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Mantle Medical Research Studies

Up-to-date List of Mantle Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Mantle Medical Research Studies

Rank Status Study
1 Recruiting Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
Interventions: Drug: PD 0332991;   Drug: bortezomib
Outcome Measure: Determination of maximum tolerated dose (MTD) of PD 0332991 in combination with bortezomib in patients with recurrent Mantle Cell lymphoma
2 Not yet recruiting Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
Intervention: Drug: Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat
Outcome Measures: To determine the efficacy of vorinostat plus FND as an induction treatment confirmed by CT or MRI (PET/CT as indicated);   To determine the efficacy of vorinostat maintenance treatment, survival outcome and toxicity of vorinostat/FND measured by CT or MRI scan, CTCAE ver 4.0
3 Recruiting Study of Mantle Cell Lymphoma Treatment by RiBVD
Condition: Mantle Cell Lymphoma
Intervention: Drug: RiBVD
Outcome Measures: Improvement of progression-free survival (PFS);   Overall and complete response rate after 4 cures and 6 cures;   Residual disease evaluated by molecular biology;   Intermediate response predictive factors study;   Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity;   Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index;   Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells;   Diagnostic PET scan results, at intermediate and final analysis
4 Recruiting An Open-label, Phase 2 Study of ACP 196 in Subjects With Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma (MCL)
Intervention: Drug: ACP-196
Outcome Measures: To Measure the Number of Participants with a Response to Study Drug;   Number of Participants With Treatment Emergent Adverse Events (AEs)
5 Recruiting EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma
Condition: Lymphoma, Mantle Cell
Interventions: Drug: bortezomib;   Other: clinical observation
Outcome Measures: Progression-free survival and overall survival 5 years after completion of study treatment;   Response at the end of dose-adjusted induction therapy;   Response and toxicity at the end of maintenance therapy;   Response and progression-free survival of bortezomib at disease progression in the observation treatment arm 5 years after completion of study treatment;   Time to non-protocol treatment in the maintenance and observation treatment arms 5 years after completion of study treatment;   Correlation of microarray and proteomic findings with clinical outcomes as measured by cDNA microarray 5 years after completion of study treatment
6 Recruiting Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)
Condition: Mantle Cell Lymphoma
Interventions: Drug: Rituximab;   Drug: bortezomib;   Drug: Cladribine
Outcome Measures: Primary Outcome Dose Limiting Tolerability;   Secondary Outcome objective response rates
7 Unknown  Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
Condition: Mantle-Cell Lymphoma
Interventions: Drug: Immunochemotherapy;   Drug: High-dose BEAM plus autologous SCT;   Other: HLA-identical allogenic SCT
Outcome Measures: Efficacy: ORR, OS, EFS;   Toxicity according to WHO-Grading;   GvL-effect after allogenic SCT;   Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT
8 Recruiting Phase II Study of Age‐Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
Intervention: Drug: Rituximab, Bendamustine, Cytarabine.
Outcome Measures: complete remission rate at the end of treatment;   Toxicity will be represented by the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity;   the rate of molecular response;   the progression-free survival (PFS);   the overall survival (OS);   the duration of responses (DOR);   the rate of completion of treatment;   the rate of dose reductions or delays
9 Recruiting Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Condition: Lymphoma, Mantle-cell
Intervention: Drug: Ibrutinib
Outcome Measures: Percentage of Participants With Overall Response;   Duration of Response;   Time to Response;   Overall Survival (OS);   Progression-free Survival (PFS);   Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs);   Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]);   Apparent Clearance (CL/F);   Minimum Observed Plasma Concentration (Cmin)
10 Recruiting Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma
Conditions: Follicular Lymphoma;   Mantle Cell Lymphoma
Intervention: Drug: Temsirolimus, Rituximab, Bendamustin
Outcome Measures: Phase I: MTD / Phase II: ORR;   Progression free survival
11 Recruiting Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma
Condition: CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
Intervention: Drug: rituximab
Outcome Measures: Progression free survival;   time to progression (TTP);   overall survival (OS);   response to treatment
12 Not yet recruiting Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Conditions: Contiguous Stage II Mantle Cell Lymphoma;   Noncontiguous Stage II Mantle Cell Lymphoma;   Stage I Mantle Cell Lymphoma;   Stage III Mantle Cell Lymphoma;   Stage IV Mantle Cell Lymphoma
Interventions: Drug: ibrutinib;   Other: laboratory biomarker analysis
Outcome Measures: Determine the progression-free survival (PFS) rate after 2 years;   Incidence of adverse events, defined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0;   Rate of conversion from Partial Response (PR) to Complete Response (CR);   Determine median Overall Survival (OS) after 4 years
13 Recruiting 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).
Condition: Mantle Cell Lymphoma Refractory
