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NCT00553644

Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Completed Phase 2 Results posted Last updated 30 October 2018
What this trial tests

Phase 2 trial testing Bortezomib in Recurrent Mantle Cell Lymphoma in 53 participants. Completed in 21 January 2014.

Timeline
15 November 2007
Primary endpoint
31 December 2012
21 January 2014

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment53
Start date15 November 2007
Primary completion31 December 2012
Estimated completion21 January 2014
Sites82 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With an Overall Response Defined as Complete Response and Partial Response Primary · Duration of treatment (assessed up to 6 years)

Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.

GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)21
Incidence of Adverse Events Secondary · Duration of Treatment (up to 6 years)

Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting

Grade 2
GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)4
Grade 3
GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)29
Grade 4
GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)17
Grade 5
GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)1
Time to Progression Secondary · Assessed up to 6 years

Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.

GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)0.580.29 – 1.15
Overall Survival Secondary · Assessed up to 6 years

Overall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..

GroupValue95% CI
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)2.171.15 – 4.58

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Serious: 24/53 (45%)
Deaths:

Serious adverse events (91 terms)

ReactionSystemTreatment (Antiangiogenesi…
Platelet count decreasedInvestigations
Hemoglobin decreasedBlood and lymphatic system disorders
FatigueGeneral disorders
Leukocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
Serum calcium decreasedMetabolism and nutrition disorders
NauseaGastrointestinal disorders
DiarrheaGastrointestinal disorders
Serum albumin decreasedMetabolism and nutrition disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Creatinine increasedInvestigations
VomitingGastrointestinal disorders
FeverGeneral disorders
Lymphocyte count decreasedInvestigations
AnorexiaMetabolism and nutrition disorders
Peripheral sensory neuropathyNervous system disorders
Alanine aminotransferase increasedInvestigations
Alkaline phosphatase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Blood glucose increasedMetabolism and nutrition disorders
HypotensionVascular disorders
Abdominal painGastrointestinal disorders
Edema limbsGeneral disorders
Serum sodium decreasedMetabolism and nutrition disorders
DizzinessNervous system disorders
Other adverse events (131 terms — click to expand)

ReactionSystemTreatment (Antiangiogenesi…
Hemoglobin decreasedBlood and lymphatic system disorders
FatigueGeneral disorders
Platelet count decreasedInvestigations
Peripheral sensory neuropathyNervous system disorders
DiarrheaGastrointestinal disorders
Neutrophil count decreasedInvestigations
ConstipationGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
NauseaGastrointestinal disorders
Leukocyte count decreasedInvestigations
AnorexiaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
Lymphocyte count decreasedInvestigations
DizzinessNervous system disorders
Rash desquamatingSkin and subcutaneous tissue disorders
Blood glucose increasedMetabolism and nutrition disorders
Edema limbsGeneral disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Creatinine increasedInvestigations
PruritusSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
Serum albumin decreasedMetabolism and nutrition disorders
HypotensionVascular disorders
Serum calcium decreasedMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
Weight lossInvestigations
Serum sodium decreasedMetabolism and nutrition disorders
Peripheral motor neuropathyNervous system disorders
FeverGeneral disorders
Alkaline phosphatase increasedInvestigations
Serum phosphate decreasedMetabolism and nutrition disorders
Muscle weaknessMusculoskeletal and connective tissue disorders
SweatingSkin and subcutaneous tissue disorders
Vision blurredEye disorders
HeadacheNervous system disorders
InsomniaPsychiatric disorders
ChillsGeneral disorders
PneumoniaInfections and infestations
SinusitisInfections and infestations

Most-reported serious reactions: Platelet count decreased, Hemoglobin decreased, Fatigue, Leukocyte count decreased, Neutrophil count decreased, Serum calcium decreased, Nausea, Diarrhea.

Data from ClinicalTrials.gov NCT00553644 adverse events section.

Sponsor's own description

This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Therapeutic Activity of Lenalidomide in Mantle Cell Lymphoma and Indolent Non-Hodgkin's Lymphomas.
    Gunnellini M, Falchi L. · · 2012 · cited 6× · PMID 22761620 · DOI 10.1155/2012/523842

Verify or expand the search:

Other trials of Bortezomib

Trials testing the same drug.

Other recruiting trials for Recurrent Mantle Cell Lymphoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00553644.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing