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Alkylating agents

Oral Azacitidine + R-miniCHOP for Diffuse Large B-Cell Lymphoma

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
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

Study 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.

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 below
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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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I've had a scan to check my cancer stage within the last 28 days, preferably a PET-CT.
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I am using effective birth control and can become pregnant.
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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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I have HIV but am on effective treatment and my recent tests show no detectable virus.
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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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My hepatitis C is undetectable as of the last month.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Incidence of adverse events
Metabolic complete response (CR)
Overall survival (Phase III)
Other outcome measures
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 • NCT01566695
76%
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%
Corona virus infection
1%
Febrile infection
1%
Escherichia sepsis
1%
Epididymitis
1%
Renal colic
1%
Gastroenteritis
1%
Prerenal failure
1%
Gastritis
1%
Abdominal pain upper
1%
Myocardial infarction
1%
Pancytopenia
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (oral azacitidine, R-miniCHOP)Experimental Treatment7 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.
Group II: Arm II (R-miniCHOP)Active Control6 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~480
Rituximab
1999
Completed Phase 4
~1880
Vincristine Sulfate
2005
Completed Phase 3
~10110
Prednisone
2014
Completed Phase 4
~2370
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,413 Total Patients Enrolled
Elizabeth A BremPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04799275 — Phase 2 & 3
Diffuse Large B-Cell Lymphoma Research Study Groups: Arm I (oral azacitidine, R-miniCHOP), Arm II (R-miniCHOP)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04799275 — Phase 2 & 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799275 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~110 spots leftby Mar 2025