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Anti-metabolites
CC-486 + Lenalidomide + Obinutuzumab for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Joseph M Tuscano
Research Sponsored by Joseph Tuscano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (Subjects intolerant to acetylsalicylic acid [ASA] may use low molecular weight heparin)
Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, CC-486, to see if it is effective in treating patients with B-cell lymphoma that has come back or has not responded to treatment. The new drug will be tested in combination with lenalidomide and obinutuzumab.
Who is the study for?
This trial is for patients with CD20 positive B-cell lymphoma that's returned or hasn't responded to treatment. Participants must have had prior treatments, be able to consent, follow the study schedule, and swallow pills. They should not have other serious medical conditions or be on conflicting medications.Check my eligibility
What is being tested?
The trial tests CC-486 combined with lenalidomide and obinutuzumab for recurrent/refractory B-cell lymphoma. It explores how well this combination works and its safety profile in improving patient outcomes while minimizing side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's alteration, blood vessel development interference affecting tumor growth, direct cancer cell destruction, and general chemotherapy-related issues like nausea or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take daily aspirin or a substitute if I'm allergic.
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I am not taking HIV drugs that have similar side effects to the study drugs.
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I can swallow pills.
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I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.
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I am mostly active and can carry out daily activities.
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I have been treated for a type of lymphoma that tests positive for CD20.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Complete response rate
Duration of response
Event-free survival
+6 moreSide effects data
From 2023 Phase 3 trial • 216 Patients • NCT0156669576%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
47%
Constipation
28%
Pyrexia
27%
Thrombocytopenia
27%
Febrile neutropenia
27%
Oedema peripheral
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
21%
Fatigue
20%
Petechiae
18%
Anaemia
15%
Cough
14%
Contusion
13%
Abdominal pain
12%
Dyspnoea
12%
Back pain
11%
Urinary tract infection
11%
Hypokalaemia
9%
Weight decreased
9%
Leukopenia
9%
Insomnia
9%
Pneumonia
9%
Mouth haemorrhage
9%
Hypomagnesaemia
9%
Haematoma
8%
Anxiety
8%
Alanine aminotransferase increased
8%
Arthralgia
7%
Sepsis
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Pain in extremity
6%
Depression
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Iron overload
6%
Ecchymosis
6%
Hypotension
5%
Neutropenic sepsis
4%
Fall
3%
Lung infection
3%
General physical health deterioration
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Cardiac failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Gastroenteritis
1%
Corona virus infection
1%
Prerenal failure
1%
Escherichia sepsis
1%
Myocardial infarction
1%
Abdominal pain upper
1%
Gastritis
1%
Epididymitis
1%
Febrile infection
1%
Pancytopenia
1%
Renal colic
1%
Chronic kidney disease
1%
Lethargy
1%
Groin abscess
1%
Lower respiratory tract infection
1%
Device related infection
1%
Influenza
1%
Klebsiella infection
1%
Haemolytic anaemia
1%
Haemorrhagic anaemia
1%
Acute myocardial infarction
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
1%
Rectal haemorrhage
1%
Gait disturbance
1%
Hypothermia
1%
Abscess limb
1%
Arteriovenous fistula site infection
1%
Klebsiella sepsis
1%
Meningitis
1%
Meningitis bacterial
1%
Myringitis
1%
Pneumonia fungal
1%
Pneumonia pneumococcal
1%
Pseudomonal sepsis
1%
Pulmonary mycosis
1%
Respiratory tract infection
1%
Skin infection
1%
Staphylococcal infection
1%
Urinary tract infection bacterial
1%
Viral sepsis
1%
Periorbital haematoma
1%
Febrile nonhaemolytic transfusion reaction
1%
Head injury
1%
Hip fracture
1%
Subdural haemorrhage
1%
Upper limb fracture
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Diabetic metabolic decompensation
1%
Hyperkalaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Colon adenoma
1%
Mantle cell lymphoma recurrent
1%
Spinal cord neoplasm
1%
Central nervous system lesion
1%
Transient ischaemic attack
1%
Epilepsy
1%
Generalised tonic-clonic seizure
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pleurisy
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Hypersensitivity vasculitis
1%
Rash
1%
Rash generalised
1%
Shock haemorrhagic
1%
Cardiogenic shock
1%
Intra-abdominal haemorrhage
1%
Status epilepticus
1%
Syncope
1%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine Plus Best Supportive Care
Placebo Plus Best Supportive Care
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide, oral azacitidine, obinutuzumab)Experimental Treatment3 Interventions
Patients receive azacitidine PO QD on days 1-21, obinutuzumab IV over on days 8, 15, 22, and 29, and lenalidomide PO QD on days 8-28 of cycle 1. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Patients then receive azacitidine PO QD on days 1-21, obinutuzumab IV over on day 1, and lenalidomide PO QD on days 1-21. Cycles repeats every 28 days in the absence of disease progression, unacceptable toxicity, or until stem cell transplant. Patients who achieve SD, PR, or CR do not proceed to stem cell transplant may continue treatment for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Obinutuzumab
2015
Completed Phase 3
~3250
Oral Azacitidine
2013
Completed Phase 3
~480
Find a Location
Who is running the clinical trial?
