Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Amino Acids

Acalabrutinib

Bendamustine Hydrochloride

Rituximab

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Bendamustine

Placebo

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.

Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.

Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.

Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.

Defined as the time from randomization until the date of death from any cause.

Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.

Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.

AstraZeneca

Acerta Pharma BV

Symptoms and General Pathology

Leukemia

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Lymphoma, B-Cell

Lymphoma, T-Cell, Cutaneous

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Follicular Lymphoma

B-cell Lymphoma

Hodgkin Lymphoma

Abexinostat

Histone Deacetylase Inhibitors

Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart ("BID"), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).

Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I.

PCI-24781

Thorsten Graef, MD

The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients.

Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma

Phase I/II Dose-Escalation Study of the Pan-Histone Deacetylase (HDAC) Inhibitor PCI-24781 in Lymphoma

Number of patients experienced DLT in each cohort

Pharmacyclics LLC.

Cohort 1(30 mg/m2, 5days/wk)/Phase I

Cohort 2(45 mg/m2, 5days/wk)/Phase I

Cohort 3(45 mg/m2, 7days/wk)/Phase I

Cohort 4(60 mg/m2,7days/wk)/Phase I

Follicular/Phase II

Mantle Cell Lymphoma/Phase II

Cohort 1(30 mg/m2, 5days/wk)/Phase 1

Cohort 2(45 mg/m2, 5days/wk)/Phase 1

Cohort 3(45 mg/m2, 7days/wk)/Phase 1

Cohort 4(60 mg/m2,7days/wk)/Phase 1

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Thorsten Graef

Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I

Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I

Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I

Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I

Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response

Follicular/Phase II (Efficacy)

Mantle Cell Lymphoma/Phase II (Efficacy)

Phase II: Overall Response Rate (CR+PR)

Cohort 1(30mg/m2,5days/wk)/Phase 1

Cohort 2(45mg/m2,5days/wk)/Phase 1

Cohort 3(45mg/m2,7days/wk)/Phase 1

Cohort 4(60mg/m2,7days/wk)/Phase 1

Overall Study

Leukemia, Lymphoid

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Atezolizumab

Antibodies

Durvalumab

Lenalidomide

Immunoglobulins

Ibrutinib

Angiogenesis Inhibitors

Growth Inhibitors

Participants assigned to Arm A will receive:

* Durvalumab 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and
* Lenalidomide orally at assigned dose levels (10 mg, 15 mg or 20 mg) once daily on Days 1 to 21 of:

  * Cycles 1 through 13 in indolent non-Hodgkin's lymphoma (NHL) or
  * All cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL
* Rituximab 375 mg/m² IV infusion every week in Cycle 1 (Days 2, 8, 15, 22) and on Day 1 of Cycles 2 through 5.

All treatment cycles were 28 days.

Participants assigned to Arm B will receive:

* Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13
* Ibrutinib orally at assigned dose levels (280 mg, 420 mg, or 560 mg) once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.

All treatment cycles were 28 days.

Participants assigned to Arm C will receive:

* Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13
* Rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose will be 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose)
* Bendamustine IV infusion at assigned dose levels (70 mg/m² or 90 mg/m²) on Days 1 and 2 of Cycles 1 through 6.

All treatment cycles were 28 days.

Participants assigned to Arm D will receive durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13. All treatment cycles were 28 days.

Administered as an IV infusion (250 mL) over approximately 1 hour in duration

Administered as a 30-minute intravenous infusion

Bristol-Myers Squibb

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

The study was to consist of 3 parts: dose-finding, dose-confirmation, and dose-expansion. In this study, 4 treatment arms were to be investigated:

* Arm A: durvalumab and lenalidomide ± rituximab
* Arm B: durvalumab and ibrutinib
* Arm C: durvalumab and rituximab ± bendamustine
* Arm D: durvalumab (monotherapy)

The study was to start with 3 dose-finding cohorts (Arms A, B, and C) and 1 dose-confirmation cohort (Arm D) in parallel. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms. For Arms A and C, prior to enrolling participants to receive all 3 drugs, the doublet combinations were to be evaluated. Once the doublet combinations were deemed tolerable, the eventual triplet combinations were to be tested.

On 05 September 2017, the US FDA issued a Partial Clinical Hold on the study Arm A. Following this Partial Clinical Hold no more participants were enrolled into study Arm A. Participants already enrolled and treated in Arm A who were receiving clinical benefit, based on the discretion of the investigator, could continue study treatment after being reconsented. Arm B and C completed dose confirmation. The dose expansion part of the study was not opened.

Within Arms A, B, and C participants on the dose-finding part were enrolled sequentially according to a 3+3 design. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms.

A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion • Grade 4 anemia, unexplained by underlying disease • Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours. Non-Hematologic DLT • Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management • Any treatment interruption greater than 2 weeks due to adverse event.

Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).

For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification) (Cheson, 2014). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percentage of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

Time to response was calculated as the time from first dose of study drug to the first response date (CR or PR for lymphoma participants and CR, CRi, nPR, PR, or PRL for CLL participants).

Duration of response is defined for responders only as the time from the first documented response (CR or PR for lymphoma participants or CR, CRi, nPR, PR, or PRL for CLL participants) to disease progression or death (from any cause). For participants with response but no progression, or death, duration of response was censored at the last date that the participant was known to be progression-free.

Progression-free survival was calculated as the time from first dose of study drug to the first documented progression or death (from any cause) during the entire efficacy evaluation period. For participants with no progression or death, PFS was censored at the last assessment date the participant was known to be progression-free.

Change from baseline in sPD-L1 could not be calculated as all post-baseline samples were below the lower limit of quantification (\<15.60 pg/mL).

Celgene

Participants received durvalumab (DUR) 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent non-Hodgkin's lymphoma (NHL) or for all cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL.

