Mantle Cell Lymphoma RefractoryPhase 1/2T³NCT01389427
Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL).
A Phase 1/2 study testing Torisel dose 15 mg and R-CHOP, Torisel dose 15 mg and R-FC and Torisel dose 15 mg and R-DHA in people with Mantle Cell Lymphoma Refractory, run by The Lymphoma Academic Research Organisation at 11 sites in France.
Trial summary
This is a multicenter, open label, three arms, Phase IB study. A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma Refractory
- What is being tested?
- Torisel dose 15 mg and R-CHOP, Torisel dose 15 mg and R-FC and Torisel dose 15 mg and R-DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 11 sitesFrance
- Study dates
- Nov 2011to Sep 2015
- Phase
- Phase 1/2
- 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 with histologically or cytologically confirmed refractory or relapsed Mantle Cell Lymphoma (at initial diagnosis or relapse),
- Ann Arbor Stage I-IV with at least one tumor site measurable,
- Patients who received prior therapy (at least one but no more than three lines therapies) for Mantle Cell Lymphoma (MCL),
- Aged ≥ 18 years,
- ECOG performance status 0, 1 or 2,
- Adequate hepatic and renal function :
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- Serum Glutamic Oxaloacetic Transaminase (SGOT)/AST or Serum Glutamic Pyruvic TransaminaseSGPT/ALT ≤ 3.0 x upper limit of normal (ULN),
- Serum Total Bilirubin ≤ 1.5 mg/dL (26 μmol/L) except in case of hemolytic anemia,
- Serum Creatinine ≤ 2 mg/dL (177 μmol/L) or calculated Creatinine Clearance (Cock-croft-Gault formula) of ≥ 50 mL /min
- Adequate bone marrow reserve :
- Absolute neutrophil count (ANC) ≥ 1 G/L (1,000 cells/mm³)
- Platelets count ≥ 50 G/L
- Hemoglobin ≥ 9.0 g/dL,
- Signed and date informed consent,
- Life expectancy of ≥ 90 days (3 months)
Who cannot join
- Other types of lymphomas, e.g. B-cell lymphoma,
- Contraindication to any drug contained in the three chemotherapy regimens (R-CHOP, R-FC, R-DHA),
- Tested positive for HIV,
- Active Hepatitis B and/or C,
- Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited, to active systemic fungal infection, diagnosis of fever and neutropenia,
- Any serious active disease or co-morbid medical condition (according to investigator's decision),
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- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
- Received a biological agent for anti-neoplastic intent within 30 days prior to the first dose of study drug,
- Use of any standard or experimental anti-cancer drug therapy within 30 days prior to the first dose of study drug,
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years,
- Left Ventricular Ejection Fraction < 45% (calculated by echocardiographic or scintigraphic method),
- Pregnancy or breast feeding women,
- Women of childbearing potential who not willing to use an adequate method of birth controls for the duration of the study and for twelve months after the end of treatment,
- Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for twelve months after the end of treatment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital Henri Mondor
Créteil, 94010
CHU de Dijon
Dijon, 21000
CHU de Grenoble MICHALLON
Grenoble, Hôpital Nord 217, 38043
Hôpital Saint-Eloi
Montpellier, 34295
Hôtel Dieu - Université de Nantes
Nantes, Place Alexis Ricordeau, 44093
Hôpital Saint Louis
Paris, 75475
Hôpital Necker
Paris, 75743
Groupe hospitalier Sud Hôpital Haut-Lévêque
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU Pontchaillou
Rennes, 35003
CHU de Tours - Hôpital Bretonneau
Tours, 37000
About this study
Official title: A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Rituximab-Aracytine High Dose-Dexamethasone (T-R-DHA) for the Treatment of Patients in Relapsed/Refractory Mantle Cell Lymphoma
This is a multicenter, open label, three arms, Phase IB study.
A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL):
- Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks for 6 cycles,
- Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,
- Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6 cycles.
Read the detailed description
This is a three arms trial that investigates Temsirolimus (Torisel™) in combination with three chemotherapy regimens (R-CHOP, R-FC or R-DHA).
Primary Objective:
- To assess the feasibility of these three chemotherapy regimens in combination with Temsirolimus (Torisel™) and to assess the incidence of dose limiting toxicities (DLT) during the two first cycles of Temsirolimus (Torisel™) in combination with three chemotherapy regimens in order to determine the maximal tolerate dose (MTD) in a dose escalating study design in a population of patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Secondary objectives:
- To assess the safety of the association Temsirolimus with the three chemotherapy regimens,
- To determine the efficacy of the association of Temsirolimus (Torisel™) and these three chemotherapy regimens after 4 cycles and after 6 cycles at the end of treatment: response rate and complete response rate (CR), progression-free survival (PFS), response duration (RD) and overall survival (OS).
