| 1 |
NCT01472562 |
Active, not recruiting
Has Results |
Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma |
|
- Drug: lenalidomide
- Biological: rituximab
|
Interventional |
Phase 2 |
- Weill Medical College of Cornell University
- Celgene
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate
- 2-year Progression-free Survival
|
38 |
All |
18 Years and older (Adult, Senior) |
NCT01472562 |
1103011566 |
|
June 2011 |
April 2014 |
October 2022 |
November 16, 2011 |
March 27, 2018 |
April 7, 2017 |
- Moffitt Cancer Center
Tampa, Florida, United States - University of Chicago
Chicago, Illinois, United States - Weill Cornell Medical College
New York, New York, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 2 |
NCT02840539 |
Recruiting |
Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma |
|
- Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
|
Interventional |
Phase 2 |
- Seoul National University Hospital
- Consortium for Improving Survival of Lymphoma
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response
- Complete response
- Overall survival
- Progression-free survival
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT02840539 |
SNUH-1602-153-747 |
BATMAN |
October 11, 2016 |
February 2020 |
June 2025 |
July 21, 2016 |
November 1, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 3 |
NCT03323151 |
Recruiting |
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma |
|
- Drug: Ixazomib
- Drug: Ibrutinib
|
Interventional |
Phase 1
Phase 2 |
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Maximum Tolerated Dose (MTD)
- Phase II: Complete Response Rate
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- (and 3 more...)
|
84 |
All |
18 Years and older (Adult, Senior) |
NCT03323151 |
PrE0404
X16077 |
PrE0404 |
April 2018 |
January 2024 |
December 2024 |
October 26, 2017 |
March 15, 2018 |
|
- Reading Hospital/McGlinn Cancer Institute
West Reading, Pennsylvania, United States
|
| 4 |
NCT03016988 |
Not yet recruiting |
The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma |
|
- Drug: Bortezomib
- Drug: Fludarabine
- Drug: Cytarabine
|
Interventional |
Phase 2 |
- Tingbo Liu
- Union hospital of Fujian Medical University
- Fujian Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progress-free survival
- Overall response rate
|
50 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03016988 |
Fujian Medical University |
|
January 2017 |
December 2018 |
December 2020 |
January 11, 2017 |
January 11, 2017 |
|
|
| 5 |
NCT01439750 |
Active, not recruiting |
Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011) |
|
- Drug: Rituximab
- Drug: bortezomib
- Drug: Cladribine
|
Interventional |
Phase 1 |
- Milton S. Hershey Medical Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Outcome Dose Limiting Tolerability
- Secondary Outcome objective response rates
|
13 |
All |
18 Years and older (Adult, Senior) |
NCT01439750 |
PSHCI 10-011 |
|
May 2012 |
August 2018 |
August 2020 |
September 23, 2011 |
August 7, 2017 |
|
- Penn State Cancer Institute
Hershey, Pennsylvania, United States - Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
|
| 6 |
NCT00581854 |
Completed
Has Results |
Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma |
|
- Drug: modified Hyper-CVAD
|
Interventional |
Phase 2 |
- University of Wisconsin, Madison
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Response Rate to Induction Therapy
|
22 |
All |
18 Years and older (Adult, Senior) |
NCT00581854 |
HO00401 |
|
June 2000 |
June 2006 |
March 2010 |
December 28, 2007 |
July 21, 2014 |
July 21, 2014 |
- UWCCC
Madison, Wisconsin, United States
|
| 7 |
NCT00581776 |
Completed
Has Results |
Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma |
|
- Drug: Bortezomib
- Drug: Rituximab
- Drug: Cyclophosphamide
- (and 3 more...)
|
Interventional |
Phase 2 |
- University of Wisconsin, Madison
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
- Complete Response Rate (CR) at the End of Induction Chemotherapy
- 3 Year Progression Free Survival
- 3 Year Overall Survival (OS)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00581776 |
HO05401 |
|
May 2005 |
November 2012 |
May 2015 |
December 28, 2007 |
June 20, 2016 |
February 15, 2011 |
- University Of Wisconsin Cancer Center
Madison, Wisconsin, United States
|
| 8 |
NCT02735876 |
Withdrawn |
A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma |
|
- Drug: acalabrutinib
- Drug: ibrutinib
- Drug: rituximab
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2.