Interventions: Drug: Torisel and R-CHOP;   Drug: Torisel and R-FC;   Drug: Torisel and R-DHA
Outcome Measures: Incidence of Dose Limiting Toxicities (DLT);   Complete Response Rate(CR) after 4 cycles and at the end of treatment;   Progression-free survival (PFS);   Duration of Response;   Overall Response at the end of treatment;   Overall Survival (OS);   Safety of association Temsirolimus with the three chemotherapy regimens
14 Recruiting Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
Conditions: Contiguous Stage II Mantle Cell Lymphoma;   Noncontiguous Stage II Mantle Cell Lymphoma;   Recurrent Mantle Cell Lymphoma;   Stage I Mantle Cell Lymphoma;   Stage III Mantle Cell Lymphoma;   Stage IV Mantle Cell Lymphoma
Interventions: Drug: bortezomib;   Biological: rituximab;   Other: laboratory biomarker analysis;   Other: immunohistochemistry staining method;   Genetic: RNA analysis;   Genetic: gene expression analysis;   Genetic: DNA analysis;   Other: pharmacological study;   Other: pharmacogenomic studies
Outcome Measures: Disease-free survival rate;   Overall survival;   Time to treatment failure;   Toxicities of bortezomib and rituximab treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
15 Recruiting Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Conditions: Contiguous Stage II Mantle Cell Lymphoma;   Noncontiguous Stage II Mantle Cell Lymphoma;   Stage I Mantle Cell Lymphoma;   Stage III Mantle Cell Lymphoma;   Stage IV Mantle Cell Lymphoma
Interventions: Biological: ofatumumab;   Drug: cyclophosphamide;   Drug: dexamethasone;   Drug: doxorubicin hydrochloride;   Drug: vincristine sulfate;   Drug: cytarabine;   Procedure: autologous hematopoietic stem cell transplantation;   Drug: methotrexate;   Other: laboratory biomarker analysis
Outcome Measures: Proportion of patients experiencing a complete response;   Proportion of patients who experience complete remission as assessed by HSFCM;   Time-to-tumor progression (TTP);   Progression-free survival (PFS);   Overall survival (OS);   Frequency of toxicity events;   Correlation of minimal residual disease (MRD) with TTP, PFS, and OS;   Correlation of surface CD20 levels, Ki67, and additional cytogenetic abnormalities in pretreatment tumor biopsies with respect to ORR, CRR, TTP, PFS, and OS;   Relationship between proliferation signature and clinical outcome using quantitative real-time RT-PCR;   Change of serum C3, C4, and CH50 levels and correlation with ORR, CRR, MRR, TTP, PFS, and OS;   Ability of the induction and consolidation therapy to get 70% of patients to autologous stem cell transplantation
16 Recruiting Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
Condition: Mantle Cell Lymphoma
Interventions: Biological: Ofatumumab (This arm is closed);   Other: Ofatumumab + Bendamustine
Outcome Measures: single agent efficacy (as determined by response rate);   the efficacy (as determined by response rate) of the combination ofatumumab + Bendamustine;   Overall Survival (OS);   progression free survival (PFS);   Remission duration;   Response duration
17 Recruiting Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
Conditions: Carcinoma, Renal Cell, Advanced;   Lymphoma, Mantle-Cell;   Gastrointestinal Stroma Tumors
Interventions: Drug: Temsirolimus;   Drug: Sunitinib;   Drug: Axitinib
Outcome Measures: Safety: absolute and relative incidence of adverse events;   Efficacy: best response, progression-free survival, overall survival;   Safety: absolute and relative incidence of therapy interruption
18 Recruiting Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: Lenalidomide;   Drug: Rituximab
Outcome Measures: Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and Mantle Cell lymphoma (MCL);   Adverse Events;   Complete response rate;   Overall response rate;   Duration of response;   Duration of complete response;   Time to the next anti-lymphoma treatment;   Time to treatment failure;   Time to histological transformation
19 Recruiting CART-19 Immunotherapy in Mantle Cell Lymphoma
Conditions: Hematopoietic/Lymphoid Cancer;   Non-hodgkin Lymphoma,B Cell;   Mantle Cell Lymphoma
Intervention: Biological: anti-CD19-CAR vector-transduced T cells
Outcome Measures: Occurrence of study related adverse events;   Clinical responses to CART-19 cell therapy
20 Recruiting Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma
Conditions: Chronic Lymphocytic Leukemia;   Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue;   Nodal Marginal Zone Lymphoma;   Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;   Recurrent Grade 1 Follicular Lymphoma;   Recurrent Grade 2 Follicular Lymphoma;   Recurrent Mantle Cell Lymphoma;   Recurrent Marginal Zone Lymphoma;   Recurrent Small Lymphocytic Lymphoma;   Refractory Chronic Lymphocytic Leukemia;   Refractory Hairy Cell Leukemia;   Splenic Marginal Zone Lymphoma;   Waldenstrom Macroglobulinemia
Interventions: Drug: Alisertib;   Drug: Bortezomib;   Biological: Rituximab;   Other: Laboratory Biomarker Analysis
Outcome Measures: Recommended phase II dose of alisertib when combined with bortezomib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT);   Recommended phase II dose of bortezomib when combined with alisertib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a DLT;   Overall response rate (ORR) (complete response and partial response);   Progression free survival (PFS);   Duration of response (DOR);   Overall survival

These studies may lead to new treatments and are adding insight into Mantle etiology and treatment.

A major focus of Mantle research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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