All subjects who received at least one dose of Temsirolimus (Torisel™) will be considered evaluable and will be included in the safety analysis.
- Conditions
- Mantle Cell Lymphoma Refractory
- Being tested
- Torisel dose 15 mg and R-CHOP, Torisel dose 15 mg and R-FC, Torisel dose 15 mg and R-DHA, Torisel dose 25 mg and R-CHOP, Torisel dose 50 mg and R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torisel dose 15 mg and R-CHOPDrug
Also called Arm A cohort -1
Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 15 mg and R-FCDrug
Also called Arm B cohort -1
Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 15 mg and R-DHADrug
Also called Arm C cohort -1
Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 25 mg and R-CHOPDrug
Also called Arm A cohort 1
Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 50 mg and R-CHOPDrug
Also called Arm A cohort 2
Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 75 mg and R-CHOPDrug
Also called Arm A cohort 3
Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 25 mg and R-FCDrug
Also called Arm B cohort 1
Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 50 mg and R-FCDrug
Also called Arm B cohort 2
Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 75 mg and R-FCDrug
Also called Arm B cohort 3
Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 25 mg and R-DHADrug
Also called Arm C cohort 1
Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel dose 50 mg and R-DHADrug
Also called Arm C cohort 2
Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Torisel 75 mg and R-DHADrug
Also called Arm C cohort 3
Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
| Study group | Role | What they receive |
|---|---|---|
| Torisel 15 mg | Experimental | Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 15 mg Receives: Drug: Torisel dose 15 mg and R-CHOP; Drug: Torisel dose 15 mg and R-FC; Drug: Torisel dose 15 mg and R-DHA |
| Torisel 25 mg | Experimental | Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 25 mg Receives: Drug: Torisel dose 25 mg and R-CHOP; Drug: Torisel dose 25 mg and R-FC; Drug: Torisel dose 25 mg and R-DHA |
| Torisel 50 mg | Experimental | Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 50 mg Receives: Drug: Torisel dose 50 mg and R-CHOP; Drug: Torisel dose 50 mg and R-FC; Drug: Torisel dose 50 mg and R-DHA |
| Torisel 75 mg | Experimental | Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 75 mg Receives: Drug: Torisel dose 75 mg and R-CHOP; Drug: Torisel dose 75 mg and R-FC; Drug: Torisel 75 mg and R-DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT)
The evaluable for DLT population is the subset of patients from all treated population with a DLT assessment at the two first cycles.
Measured: 56 days
Secondary outcomes (6)
Complete Response Rate(CR) after 4 cycles and at the end of treatment
Response at the end of treatment will be assessed after four cycles and at the end of complete treatment if the patient received all planned cycles or at withdrawal. Patients without response assessments (due to whatever reason) will be considered non-responders. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during the treatment phase even if they were prematurely withdrawn as responders.
Measured: 28 days up to 42 days after the last treatment dose
Progression-free survival (PFS)
Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause, according to the Cheson 2007 criteria. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.
Measured: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years
Duration of Response
Duration of response will be measured from the date of first documentation of a response (CR or PR at the end of treatment) to the date of first documented evidence of progression/relapse or death from any cause, according to the Cheson 2007 criteria. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.
Measured: From the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause up to 3 years
Overall Response at the end of treatment
The same disease response assessment used for complete response rate will be considered to determine the Overall Response Rate. A Patient will be defined as a responder if he/she has a complete response (CR/CRu) or partial response (PR) after four cycles and at the end of treatment. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during treatment phase even if they were prematurely withdrawn as responders.
Measured: 28 days up to 42 days after the last treatment dose
Overall Survival (OS)
Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients who are alive at the time of analysis will be censored at the date of the last contact.
Measured: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years
Safety of association Temsirolimus with the three chemotherapy regimens
All subjects who received at least one dose of Temsirolimus (Torisel™) will be considered evaluable and will be included in the safety analysis.
Analysis of safety will be performed by summarizing adverse events, laboratory data, vital signs and ECOG per-formance status. When applicable, a summary of safety data will also be performed by cycle.
Measured: From the date of informed consent signature to 28 days after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell Lymphoma RefractoryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Responsible party
- Sponsor
- Investigators
- Steven LE GOUILL, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389427
- Sponsor's protocol ID
- T³
- Acronym
- T³
- Status last verified
- Mar 2017
- First submitted
- 4 Jul 2011
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Rituximab-Aracytine High Dose-Dexamethasone (T-R-DHA) for the Treatment of Patients in Relapsed/Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01389427
- Acronym / sponsor ID
- T³ / T³
- Conditions
- Mantle Cell Lymphoma Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Study start
- Nov 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jul 2011 (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, open label, three arms, Phase IB study.
A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL):
- Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks for 6 cycles,
- Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,
- Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6 cycles.
Detailed description
This is a three arms trial that investigates Temsirolimus (Torisel™) in combination with three chemotherapy regimens (R-CHOP, R-FC or R-DHA).