- Investigator-assessed progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
- Investigator-assessed overall response rate (ORR) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
- (and 2 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02735876 |
ACE-LY-309 |
|
May 2016 |
June 2020 |
|
April 13, 2016 |
May 13, 2016 |
|
|
| 9 |
NCT00843050 |
Terminated
Has Results |
A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma |
|
|
Interventional |
Phase 2 |
- Piramal Enterprises Limited
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best Overall Objective Response Rate
- Duration of Response
- Time to Progression
|
13 |
All |
18 Years and older (Adult, Senior) |
NCT00843050 |
P276-00/23/08 |
|
November 2009 |
February 2011 |
August 2012 |
February 13, 2009 |
July 27, 2012 |
July 27, 2012 |
- Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona
Phoenix, Arizona, United States - Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona
Scottsdale, Arizona, United States - College of Medicine, Mayo Clinic
Rochester, Minnesota, United States - (and 17 more...)
|
| 10 |
NCT03494179 |
Recruiting
New |
A Study to Investigate ICP-022 in Chinese Patients With R/R Mantle Cell Lymphoma (MCL) |
|
|
Interventional |
Phase 1
Phase 2 |
- Beijing InnoCare Pharma Tech Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- overall response rate (ORR)
- Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I
- complete response rate (CRR)
- (and 10 more...)
|
120 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03494179 |
ICP-CL-00102 |
|
April 2, 2018 |
June 30, 2019 |
December 31, 2020 |
April 11, 2018 |
April 11, 2018 |
|
- Anhui Province Cancer Hospital
Hefei, Anhui, China - Peking University Third Hospital
Beijing, Beijing, China - Peking Union Medical College Hospital
Beijing, Beijing, China - (and 28 more...)
|
| 11 |
NCT01457144 |
Completed |
Study of Mantle Cell Lymphoma Treatment by RiBVD |
|
|
Interventional |
Phase 2 |
- French Innovative Leukemia Organisation
- Lymphoma Study Association
- Janssen-Cilag Ltd.
- (and 3 more...)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement of progression-free survival (PFS)
- Overall and complete response rate after 4 cures and 6 cures
- Residual disease evaluated by molecular biology
- (and 5 more...)
|
76 |
All |
65 Years to 85 Years (Adult, Senior) |
NCT01457144 |
Manteau RiBVD |
RIBVD |
October 2011 |
September 2014 |
March 2016 |
October 21, 2011 |
March 16, 2016 |
|
- Valerie ROLLAND NEYRET
Grenoble, France
|
| 12 |
NCT03112174 |
Recruiting |
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) |
|
- Drug: Ibrutinib
- Drug: Venetoclax
- Drug: Placebo Oral tablet to match Venetoclax
|
Interventional |
Phase 3 |
- Pharmacyclics LLC.
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Occurrence of Tumor Lysis Syndrome (TLS)
- Occurrence of Dose Limiting Toxicities (DLT)
- Progression-free Survival (PFS)
|
287 |
All |
18 Years and older (Adult, Senior) |
NCT03112174 |
PCYC-1143-CA |
|
May 12, 2017 |
March 2022 |
September 2022 |
April 13, 2017 |
April 4, 2018 |
|
- City of Hope
Duarte, California, United States - Ingalls Memorial Hospital
Harvey, Illinois, United States - Norton Cancer Institute
Louisville, Kentucky, United States - (and 35 more...)
|
| 13 |
NCT02356458 |
Recruiting |
Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma |
|
- Drug: Ibrutinib
- Drug: bortezomib
|
Interventional |
Phase 1
Phase 2 |
- Swiss Group for Clinical Cancer Research
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Dose limiting toxicity (DLT) observed during the first cycle of trial treatment
- Phase II: Overall response (OR) (combination therapy)
|
73 |
All |
18 Years and older (Adult, Senior) |
NCT02356458 |
SAKK 36/13
2014-003893-17
SNCTP000001235 |
|
August 2015 |
March 2019 |
December 2021 |
February 5, 2015 |
March 30, 2018 |
|
- Klinikum der Universität München
München, Germany - European Institute of Oncology
Milano, Italy - Kantonsspital Aarau
Aarau, Switzerland - (and 10 more...)