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
174 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,145 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,963 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take daily aspirin or a substitute if I'm allergic.I am not taking HIV drugs that have similar side effects to the study drugs.I can swallow pills.People with HIV may be able to participate if they meet certain conditions.My lymphoma has spread to my brain or spinal cord.I am not using any other cancer treatments.I have been cancer-free for 3 years, except for certain skin cancers or early-stage cervical or breast cancer.I have hepatitis B or C but am on treatment with no liver damage.I have been treated for an autoimmune disease in the last 2 years.I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.I agree to follow the pregnancy testing schedule as required.You are expected to live for at least 3 more months.Your total bilirubin level is not more than 2 times the normal limit for the institution where the study is being conducted.I do not have any untreated severe infections.I haven't used any experimental drugs or therapies in the last 28 days.I am mostly active and can carry out daily activities.I have previously used obinutuzumab or CC-486.I have been treated for a type of lymphoma that tests positive for CD20.You are allergic to lenalidomide, thalidomide, obinutuzumab, or mannitol.You have a high level of white blood cells in your body.You have enough infection-fighting white blood cells.Your platelet count is at least 50,000 per microliter.Your AST and ALT levels in your blood are not more than 2.5 times the normal limit set by the hospital.My kidney function, measured by creatinine levels or clearance, is within the required range.I haven't had serious heart problems like heart failure or a heart attack in the last 6 months.Your blood does not clot normally.I don't have any bowel or stomach conditions that could affect how a study drug works or cause more side effects.You have at least one visible and measurable abnormality according to specific guidelines for lymphoma.I had a peeling rash from thalidomide or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lenalidomide, oral azacitidine, obinutuzumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the clinical applications of Oral Azacitidine?
"Oral Azacitidine is approved to treat anemia, refractory anemia, and chronic lymphocytic leukemia."
Answered by AI
What other investigations have been performed to assess Oral Azacitidine's efficacy?
"Currently, 529 active trials are investigating the use of Oral Azacitidine in medicine. Of those studies, 105 have advanced to phase 3 and a total of 23416 locations across the world are running these clinical trials. Chicago, Illinois is host to many such endeavors."
Answered by AI
How many participants are being incorporated into this clinical trial?
"Confirmed. According to information found on clinicaltrials.gov, this experiment began recruiting participants on October 23rd 2020 and is still actively seeking them out as of December 17th 2021. 24 volunteers are required from 1 medical site."
Answered by AI
Is there still the opportunity for patients to participate in this research?
"Affirmative. According to the information published on clinicaltrials.gov, this clinical trial is actively enrolling participants; it was initially posted on October 23rd 2020 and updated most recently on December 17th 2021. The research requires 24 volunteers across a single location."
Answered by AI
Has Oral Azacitidine been given the green light by the FDA?
"There is minimal clinical evidence in support of the safety and efficacy for Oral Azacitidine, therefore it received a score of 1."
Answered by AI
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