / sponsor ID
- BENTLY / "BENTLY"
- Conditions
- T-cell Lymphoma
- Keywords
- Bendamustine refractory or relapsed T-cell lymphoma.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Aug 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.
A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".
Detailed description
The primary objective of this study is to define the activity of Bendamustine for the treatment of T cells lymphomas. The activity of Bendamustine is determined by the response rate (RR) to the treatment within 22 days after intravenous infusion which enables to get a confidence interval of 95 % for the probability of an overall response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: BendamustineBendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged more than 18 years.
- Refractory or relapsed peripheral T-cell NHL (PTCL)
- Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy
- ECOG score less than 2
- No major organ dysfunction unrelated to lymphoma.
Key exclusion criteria (10 listed)
- Pregnant or breast feeding women
- ECOG score > 2
- Estimate survival time < 3 months
- Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy
- Creatinine clearance < 10 ml/min or severe hepatic dysfunction not related to lymphoma.
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 |
|---|---|---|
| BendamustineAlso: Ribomustin®Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles | Drug | Bendamustine |
Primary outcome
Determine the overall response rate (ORR) (CR+CRu+PR)
Time frame: 36 months follow-up
2 secondary outcomes
Evaluation of the tolerance and Safety of bendamustine in this subset of patients
Time frame: 36 months follow-up
Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.
Time frame: 36 months follow-up
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 12 Feb 2013.
- Derived from this study: PubMed 23109692Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Bene MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29.
Related trials for T-cell Lymphoma
RecruitingObservational study
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
Lymphoma, Leukemia
Active, not recruitingPhase 1
A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
Lymphoma, Non-Hodgkin
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
RecruitingObservational study
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Mycosis Fungoides, Sezary Syndrome
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
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.
Gandhi DAMAJ, MD MS principal investigator
French Innovative Leukemia Organisation
Rémy GRESSIN, MD MS principal investigator
French Innovative Leukemia Organisation
THierry LAMY, PD MS principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine in people with T-cell Lymphoma, run by French Innovative Leukemia Organisation 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 5 inclusion and 10 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 12 Feb 2013. 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 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?
Determine the overall response rate (ORR) (CR+CRu+PR) (time frame: 36 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959686, which also lists 1 linked publication.
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 12 Feb 2013.