|
| 14 |
NCT02858258 |
Recruiting |
ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma |
|
- Drug: R-CHOP/R-DHAP
- Drug: Ibrutinib (Induction)
- Drug: ASCT conditioning
- Drug: Ibrutinib (Maintenance)
|
Interventional |
Phase 3 |
- Prof. Dr. M. Dreyling (co-chairman)
- Klinikum der Universitaet Muenchen
- European Mantle Cell Lymphoma Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Failure Free Survival
- Overall Survival
- Number of participants with treatment-related adverse events as assessed by CTC Version 4.03
- (and 3 more...)
|
870 |
All |
18 Years to 65 Years (Adult) |
NCT02858258 |
TRIANGLE |
|
July 2016 |
May 2021 |
May 2026 |
August 8, 2016 |
December 19, 2017 |
|
- Aalborg University Hospital, Dept of Hematology
Aalborg, Denmark - Aarhus University Hospital, Dept of Hematology
Aarhus C, Denmark - Rigshospitalet, Clinic of Hematology
Copenhagen, Denmark - (and 109 more...)
|
| 15 |
NCT02471391 |
Recruiting |
ABT-199 & Ibrutinib in Mantle Cell Lymphoma (AIM) |
|
- Drug: ABT-199
- Drug: Ibrutinib
|
Interventional |
Phase 2 |
- Peter MacCallum Cancer Centre, Australia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete response measured using IWG at 16 weeks
- Completing 4, 16, 28, 40 and 56 weeks of treatment
- Toxicities measured using CTCAE version 4
- (and 7 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT02471391 |
14/148 |
AIM |
June 2015 |
June 2017 |
June 2018 |
June 15, 2015 |
August 31, 2015 |
|
- Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia - Royal Melbourne Hospital
Melbourne, Victoria, Australia
|
| 16 |
NCT02728531 |
Recruiting |
Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma |
|
- Drug: Bendamustine
- Drug: Rituximab
- Drug: Cytarabine
- (and 4 more...)
|
Interventional |
Phase 1 |
- Washington University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Stem cell mobilization success rate
- Overall response rate
- Pre-transplant complete response rate (CRR)
- (and 3 more...)
|
15 |
All |
18 Years to 65 Years (Adult) |
NCT02728531 |
201603149 |
|
April 18, 2016 |
September 30, 2018 |
April 30, 2023 |
April 5, 2016 |
February 6, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
| 17 |
NCT02896582 |
Recruiting |
Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance |
|
- Drug: Obinutuzumab
- Drug: Dexamethasone
- Drug: Aracytine
- (and 4 more...)
|
Interventional |
Phase 2 |
- The Lymphoma Academic Research Organisation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Molecular Residual Disease (MRD) in bone marrow after 4 cycles of GA-DHAP
- Response according to Cheson 99
- Overall response rate (ORR)
- (and 14 more...)
|
83 |
All |
18 Years to 65 Years (Adult) |
NCT02896582 |
LyMa101 |
LyMa101 |
October 2016 |
March 2019 |
March 2025 |
September 12, 2016 |
March 7, 2018 |
|
- CHU d'Amiens
Amiens, France - CHU d'Angers
Angers, France - CH d'Avignon
Avignon, France - (and 27 more...)
|
| 18 |
NCT02558816 |
Recruiting |
A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients |
|
- Drug: Ibrutinib + GA101 +GDC-0199
|
Interventional |
Phase 1
Phase 2 |
- Nantes University Hospital
- Janssen, LP
- Roche Pharma AG
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Step A : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib during the first cycle of treatment
- Step B : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib plus GDC-0199 during the cycle 2 in terms of Dose-Limiting Toxicities (DLTs) of the studied combination to establish the Recommended Phase 2 Dose (RP2D).
- Step C : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib and GDC-0199 at the end of the cycle 2.