Part 1, Arm A: DUR 1500 mg + LEN 20 mg

Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 20 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab (RIT) 375 mg/m² IV infusion on Days 2, 8, 15, and 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Part 1, Arm A: DUR 1500 mg + LEN 20 mg + RIT 375 mg/m²

Participants received durvalumab (DUR) 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and lenalidomide (LEN) 10 mg orally once daily on Days 1 to 21 of Cycles 1 through 13 for participants with indolent NHL or until disease progression, unacceptable toxicity, or discontinuation for any other reason in participants with aggressive NHL, and rituximab 375 mg/m² IV infusion on Days 2, 8, 15, 22 of Cycle 1 and on Day 1 of every 28-day cycle from Cycles 2 through 5.

Part 1, Arm A: DUR 1500 mg + LEN 10 mg + RIT 375 mg/m²

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib (IBR) 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.

Part 1, Arm B: DUR 1500 mg + IBR 420 mg

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.

Part 1, Arm B: DUR 1500 mg + IBR 560 mg

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for participants with CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m²

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and bendamustine (BEN) 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6.

Part 1, Arm C: DUR 1500 mg + BEN 70 mg/m²

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²

Participants received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 90 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Part 1, Arm C: DUR 1500 mg + RIT 375 mg/m² + BEN 90 mg/m²

Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 420 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.

Part 2, Arm B CLL/SLL: DUR 1500 mg + IBR 420 mg

Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 and ibrutinib 560 mg orally once daily until disease progression, unacceptable toxicity or discontinuation for any other reason.

Part 2, Arm B MCL: DUR 1500 mg + IBR 560 mg

Participants with follicular lymphoma (FL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.

Part 2, Arm C FL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²

Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6.

Part 2 Arm C DLBCL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²

Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13, bendamustine 70 mg/m² IV infusion on Days 1 and 2 of Cycles 1 through 6, and rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose was 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose).

Part 2, Arm C CLL/SLL: DUR 1500 mg + RIT 375 mg/m² + BEN 70 mg/m²

Participants with follicular lymphoma received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.

Part 2, Arm D FL: DUR 1500 mg

Participants with diffuse large B-cell lymphoma (DLBCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.

Part 2, Arm D DLBCL: DUR 1500 mg

Participants with CLL or SLL received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.

Part 2, Arm D CLL/SLL: DUR 1500 mg

Participants with mantle cell lymphoma (MCL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.

Part 2, Arm D MCL: DUR 1500 mg

Participants with Hodgkin lymphoma (HL) received durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13.

Part 2, Arm D HL: DUR 1500 mg

Age, Customized

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Histology

ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: • 0 = Fully active, no restrictions; • 1 = Restricted activity but ambulatory, able to carry out work of a light nature; • 2 = Ambulatory and capable of all self-care but unable to carry out work activities; • 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; • 4 = Completely disabled, no selfcare, confined to bed or chair; • 5 = Dead

Eastern Cooperative Oncology Group ECOG) Performance Status

The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. As the result, the study was closed for further enrollment, and all participants were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All participants were followed for second primary malignancies (SPMs) for 5 years after the last participant has been enrolled as per protocol.

Bristol-Myers Squibb Study Director

The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).

For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.

For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².

DLT Evaluable population included participants in Arms A, B, and C of Part 1, who took at least one dose of study drug and completed the DLT evaluation through the end of DLT evaluation period, or participants who took at least one dose of study drug and experienced at least one DLT prior to completion of the DLT evaluation period.

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Any TEAE

TEAE Related to Any Study Drug

CTCAE Grade 3-4 TEAE

CTCAE Grade 3-4 TEAE Related to Any Study Drug

CTCAE Grade 5 TEAE

CTCAE Grade 5 TEAE Related to Any Study Drug

Serious TEAE

Serious TEAE Related to Any Study Drug

TEAE Leading to Discontinuation of Any Study Drug

TEAE Leading to Dose Modifications of Study Drug

The Safety population included all participants who received at least 1 dose of study drug.

Number of Participants With Treatment-emergent Adverse Events

The Efficacy Evaluable population includes all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV
Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma	NCT00724984	Lymphoma Hodgkin Disease Lymphoma, Non-H...	PCI-24781	18 Years -	Pharmacyclics LLC.
A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia	NCT02733042	Lymphoma Leukemia, Lymph...	Durvalumab Lenalidomide Rituximab Ibrutinib Bendamustine	18 Years -	Celgene
EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma	NCT00114738	Lymphoma, Mantl... Mantle Cell Lym...	Rituximab (R) EPOCH Bortezomib (B) Bortezomib Bortezomib or o...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma	NCT00114738	Lymphoma, Mantl... Mantle Cell Lym...	Rituximab (R) EPOCH Bortezomib (B) Bortezomib Bortezomib or o...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma	NCT00849654	B-Cell Lymphoma B-Cell Leukemia	PCI-32765	18 Years -	Pharmacyclics LLC.
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL	NCT02972840	Lymphoma, Mantl...	Acalabrutinib Bendamustine Rituximab Placebo	65 Years -	Acerta Pharma BV
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma	NCT00005780	Mantle Cell Lym... Lymphoma, Mantl...	EPOCH-R GM-CSF Idiotype vaccin...	18 Years -	National Institutes of Health Clinical Center (CC)
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma	NCT00005780	Mantle Cell Lym... Lymphoma, Mantl...	EPOCH-R GM-CSF Idiotype vaccin...	18 Years -	National Institutes of Health Clinical Center (CC)
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma	NCT00005780	Mantle Cell Lym... Lymphoma, Mantl...	EPOCH-R GM-CSF Idiotype vaccin...	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for lymphoma, mantle cell