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Alkylating agents
Oral Azacitidine + R-miniCHOP for Diffuse Large B-Cell Lymphoma
Huntington Beach, CA
Phase 2 & 3
Recruiting
Led By Elizabeth A Brem
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with Grade IIIB follicular lymphoma (FL) or high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements are also eligible
Participants with DLBCL transformed from follicular lymphoma (FL) or marginal zone lymphoma (MZL, including mucosa-associated lymphoid tissue [MALT] lymphomas), lymphoplasmacytic lymphoma (LPL), or nodular lymphocyte-predominant Hodgkin Lymphoma (NLPHL) are eligible
Must not have
Participants must not have any other known uncontrolled intercurrent illness
Participants must not have active inflammatory bowel disease, celiac disease, prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial compares side effects & activity of azacitidine & R-miniCHOP (monoclonal antibody, prednisone, 3 chemo drugs) in 75+ newly-diagnosed DLBCL patients. Combining azacitidine & R-miniCHOP may shrink the cancer or extend time w/o symptoms/survival compared to R-miniCHOP alone.
See full description
Who is the study for?
This trial is for people aged 75 or older with newly diagnosed diffuse large B cell lymphoma. They must have certain types of this cancer, adequate organ function, and no history of specific treatments for DLBCL. HIV-positive patients can join if their viral load is undetectable, but those with CNS involvement or certain gastrointestinal issues cannot participate.Check my eligibility
What is being tested?
The study compares oral azacitidine plus R-miniCHOP (a combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) against R-miniCHOP alone to see which is better at shrinking the cancer or extending symptom-free survival in elderly patients.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to rituximab, inflammation from prednisone use; and typical chemotherapy-related issues like nausea, fatigue, hair loss from doxorubicin; nerve damage from vincristine; and potential blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is advanced (Grade IIIB) or high-grade with specific genetic changes.
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My DLBCL cancer developed from another type of lymphoma.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My kidneys work well enough, with a creatinine clearance of 30 ml/min or more.
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I agree to use contraception and not donate sperm during the trial.
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My lymphoma type is one of the specified eligible subtypes.
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My cancer did not develop from previous CLL.
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My liver, blood, and heart are functioning within normal ranges.
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I have been diagnosed with a specific type of lymphoma called DLBCL.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled illnesses besides my cancer.
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I do not have any major gut issues that could affect how a drug works in my body.
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I do not have any ongoing infections that aren't under control.
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I have received less than 250 mg/m^2 of doxorubicin.
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My cancer has not spread to my brain or spinal cord.
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I have not had severe nerve pain or tingling in the last month.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Excess toxicity as a result of adding oral azacitidine (CC-486) to reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-miniCHOP) (Safety run-in)
Overall survival (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary study objectives
Incidence of adverse events
Metabolic complete response (CR)
Other study objectives
Changes in function (Integrated Correlative Geriatric Assessments Substudy)
Frailty status (Integrated Correlative Geriatric Assessments Substudy)
Frailty status (fit/unfit vs frail) (Integrated Correlative Geriatric Assessments Substudy)
Side effects data
From 2023 Phase 3 trial • 216 Patients • NCT0156669576%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
48%
Constipation
30%
Pyrexia
28%
Thrombocytopenia
28%
Oedema peripheral
27%
Febrile neutropenia
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
23%
Fatigue
21%
Anaemia
20%
Petechiae
15%
Abdominal pain
15%
Cough
15%
Contusion
14%
Back pain
13%
Dyspnoea
12%
Pneumonia
11%
Urinary tract infection
11%
Hypokalaemia
10%
Weight decreased
10%
Insomnia
10%
Hypomagnesaemia
10%
Arthralgia
10%
Haematoma
9%
Leukopenia
9%
Mouth haemorrhage
9%
Alanine aminotransferase increased
8%
Anxiety
7%
Atrial fibrillation
7%
Sepsis
7%
Depression
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Iron overload
7%
Pain in extremity
6%
Fall
6%
Cardiac failure
6%
Hyperkalaemia
6%
Syncope
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Ecchymosis
6%
Pruritus
6%
Hypotension
5%
Neutropenic sepsis
5%
Hypertension
4%
Haematuria
4%
Haemorrhoids
3%
Lung infection
3%
General physical health deterioration
3%
Rectal haemorrhage
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Pneumonia fungal
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Metastases to liver
1%
Lip squamous cell carcinoma
1%
Cerebral ischaemia
1%
Diffuse large B-cell lymphoma
1%
Abdominal pain upper
1%
Cutaneous vasculitis
1%
Oesophageal varices haemorrhage
1%
Small intestine carcinoma
1%
Epididymitis
1%
Gastroenteritis
1%
Haemophagocytic lymphohistiocytosis
1%
Prerenal failure
1%
Febrile infection
1%
Corona virus infection
1%
Pancytopenia
1%
Colorectal adenoma
1%
Gastritis
1%
Blood loss anaemia
1%
Atrioventricular block complete
1%
Pneumonia aspiration
1%
Blood urea increased
1%
Pollakiuria
1%
Coronavirus infection
1%
COVID-19 pneumonia
1%
Escherichia sepsis
1%
Myocardial infarction
1%
Renal colic
1%
Adenocarcinoma of colon
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%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
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 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%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Basal cell carcinoma
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%
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%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine and Best Supportive Care
Placebo Plus Best Supportive Care
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
Active Control
Group I: Arm I (oral azacitidine, R-miniCHOP)Experimental Treatment8 Interventions
Patients receive CC-486 PO for 7 days prior to cycle 1. Patients then receive CC-486 PO on days 8-21. Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Group II: Arm II (R-miniCHOP)Active Control7 Interventions
Patients receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~950
Rituximab
1999
Completed Phase 4
~2990
Biospecimen Collection
2004
Completed Phase 3
~1810
Vincristine Sulfate
2004
Completed Phase 3
~10650
Prednisone
2014
Completed Phase 4
~2500
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Cyclophosphamide
2010
Completed Phase 4
~2280
Find a Location
Closest Location:City of Hope Seacliff· Huntington Beach, CA
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
14,056 Previous Clinical Trials
41,149,049 Total Patients Enrolled
Elizabeth A BremPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma is advanced (Grade IIIB) or high-grade with specific genetic changes.I do not have any uncontrolled illnesses besides my cancer.You need to be tested for chronic hepatitis B virus within 28 days before joining the study.I can take care of myself and am up and about more than 50% of my waking hours.My kidneys work well enough, with a creatinine clearance of 30 ml/min or more.I agree to use contraception and not donate sperm during the trial.You have not had allergic reactions to certain medications.I do not have any major gut issues that could affect how a drug works in my body.My DLBCL cancer developed from another type of lymphoma.I've had a scan to check my cancer stage within the last 28 days, preferably a PET-CT.I am using effective birth control and can become pregnant.My lymphoma type is one of the specified eligible subtypes.My cancer did not develop from previous CLL.I haven't had chemotherapy or rituximab for my newly diagnosed DLBCL, except possibly a small pre-phase treatment.I do not have any ongoing infections that aren't under control.I have received less than 250 mg/m^2 of doxorubicin.I have HIV but am on effective treatment and my recent tests show no detectable virus.I have not had heart disease in the last 6 months.My cancer has not spread to my brain or spinal cord.My liver, blood, and heart are functioning within normal ranges.I have not had severe nerve pain or tingling in the last month.I have been diagnosed with a specific type of lymphoma called DLBCL.My hepatitis C is undetectable as of the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (oral azacitidine, R-miniCHOP)
- Group 2: Arm II (R-miniCHOP)
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.