- (and 6 more...)
|
48 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02558816 |
RC14_0048
2014-003740-13 |
OAsIs |
October 14, 2015 |
April 2018 |
October 2023 |
September 24, 2015 |
August 14, 2017 |
|
- CHU Angers
Angers, France - CHU de Dijon
Dijon, France - Hôpital Claude Huriez - CHRU de Lille
Lille, France - (and 6 more...)
|
| 19 |
NCT01776840 |
Active, not recruiting |
A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma |
|
- Drug: Bendamustine
- Drug: Rituximab
- Drug: Ibrutinib
- Drug: Placebo
|
Interventional |
Phase 3 |
- Janssen Research & Development, LLC
- Pharmacyclics LLC.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Progression-free survival
- Overall survival
- Overall response rate
- (and 10 more...)
|
524 |
All |
65 Years and older (Adult, Senior) |
NCT01776840 |
CR100967
PCI-32765MCL3002
U1111-1137-0389
2012-004056-11 |
|
May 16, 2013 |
November 15, 2019 |
October 12, 2021 |
January 28, 2013 |
February 8, 2018 |
|
- Tucson, Arizona, United States
- Burbank, California, United States
- La Jolla, California, United States
- (and 199 more...)
|
| 20 |
NCT00786851 |
Completed |
Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL) |
|
- Drug: Lenalidomide and Dexametasone
|
Interventional |
Phase 2 |
- Fondazione Italiana Linfomi ONLUS
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To explore the antitumor activity of the association of Len-Dex in term of overall (OR) and complete response (CR) in patients with relapsed/refractory MCL
- To explore the safety profile;
- To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy;
- To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS).
|
33 |
All |
18 Years and older (Adult, Senior) |
NCT00786851 |
IIL LEN-DEX MCL 07
EudraCT Number 2008−000044−14 |
|
July 2008 |
July 2010 |
August 2011 |
November 6, 2008 |
August 17, 2016 |
|
- Ospedale SS. Antonio Biagio e Cesare Arrigo
Alessandria, Italy - Centro diriferimento oncologico
Aviano (PN), Italy - Ematologia Spedali Civili
Brescia, Italy - (and 14 more...)
|
| 21 |
NCT02632396 |
Recruiting |
Ixazomib & Rituximab After Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma in Remission |
|
- Drug: Ixazomib
- Biological: Rituximab
|
Interventional |
Phase 1
Phase 2 |
- Emory University
- Millennium Pharmaceuticals, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Recommended phase 2 dose of ixazomib, defined as the dose where 1 or fewer of 6 treated patients experience a dose limiting toxicity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Phase I)
- Progression-free survival (PFS), defined as the percentage of patients who have received at least one dose of study therapy who are alive and free of disease progression or relapse at 1-year post autologous stem cell transplant (Phase II)
- Conversion rate from MRD positive to MRD negative during therapy (Phase I & II)
- (and 8 more...)
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT02632396 |
IRB00076016
NCI-2015-01943
X16058
Winship2839-15 |
|
March 2016 |
March 2020 |
March 2022 |
December 16, 2015 |
March 23, 2018 |
|
- Emory University/Winship Cancer Institute
Atlanta, Georgia, United States - Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
|
| 22 |
NCT00847223 |
Terminated |
Efficacy and Safety of the Farnesyl-transferase Inhibitor (Tipifarnib) in Mantle Cell Lymphoma |
|
- Drug: ZARNESTRA (Tipifarnib)
|
Interventional |
Phase 2 |
- Lymphoma Study Association
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy measured by evaluation of the overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Zarnestra® as single agent, according to criteria based on those developed by Cheson and al.
- To determine the overall CR rate (CR + CRu),progression-free survival (PFS), overall survival, to evaluate the safety and tolerability of Zarnestra®
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT00847223 |
MCL06-1 |
|
June 2007 |
March 2009 |
|
February 19, 2009 |
March 4, 2011 |
|
|
| 23 |
NCT01599949 |
Completed |
A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy |
|
|
Interventional |
Phase 2 |
- Janssen Research & Development, LLC
- Pharmacyclics LLC.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate
- Overall survival rate
- Progression-free survival rate
- (and 7 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT01599949 |
CR100847
PCI-32765MCL2001
2012-000711-88 |
|
August 2012 |
May 2015 |
May 2015 |
May 16, 2012 |
June 1, 2016 |
|
- La Jolla, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- (and 54 more...)
|
| 24 |
NCT01646021 |
Completed
Has Results |
Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy |
|
- Drug: Ibrutinib
- Drug: Temsirolimus
|
Interventional |
Phase 3 |
- Janssen Research & Development, LLC
- Pharmacyclics LLC.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Response Rate (ORR)
- Overall Survival (OS)
- (and 5 more...)