Primary Objective:
- To assess the feasibility of these three chemotherapy regimens in combination with Temsirolimus (Torisel™) and to assess the incidence of dose limiting toxicities (DLT) during the two first cycles of Temsirolimus (Torisel™) in combination with three chemotherapy regimens in order to determine the maximal tolerate dose (MTD) in a dose escalating study design in a population of patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
Secondary objectives:
- To assess the safety of the association Temsirolimus with the three chemotherapy regimens,
- To determine the efficacy of the association of Temsirolimus (Torisel™) and these three chemotherapy regimens after 4 cycles and after 6 cycles at the end of treatment: response rate and complete response rate (CR), progression-free survival (PFS), response duration (RD) and overall survival (OS).
All subjects who received at least one dose of Temsirolimus (Torisel™) will be considered evaluable and will be included in the safety analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Torisel 15 mg | Experimental | Drug: Torisel dose 15 mg and R-CHOP, Drug: Torisel dose 15 mg and R-FC, Drug: Torisel dose 15 mg and R-DHAChemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 15 mg |
| Torisel 25 mg | Experimental | Drug: Torisel dose 25 mg and R-CHOP, Drug: Torisel dose 25 mg and R-FC, Drug: Torisel dose 25 mg and R-DHAChemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 25 mg |
| Torisel 50 mg | Experimental | Drug: Torisel dose 50 mg and R-CHOP, Drug: Torisel dose 50 mg and R-FC, Drug: Torisel dose 50 mg and R-DHAChemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 50 mg |
| Torisel 75 mg | Experimental | Drug: Torisel dose 75 mg and R-CHOP, Drug: Torisel dose 75 mg and R-FC, Drug: Torisel 75 mg and R-DHAChemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 75 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically or cytologically confirmed refractory or relapsed Mantle Cell Lymphoma (at initial diagnosis or relapse),
- Ann Arbor Stage I-IV with at least one tumor site measurable,
- Patients who received prior therapy (at least one but no more than three lines therapies) for Mantle Cell Lymphoma (MCL),
- Aged ≥ 18 years,
- ECOG performance status 0, 1 or 2,
Key exclusion criteria (14 listed)
- Other types of lymphomas, e.g. B-cell lymphoma,
- Contraindication to any drug contained in the three chemotherapy regimens (R-CHOP, R-FC, R-DHA),
- Tested positive for HIV,
- Active Hepatitis B and/or C,
- Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited, to active systemic fungal infection, diagnosis of fever and neutropenia,
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 |
|---|---|---|
| Torisel dose 15 mg and R-CHOPAlso: Arm A cohort -1Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 15 mg |
| Torisel dose 15 mg and R-FCAlso: Arm B cohort -1Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 15 mg |
| Torisel dose 15 mg and R-DHAAlso: Arm C cohort -1Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 15 mg |
| Torisel dose 25 mg and R-CHOPAlso: Arm A cohort 1Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 25 mg |
| Torisel dose 50 mg and R-CHOPAlso: Arm A cohort 2Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 50 mg |
| Torisel dose 75 mg and R-CHOPAlso: Arm A cohort 3Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 75 mg |
| Torisel dose 25 mg and R-FCAlso: Arm B cohort 1Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 25 mg |
| Torisel dose 50 mg and R-FCAlso: Arm B cohort 2Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 50 mg |
| Torisel dose 75 mg and R-FCAlso: Arm B cohort 3Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 75 mg |
| Torisel dose 25 mg and R-DHAAlso: Arm C cohort 1Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 25 mg |
| Torisel dose 50 mg and R-DHAAlso: Arm C cohort 2Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 50 mg |
| Torisel 75 mg and R-DHAAlso: Arm C cohort 3Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL). | Drug | Torisel 75 mg |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 56 days
The evaluable for DLT population is the subset of patients from all treated population with a DLT assessment at the two first cycles.
6 secondary outcomes
Complete Response Rate(CR) after 4 cycles and at the end of treatment
Time frame: 28 days up to 42 days after the last treatment dose
Progression-free survival (PFS)
Time frame: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years
Duration of Response
Time frame: From the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause up to 3 years
Overall Response at the end of treatment
Time frame: 28 days up to 42 days after the last treatment dose
Overall Survival (OS)
Time frame: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years
Safety of association Temsirolimus with the three chemotherapy regimens
Time frame: From the date of informed consent signature to 28 days after the last drug administration
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 Mar 2017.
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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.
Steven LE GOUILL, Professor principal investigator
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Torisel dose 15 mg and R-CHOP, Torisel dose 15 mg and R-FC and Torisel dose 15 mg and R-DHA in people with Mantle Cell Lymphoma Refractory, run by The Lymphoma Academic Research Organisation at 11 sites 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 15 inclusion and 14 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Dose Limiting Toxicities (DLT) (time frame: 56 days). 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 Mar 2017.