Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Lenalidomide

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions

Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days

Catherine Diefenbach, MD

This trial is to assess the safety \& efficacy of the Combination of Pembrolizumab and Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.

There is an emerging clinical data to confirm that Programmed death-1 (PD-1)blockade is safe and viable in lymphoma.

The investigators hypothesize that the novel immune platform of pembrolizumab and lenalidomide, will be safe and well tolerated in patients with Relapsed Refractory (RR) Hodgkin Lymphoma (HL) and non-Hodgkin lymphoma (NHL) and that this combination will result in a complete response (CR) rate of 50% in patients with RR HL.

Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

A Phase I/II Study of the Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

Assessing the number of drug related adverse events at each dose level of lenalidomide

Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment

Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment.

Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and Overall Survival (OS).

Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and OS.

Merck Sharp & Dohme LLC

NYU Langone Health

The study was terminated before formal data collection could occur.

An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions

Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days

Pembrolizumab

Lenalidomide

Pembrolizumab and Lenalidomide

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Assess Safety and Tolerability of the Combination of Pembrolizumab and Lenalidomide (Number of Drug Related Adverse Events)

Estimate Overall Response Rate (ORR)

Estimate Complete Response Rate (CR)

Estimate Partial Response Rate (PR)

Estimate the ORR (CR, PR) for Combination Within & Across Dose Levels of Lenalidomide

Estimate Stable Disease (SD) for Combination Within & Across Dose Levels of Lenalidomide

Estimate Progression Free Survival (PFS) for Combination Within & Across Dose Levels of Lenalidomide

Estimate Clinical Benefit (Including SD) for the Combination

Estimate Progression Free Survival (PFS) for the Combination

Estimate Duration of Response (DOR) for the Combination

Overall Study

Antirheumatic Agents

Gemcitabine

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Immunomodulating Agents

Busulfan

Brentuximab Vedotin

Immunotoxins

Immunoconjugates

We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.

Brentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below:

* 42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
* 63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
* 84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1
* 105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1

Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.

Allogeneic Stem Cell Transplantation

Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide

Reduced Intensity Conditioning

Mitchell Cairo, MD

Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.

Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients

A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)

Patients will be followed for one year for adverse events related to the administration of study drug.

patients will be assessed for one year to determine survival status

A bank of from identified EBV positive donors will be established for potential use in current and future clinical trials in LMP-positive lymphomas. Annual review will occur to assess the feasibility of recruiting healthy donors to help build this cell line bank. If there are no cell lines developed within the first year, an alternative design may be considered.

St. Baldrick's Foundation

New York Medical College

Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 1

Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 2

Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 3

Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.

Phase 1, Cohort 4

JNJ-40346527 at the recommended dose determined in Phase 1

Phase 2

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

This is an open-label (individuals will know the identity of study treatments), dose-escalation study to evaluate the clinical efficacy, safety, and pharmacokinetics (PK; study of what the body does to a drug) of JNJ-40346527. Up to 38 subjects could be enrolled in the Phase 1 portion of the study and up to 30 subjects could be enrolled in the Phase 2 portion of the study (although planned, the study did not move forward to the Phase 2 portion). During the Phase 1 portion of the study, dose escalation of JNJ-40346527 will start at 150 mg (Cohort 1) once daily up to the maximum tolerated dose (MTD) or the highest planned dose (600 mg once daily); twice daily dosing may also be performed if deemed necessary. A Study Evaluation Team (SET) will review all available data after 1 cycle (21 days) of treatment for each cohort before any additional dose escalation occurs and will also determine the recommended Phase 2 dose for the expansion cohort. This study will consist of 3 periods: a screening period (from signing of informed consent until immediately before dosing), an open-label treatment period (from the first dose of study drug until the end-of-treatment visit), and a follow-up period (after the end-of-treatment visit). All patients will participate in the screening and treatment period. Patients will be administered JNJ-40346527 continuously until disease progression, or unacceptable toxicity (based on investigator assessment). The National Cancer Institute-Common Terminology Criteria for Adverse Events will be used to grade toxicity throughout the study. Disease response will be assessed according to the Revised Response Criteria for Malignant Lymphoma. Treatment will continue until disease progression or unacceptable toxicity (based on investigator assessment) occurs. Only patients who discontinue study drug before disease progression or discontinue due to treatment-related Grade 3 or higher toxicity will continue in the follow-up period. Serial PK samples will be collected in Cycle 1 as detailed in the protocol. Safety will be monitored throughout the study.

A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma

An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

Janssen Research & Development, LLC

Symptoms and General Pathology

Recurrence

INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.

Subjects allocated to Group B will be given INCB040093 BID in combination with itacitinib SR tablets. The dose of itacitinib will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.

INCB040093 Monotherapy

INCB040093

The dose of itacitinib will be given orally once daily (QD).

itacitinib

Peter Langmuir, MD

A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.

INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma

A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma

Evaluate the efficacy of INCB040093 as monotherapy and when given in combination with itacitinib by assessing the objective response rate (ORR) determined by an independent review committee.

Safety and tolerability of INCB040093 as monotherapy in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

Safety and tolerability of INCB040093 when given in combination with itacitinib in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

Complete Response is determined by the independent review committee and based on standard response criteria defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions.

Duration of response is defined as the time from the first assessment showing response (CR or PR) determined by the independent review committee to the first documented disease progression determined by the independent review committee or death due to any cause, whichever occurs first.

PFS was defined as the time from first dose to the first documented disease progression or relapse as assessed by independent review committee or death from any cause.

Incyte Corporation

Camidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles.