|
280 |
All |
18 Years and older (Adult, Senior) |
NCT01646021 |
CR100848
PCI-32765MCL3001
2012-000601-74
U1111-1135-6930 |
|
December 10, 2012 |
June 5, 2015 |
December 15, 2016 |
July 20, 2012 |
January 19, 2018 |
March 1, 2017 |
- Antwerpen, Belgium
- Brugge, Belgium
- Brussels, Belgium
- (and 95 more...)
|
| 25 |
NCT02446236 |
Recruiting |
Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma |
|
- Drug: Lenalidomide
- Drug: Ibrutinib
- Drug: Rituximab
|
Interventional |
Phase 1 |
- Hackensack University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the MTD through number of patients with adverse events
- assess safety profile through review of adverse events
|
38 |
All |
18 Years and older (Adult, Senior) |
NCT02446236 |
Pro 5444 |
|
June 18, 2015 |
April 2018 |
June 2020 |
May 18, 2015 |
August 10, 2017 |
|
- The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
|
| 26 |
NCT01833039 |
Completed |
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma |
- Relapsed or Refractory Mantle Cell Lymphoma
|
|
Interventional |
Phase 4 |
- Janssen Biotech, Inc.
- Pharmacyclics LLC.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Patients With Treatment Emergent Adverse Experiences during the study.
|
163 |
All |
18 Years and older (Adult, Senior) |
NCT01833039 |
CR101862
PCI-32765MCL4001 |
|
May 15, 2013 |
August 28, 2017 |
August 28, 2017 |
April 16, 2013 |
February 5, 2018 |
|
- Phoenix, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- (and 49 more...)
|
| 27 |
NCT01578343 |
Terminated |
Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma |
|
- Drug: Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat
|
Interventional |
Phase 2 |
- Samsung Medical Center
- Seok Jin Kim
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 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
|
20 |
All |
19 Years to 75 Years (Adult, Senior) |
NCT01578343 |
SMC2011-11-102-001 |
ZOLINZA |
June 2012 |
September 2015 |
February 2016 |
April 16, 2012 |
April 15, 2016 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
| 28 |
NCT01739309 |
Active, not recruiting |
Study of LY2835219 for Mantle Cell Lymphoma |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Complete Response unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)
- Proportion of Participants who Achieve Best Overall Disease Response of CR, CRu or PR
- Duration of Response
- (and 11 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01739309 |
13269
I3Y-MC-JPBB
2012-003614-14 |
|
March 2013 |
September 2015 |
March 2018 |
December 3, 2012 |
March 9, 2017 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille, France - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pessac, France - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Homburg, Germany - (and 4 more...)
|
| 29 |
NCT00878254 |
Recruiting |
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma |
|
- Biological: G-CSF
- Drug: Rituximab
- Drug: Cyclophosphamide
- (and 8 more...)
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of Progression-Free Survival (PFS)
- Rate of Overall Survival (OS)
- Rate of Response to Protocol Therapy
- Rate of Treatment-Related Toxicity in Study Participants
|
22 |
All |
19 Years to 72 Years (Adult, Senior) |
NCT00878254 |
20080803
SCCC-2008043 |
|
March 25, 2009 |
December 2019 |
December 2019 |
April 8, 2009 |
February 8, 2018 |
|
- University of Miami
Miami, Florida, United States
|
| 30 |
NCT01322776 |
Unknown † |
Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma |
- Mantle Cell Lymphoma Recurrent
|
- Drug: Combination of Bortezomib, Fludarabine and Cyclophosphamide
|
Interventional |
Phase 1
Phase 2 |
- Sun Yat-sen University
- Fudan University
- Zhejiang University
- (and 5 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical efficacy will be assessed according to the CT scan and bone marrow aspirate and biopsy
- Maximum Tolerated Dose（MTD）of Cyclophosphamide
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT01322776 |
Vel-FC-4003 |
|
March 2011 |
October 2013 |
October 2013 |
March 25, 2011 |
March 25, 2011 |
|
- SunYat-sen University Cancer Centre
Guang Zhou, Guang Dong, China
|
| 31 |
NCT00586755 |
Completed |
Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma |
|
- Procedure: Intensive Induction-BMT
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease Free Survival (DFS)
- Progression Free Survival (PFS)
- Response to the induction regimen
- (and 3 more...)
