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).
NCT ID: NCT01389427
Last Updated: 2017-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
41 participants
INTERVENTIONAL
2011-11-30
2015-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Torisel 15 mg
Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 15 mg
Torisel dose 15 mg and R-CHOP
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-FC
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-DHA
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 25 mg
Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 25 mg
Torisel dose 25 mg and R-CHOP
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-FC
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-DHA
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 50 mg
Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 50 mg
Torisel dose 50 mg and R-CHOP
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-FC
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-DHA
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
Chemotherapy (R-CHOP, R-DHA or R-FC) associated to Torisel 75 mg
Torisel dose 75 mg and R-CHOP
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-FC
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 75 mg and R-DHA
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).
Interventions
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Torisel dose 15 mg and R-CHOP
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-FC
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-DHA
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-CHOP
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-CHOP
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-CHOP
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-FC
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-FC
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-FC
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-DHA
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-DHA
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-DHA
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ann Arbor Stage I-IV with at least one tumor site measurable,
3. Patients who received prior therapy (at least one but no more than three lines therapies) for Mantle Cell Lymphoma (MCL),
4. Aged ≥ 18 years,
5. ECOG performance status 0, 1 or 2,
6. Adequate hepatic and renal function :
* 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
7. 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,
8. Signed and date informed consent,
9. Life expectancy of ≥ 90 days (3 months)
Exclusion Criteria
2. Contraindication to any drug contained in the three chemotherapy regimens (R-CHOP, R-FC, R-DHA),
3. Tested positive for HIV,
4. Active Hepatitis B and/or C,
5. Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited, to active systemic fungal infection, diagnosis of fever and neutropenia,
6. Any serious active disease or co-morbid medical condition (according to investigator's decision),
7. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
8. Received a biological agent for anti-neoplastic intent within 30 days prior to the first dose of study drug,
9. Use of any standard or experimental anti-cancer drug therapy within 30 days prior to the first dose of study drug,
10. 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,
11. Left Ventricular Ejection Fraction \< 45% (calculated by echocardiographic or scintigraphic method),
12. Pregnancy or breast feeding women,
13. 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,
14. 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.
18 Years
ALL
No
Sponsors
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French Innovative Leukemia Organisation
OTHER
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Steven LE GOUILL, Professor
Role: PRINCIPAL_INVESTIGATOR
Locations
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CHU de Grenoble MICHALLON
Grenoble, Hôpital Nord 217, France
Hôtel Dieu - Université de Nantes
Nantes, Place Alexis Ricordeau, France
Hôpital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
Hôpital Saint-Eloi
Montpellier, , France
Hôpital Saint Louis
Paris, , France
Hôpital Necker
Paris, , France
Groupe hospitalier Sud Hôpital Haut-Lévêque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Pontchaillou
Rennes, , France
CHU de Tours - Hôpital Bretonneau
Tours, , France
Countries
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Other Identifiers
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T³
Identifier Type: -
Identifier Source: org_study_id
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