Camidanlumab Tesirine

The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

This is a phase 2, multi-center, open-label, single-arm study of efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin lymphoma. This study will enroll approximately 100 participants.

Camidanlumab Tesirine (ADCT-301) is an antibody drug conjugate (ADC), composed of the human monoclonal antibody, HuMax®-TAC, which is directed against human CD25. The antibody is conjugated through a protease cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin.

For each participant the study will include a screening period (of up to 28 days), a treatment period (cycles of 3 weeks), and a follow-up period (approximately every 12-week visits) for up to 3 years after treatment discontinuation.

Participants may continue treatment for up to 1 year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.

Additionally, patients benefiting clinically at 1 year may continue treatment after a case by case review with the Sponsor.

Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

DOR defined as the time from the first documentation of tumor response to disease progression or death.

CR rate defined as the number of treated participants with a best overall response (BOR) of CR.

RFS defined as the time from the documentation of CR to disease progression or death.

PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.

OS defined as the time from first dose of study drug until death due to any cause.

Participants receiving HSCT following camidanlumab tesirine, and without any other anticancer therapy in between, other than the therapies preparing for HSCT, were included in this analysis.

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

An SAE is defined as any adverse event (AE) that:

* results in death.
* is life threatening.
* requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE).
* results in persistent or significant disability/incapacity.
* is a congenital anomaly/birth defect.
* important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. Clinically significant changes in vital signs, clinical laboratory results, and electrocardiogram were reported as AEs.

The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

AI is the ratio of AUC from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.

Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment.

Participants were asked to indicate their health state on a VAS with scores ranging from 'the worst health you can imagine' (score 0) to 'the best health you can imagine' (score 100). Participants are asked to mark an "X" on the VAS to indicate their own health and then to report the score in a text box. Positive changes from Baseline represent an an improvement in heath.

The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General \[FACT-G\]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.

ADC Therapeutics S.A.

All AEs, AESIs, and SAEs regardless of relationship to study drug were reported from the time a participant signed the ICF until 30 days after the last dose of study drug. After 30 days following the last dose of study drug, only related SAEs were reported.

Participants received IV infusions of camidanlumab tesirine Q3W at a dose of 45 µg/kg on Day 1 of each cycle (one cycle = 21 days) for 2 cycles, followed by 30 µg/kg for subsequent cycles.

Age, Continuous

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Other

Missing

Race/Ethnicity, Customized

ECOG Score 0

ECOG Score 1

ECOG Score 2

ECOG Score 3

The ECOG Performance Status is a scale used to assess a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.

Eastern Cooperative Oncology Group (ECOG) Performance Status Score

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine. This population was used in the primary analyses of efficacy and safety.

Clinical Trials Information

Overall Response Rate (ORR)

Data from participants in the All-Treated Population who achieved ether CR or PR by independent reviewer.

Duration of Response (DOR)

CR Rate

Data from participants in the All-Treated Population who achieved CR.

Relapse-Free Survival (RFS)

Progression-Free Survival (PFS)

Overall Survival (OS)

Number of Participants Who Received Hematopoietic Stem Cell Transplant (HSCT)

Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

Number of Participants Who Experienced At Least One Serious Adverse Event (SAE)

Score 0

Score 1

Score 2

Score 3

All-Treated Population: All participants who received at least 1 dose of camidanlumab tesirine and reported ECOG data at EOT. This population was used in the primary analyses of efficacy and safety.

Number of Participants With ECOG Performance Status Score of 0-3 at the End of Trial (EOT)

Cycle 1

Cycle 2

PK Population: The analysis only included participants who received study drug and had at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid (measurable) assessment. Due to the nature of the studied drug (antibody-drug conjugate), some PK parameters frequently could not be measured, or could be measured only briefly.

Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody

Cmax of Camidanlumab Tesirine Unconjugated Warhead SG3199

Cmax of Camidanlumab Tesirine PBD-Conjugated Antibody

Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody

AUCtau For Camidanlumab Tesirine PBD-Conjugated Antibody

AUCtau For Camidanlumab Tesirine Unconjugated Warhead SG3199

Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma	NCT02875067	Relapsed Hodgki... Relapsed Non-Ho...	Pembrolizumab Lenalidomide	18 Years -	NYU Langone Health
Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients	NCT02098512	Hodgkin Lymphom...	Brentuximab Ved... Allogeneic Stem... Reduced Intensi...	- 45 Years	New York Medical College
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma	NCT01572519	Relapsed or Ref...	Phase 1, Cohort... Phase 1, Cohort... Phase 1, Cohort... Phase 1, Cohort... Phase 2	18 Years -	Janssen Research & Development, LLC
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma	NCT02456675	Refractory Hodg... Recurrent Adult...	INCB040093 Mono... INCB040093 itacitinib	18 Years -	Incyte Corporation
Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma	NCT02875067	Relapsed Hodgki... Relapsed Non-Ho...	Pembrolizumab Lenalidomide	18 Years -	NYU Langone Health
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma	NCT02456675	Refractory Hodg... Recurrent Adult...	INCB040093 Mono... INCB040093 itacitinib	18 Years -	Incyte Corporation
Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma	NCT02875067	Relapsed Hodgki... Relapsed Non-Ho...	Pembrolizumab Lenalidomide	18 Years -	NYU Langone Health
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma	NCT04052997	Relapsed Hodgki... Refractory Hodg...	Camidanlumab Te...	16 Years -	ADC Therapeutics S.A.

Spots Global Cancer Trial Database for relapsed hodgkin lymphoma