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT00586755 |
2165 |
|
February 1998 |
October 2007 |
November 2008 |
January 4, 2008 |
July 18, 2014 |
|
|
| 32 |
NCT01661881 |
Active, not recruiting
Has Results |
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma |
|
- Drug: Rituximab
- Drug: Bendamustine
- Drug: Cytarabine
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Remission (CR) Rate After 6 Cycles
- 1 Year Progression-Free Survival
- Autologous Stem Cell Transplant (ASCT) Rate
|
23 |
All |
18 Years to 69 Years (Adult, Senior) |
NCT01661881 |
12-168 |
|
August 2012 |
February 2015 |
March 2019 |
August 10, 2012 |
February 27, 2018 |
January 12, 2017 |
- Massachusetts General Hospital
Boston, Massachusetts, United States - Brigham and Women's Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 33 |
NCT01652144 |
Completed |
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma |
|
|
Interventional |
Phase 2 |
- NCIC Clinical Trials Group
- Astex Pharmaceuticals
- Canadian Cancer Trials Group
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy
- Severity of toxicity
- Time to progression
- Response duration
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT01652144 |
I194 |
|
August 2012 |
December 2014 |
February 2015 |
July 27, 2012 |
October 26, 2016 |
|
- CancerCare Manitoba
Winnipeg, Manitoba, Canada - QEII Health Sciences Centre
Halifax, Nova Scotia, Canada - Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada - (and 3 more...)
|
| 34 |
NCT00633594 |
Completed
Has Results |
Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma |
|
- Drug: Rituximab
- Drug: Bortezomib
- Drug: Lenalidomide
|
Interventional |
Phase 1
Phase 2 |
- SCRI Development Innovations, LLC
- Millennium Pharmaceuticals, Inc.
- Celgene
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants
- Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II
- Overall Response Rate (ORR) of Phase I and Phase II Participants
- (and 9 more...)
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT00633594 |
SCRI LYM 58 |
|
June 2008 |
April 2015 |
November 2016 |
March 12, 2008 |
January 31, 2017 |
January 31, 2017 |
- Providence Medical Group
Terre Haute, Indiana, United States - RHHP/ Hope Cancer Center
Terre Haute, Indiana, United States - St. Louis Cancer Care
Chesterfield, Missouri, United States - (and 4 more...)
|
| 35 |
NCT01497275 |
Terminated
Has Results |
Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma |
|
- Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
|
Interventional |
Phase 2 |
- Duke University
- Spectrum Pharmaceuticals, Inc
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response Rate (Complete Response + Partial Response)
- Number of Participants With Progression Free Survival
- Overall Survival at 1 Year
- Overall Survival at 5 Year
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT01497275 |
Pro00032517 |
|
February 2012 |
May 2014 |
May 2014 |
December 22, 2011 |
July 15, 2015 |
June 4, 2015 |
- Duke University Medical Center
Durham, North Carolina, United States
|
| 36 |
NCT00963534 |
Completed |
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. |
|
- Drug: lenalidomide, bendamustine, rituximab
|
Interventional |
Phase 1
Phase 2 |
- Lund University Hospital
- Mundipharma Pte Ltd.
- Celgene
- Roche Pharma AG
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD of lenalidomide (phase I) Progression free survival (phase II)
|
51 |
All |
65 Years and older (Adult, Senior) |
NCT00963534 |
NLG-MCL4 |
LENA-BERIT |
September 2009 |
August 2017 |
August 2017 |
August 21, 2009 |
March 12, 2018 |
|
- Herlev Hospital
Copenhagen, Denmark - Rigshospitalet, Department of Hematology
Copenhagen, Denmark - Århus University Hospital
Århus, Denmark - (and 14 more...)
|
| 37 |
NCT02717624 |
Active, not recruiting |
A Study of Acalabrutinib (ACP-196) in Combination With Bendamustine and Rituximab in Subjects With Mantle Cell Lymphoma |
- Mantle Cell Lymphoma (MCL)
|
- Drug: acalabrutinib in combination with BR
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT02717624 |
ACE-LY-106 |
|
February 2016 |
February 2021 |
June 2021 |
March 24, 2016 |
February 20, 2018 |
|
- Whittier, California, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- (and 15 more...)
