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Histone Methyltransferase Inhibitor
CC-99282 + Anti-Lymphoma Agents for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must not have
Impaired cardiac function or clinically significant cardiac disease
Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, CC-99282, for patients with certain types of lymphoma who haven't responded to other treatments. Researchers are finding the safest dose and checking if it works better alone or with other drugs.
Who is the study for?
This trial is for people with Non-Hodgkin's Lymphoma that has come back or hasn't responded to treatment. Participants should be fairly active and able to care for themselves (ECOG status 0-2). They can't join if they're on long-term immune-weakening drugs, have serious heart issues, are expected to live less than 2 months, or recently had cancer treatments.
What is being tested?
The study is testing the safety and initial effectiveness of a new drug called CC-99282 alone and combined with other lymphoma medications like Valemetostat, Tafasitamab, Obinutuzumab, and Rituximab in those whose lymphoma has relapsed or isn’t responding to current treatments.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as allergies or infusion-related symptoms. There might also be fatigue, digestive problems like nausea or diarrhea, blood cell count changes leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Non-Hodgkin's Lymphoma has come back or didn't respond to treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems that affect my daily activities.
Select...
I am on long-term immunosuppressants or have significant GVHD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
DOR
Duration of response (DoR)
ORR
+7 moreSide effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061971%
White blood cell count decreased
65%
Neutrophil count decreased
59%
Anaemia
59%
Lymphocyte count decreased
53%
Platelet count decreased
41%
Cytokine release syndrome
29%
Neutropenia
29%
Decreased appetite
18%
Diarrhoea
18%
Vomiting
18%
Muscular weakness
18%
Dizziness
18%
Neurotoxicity
18%
Insomnia
18%
Pleural effusion
18%
Hypertension
12%
Pyrexia
12%
Hypoxia
12%
Febrile neutropenia
12%
Thrombocytopenia
12%
Tachycardia
12%
Conjunctival haemorrhage
12%
Fatigue
12%
Pain
12%
Contusion
12%
Hyperuricaemia
12%
Hypokalaemia
12%
Hypomagnesaemia
12%
Tremor
12%
Dyspnoea
12%
Pruritus
6%
Appetite disorder
6%
Extrasystoles
6%
Hypercalcaemia
6%
Atrial fibrillation
6%
Blood creatinine increased
6%
Enteritis
6%
COVID-19
6%
Pneumonia
6%
Agraphia
6%
Large intestine perforation
6%
Hypofibrinogenaemia
6%
Supraventricular extrasystoles
6%
Ventricular tachycardia
6%
Periorbital oedema
6%
Visual impairment
6%
Abdominal distension
6%
Abdominal pain
6%
Anal incontinence
6%
Constipation
6%
Dry mouth
6%
Gastrointestinal disorder
6%
Oedema
6%
Oedema peripheral
6%
Physical deconditioning
6%
Jaundice
6%
Ocular icterus
6%
Conjunctivitis
6%
Cytomegalovirus infection reactivation
6%
Urinary tract infection
6%
Fall
6%
Alanine aminotransferase increased
6%
Blood bilirubin increased
6%
Dehydration
6%
Hypocalcaemia
6%
Hypophosphataemia
6%
Arthralgia
6%
Musculoskeletal chest pain
6%
Amnesia
6%
Peroneal nerve palsy
6%
Anxiety
6%
Confusional state
6%
Urinary retention
6%
Cough
6%
Oropharyngeal pain
6%
Night sweats
6%
Seborrhoeic dermatitis
6%
Deep vein thrombosis
6%
Haematoma
6%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Dose ExpansionExperimental Treatment5 Interventions
Group II: Part A: Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-99282
2020
Completed Phase 2
~80
Tafasitamab
2016
Completed Phase 3
~630
Obinutuzumab
2014
Completed Phase 3
~3470
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,002 Total Patients Enrolled
Poliana Patah, MD, PhDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
16 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,568 Previous Clinical Trials
3,383,926 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart problems that affect my daily activities.There are other requirements that you must meet or avoid to participate in the study.I am on long-term immunosuppressants or have significant GVHD.My Non-Hodgkin's Lymphoma has come back or didn't respond to treatment.I can take care of myself and am up and about more than half of my waking hours.Your expected lifespan is two months or less.I haven't taken any cancer drugs for at least 4 weeks or 5 half-lives, whichever is shorter, before starting CC-99282.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Dose Expansion
- Group 2: Part A: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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