|
| 38 |
NCT00285389 |
Completed |
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years |
|
- Drug: Adriblastin
- Drug: dexamethasone
- Drug: Chlorambucil
- (and 5 more...)
|
Interventional |
Phase 2 |
- French Innovative Leukemia Organisation
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- failure event free survival at 3 years
- Response rate after 4 R-(VAD+C) cycles
- Incident of Molecular residual disease on blood, marrow and stem cell collection
- (and 3 more...)
|
39 |
All |
18 Years to 65 Years (Adult) |
NCT00285389 |
MANTEAU 2001 |
|
February 2002 |
December 2005 |
December 2008 |
February 2, 2006 |
February 12, 2009 |
|
- Regional university hospital
Besancon, France - Regional university hospital
Rennes, France - REgional Hospital
Tours, France
|
| 39 |
NCT02213926 |
Active, not recruiting |
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma |
- Mantle Cell Lymphoma (MCL)
|
- Drug: ACP-196 (acalabrutinib)
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with previously treated MCL.
|
124 |
All |
18 Years and older (Adult, Senior) |
NCT02213926 |
ACE-LY-004 |
|
March 2015 |
February 2017 |
September 2019 |
August 12, 2014 |
August 1, 2017 |
|
- New York, New York, United States
- Plymouth, United Kingdom
|
| 40 |
NCT01504776 |
Completed |
Phase I Study of Panobinostat + Bortezomib for Relapsed and/or Refractory Mantle Cell Lymphoma (MCL) |
|
- Drug: Panobinostat
- Drug: Bortezomib
|
Interventional |
Phase 1 |
- Anand Jillella
- Novartis Pharmaceuticals
- Augusta University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
- Observe the activity of the combination against Mantle Cell Lymphoma (MCL) in patients treated in this Phase I study.
|
3 |
All |
18 Years and older (Adult, Senior) |
NCT01504776 |
CLBH589BUS48T |
BUS48T |
April 2011 |
September 2014 |
September 2014 |
January 5, 2012 |
September 19, 2014 |
|
- Georgia Regents University
Augusta, Georgia, United States
|
| 41 |
NCT01437709 |
Active, not recruiting |
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant |
|
- Biological: Ofatumumab (This arm is closed)
- Other: Ofatumumab + Bendamustine
|
Interventional |
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- single agent efficacy (as determined by response rate)
- the efficacy (as determined by response rate) of the combination ofatumumab + Bendamustine
- Overall Survival (OS)
- (and 3 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01437709 |
11-050 |
|
September 2011 |
September 2018 |
September 2018 |
September 21, 2011 |
December 2, 2017 |
|
- Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - Memorial Sloan Kettering West Harrison
Harrison, New York, United States - (and 3 more...)
|
| 42 |
NCT01484093 |
Active, not recruiting |
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma |
|
- Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
|
Interventional |
Phase 1
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- GlaxoSmithKline
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- maximum tolerated dose (MTD)
- 3 year Event Free Survival (EFS)
- 3-year Event Free Survival (EFS)
- (and 2 more...)
|
96 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01484093 |
11-095 |
|
November 2011 |
November 2018 |
November 2018 |
December 2, 2011 |
September 8, 2017 |
|
- Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States - (and 2 more...)
|
| 43 |
NCT00946374 |
Unknown † |
Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma |
|
- Drug: Immunochemotherapy
- Drug: High-dose BEAM plus autologous SCT
- Other: HLA-identical allogenic SCT
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 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
|
20 |
All |
18 Years to 55 Years (Adult) |
NCT00946374 |
L-149/2003
BfArM: A-7140-00-37/4021157 |
HD-MCL2003 |
July 2004 |
December 2010 |
June 2011 |
July 27, 2009 |
July 27, 2009 |
|
- University Hospital
Heidelberg, Germany
|
| 44 |
NCT01111188 |
Active, not recruiting |
Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma |
|
- Drug: PD 0332991
- Drug: bortezomib
|
Interventional |
Phase 1 |
- Weill Medical College of Cornell University
- Millennium Pharmaceuticals, Inc.
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of maximum tolerated dose (MTD) of PD 0332991 in combination with bortezomib in patients with recurrent mantle cell lymphoma
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01111188 |
0903010300 |
|
June 2010 |
January 15, 2023 |
January 15, 2024 |
April 27, 2010 |
January 31, 2018 |
|
- Weill Cornell Medical College
New York, New York, United States
|
| 45 |
NCT01236391 |
Completed
Has Results |
Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) |
|
|
Interventional |
Phase 2 |
- Pharmacyclics LLC.
- Janssen Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving Response
- Number of Participants With Treatment Emergent Adverse Events (AEs)
- PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
- Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score
|
115 |
All |
18 Years and older (Adult, Senior) |
NCT01236391 |
PCYC-1104-CA
PCI-32765 |
PCYC-1104-CA |
February 2011 |
January 2014 |
January 2014 |
November 8, 2010 |
August 28, 2015 |
March 13, 2015 |
- Stanford University School of Medicine
Stanford, California, United States - Hackensack University Medical Center
Hackensack, New Jersey, United States - Cll Research and Treatment Program
New Hyde Park, New York, United States - (and 15 more...)
|
| 46 |
NCT00505232 |
Completed |
Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02) |
|
- Drug: Y-90 Ibritumomab tiuxetan
|
Interventional |
Phase 2 |
- CABYC
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment safety
- Feasibility of proposed treatment scheme.
- Efficacy based on response rate: overall, partial and complete response.
- (and 2 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00505232 |
GELTAMO-LCM-04-02
2005-004400-37 |
LCM-04-02 |
January 2006 |
March 2010 |
May 2011 |
July 23, 2007 |
January 2, 2012 |
|
- Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain - Hospital Marques de Valdecilla
Santander, Cantabria, Spain - Hospital del Mar
Barcelona, Cataluña, Spain - (and 13 more...)
|
| 47 |
NCT00119730 |
Completed |
Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma |
|
- Drug: Fludarabine
- Drug: Mitoxantrone
- Drug: Rituximab
- Drug: Zevalin
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
- Biogen
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective is to determine the response rate to two cycles of FMR + Zevalin in patients with relapsed mantle cell lymphoma, using a two-stage design.
- To describe the progression-free survival
- To determine the safety of FMR + Zevalin in these subjects
- To determine the impact of Zevalin on minimal residual disease in subjects with relapsed mantle cell lymphoma
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00119730 |
04-251 |
|
February 2005 |
December 2006 |
December 2013 |
July 14, 2005 |
April 24, 2014 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 48 |
NCT02736617 |
Recruiting |
Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma |
- Recurrent Mantle Cell Lymphoma
- Refractory Mantle Cell Lymphoma
|
- Drug: Ibrutinib
- Other: Laboratory Biomarker Analysis
- Biological: Obinutuzumab
|
Interventional |
Phase 2 |
- OHSU Knight Cancer Institute
- Genentech, Inc.
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best overall response of CR/PR, measured from the start of treatment until disease progression/recurrence
- Incidence of toxicity, defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Progression free survival (PFS)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02736617 |
STUDY00015255
NCI-2016-00398
P30CA069533 |
|
May 2016 |
July 2021 |
|
April 13, 2016 |
September 25, 2017 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
| 49 |
NCT00514475 |
Completed |
Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma |
|
- Drug: 90Y-ibritumomab tiuxetan (Zevalin)
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC
- Safety
- TTF for CR patients receiving BEAM/BEAC
- (and 7 more...)
|
160 |
All |
18 Years to 65 Years (Adult) |
NCT00514475 |
2005-002003-17 |
|
November 2005 |
June 2009 |
June 2009 |
August 10, 2007 |
May 4, 2012 |
|
|
| 50 |
NCT02460276 |
Recruiting |
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma |
- Relapsed/Refractory Mantle Cell Lymphoma
|
- Drug: Lenalidomide
- Drug: Ibrutinib
- Drug: Rituximab
|
Interventional |
Phase 2 |
- Lund University Hospital
- Celgene
- Janssen, LP
- Nordic Lymphoma Group
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02460276 |
NLG-MCL6 |
PHILEMON |
April 2015 |
March 2019 |
March 2019 |
June 2, 2015 |
June 28, 2017 |
|
- Rigshospitalet
Copenhagen, Denmark - Helsinki University Hospital
Helsinki, Finland - Norwegian Radium Hospital
Oslo, Norway - (and 2 more...)
|
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