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Monoclonal Antibodies

Obinutuzumab-Based Therapy for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Paul M Barr

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

Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible

Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine

Must not have

Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide

Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy to treat patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for adults with grade I-IIIa follicular lymphoma that has relapsed or is refractory. Eligible participants must have had only one prior chemotherapy regimen, be at least 18 years old, and have adequate organ function. They should not have CNS involvement by lymphoma or previous treatment with PI3K inhibitors or lenalidomide.

What is being tested?

The study tests obinutuzumab alone or combined with umbralisib, lenalidomide, or other chemotherapies to see which works best for treating relapsed/refractory follicular lymphoma. It explores how these treatments affect the immune system's ability to fight cancer and stop tumor growth.

What are the potential side effects?

Potential side effects include reactions related to the immune system's activation (like flu-like symptoms), effects from cell death (nausea, fatigue), possible increased risk of infections due to immune suppression, and specific drug-related risks like liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received anti-CD20 antibody therapy before CHOP or bendamustine treatment.

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I've had one round of chemotherapy with CHOP or bendamustine.

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I have managed hepatitis B or C, or HIV with no liver damage.

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I had a full medical check-up in the last 28 days.

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I have grade I, II, or IIIa follicular lymphoma with FDG-avid disease, and no large cell lymphoma involvement.

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My cancer returned or didn't fully respond within 2 years after my last CHOP or bendamustine treatment, without any other chemotherapy in between.

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My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.

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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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I am willing and able to take blood clot prevention medication if needed.

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I am 18 years old or older.

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My heart's pumping ability is confirmed to be good by a recent heart scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with PI3K inhibitors or lenalidomide.

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My lymphoma has not spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Active lymphoma and circulating tumor DNA in plasma

Duration of response (CR, partial response [PR])

Incidence of adverse events

+5 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574

44%

Neutropenia

35%

Thrombocytopenia

35%

Diarrhea

29%

Cough

24%

Arthralgia

23%

Infusion related reaction

19%

Fatigue

19%

Back pain

19%

Hypertension

17%

Anaemia

17%

Constipation

17%

Pyrexia

16%

Upper respiratory tract infection

15%

Rash maculo-papular

14%

Muscle spasms

14%

Atrial fibrillation

13%

Hyperuricaemia

13%

Nausea

13%

Nasopharyngitis

12%

Insomnia

12%

Urinary tract infection

12%

Oedema peripheral

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Dyspnoea

11%

Vomiting

11%

Pain in extremity

11%

Dizziness

10%

Cataract

10%

Decreased appetite

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Bronchopulmonary aspergillosis

Gastritis

Ischaemic stroke

Compartment syndrome

Inclusion body myositis

Colorectal cancer

Invasive ductal breast carcinoma

Uterine prolapse

Bronchitis chronic

Respiratory failure

Peripheral ischaemia

Haemoptysis

Oesophageal rupture

Pleural effusion

Colorectal cancer metastatic

Concussion

Cardiac failure congestive

Arthritis

Malignant melanoma

Non-small cell lung cancer

Bacterial sepsis

Myelodysplastic syndrome

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (obinutuzumab, lenalidomide)Experimental Treatment8 Interventions

Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Group II: Arm I (obinutuzumab, umbralisib)Experimental Treatment8 Interventions

CLOSED TO ACCRUAL: Patients receive obinutuzumab IV on day 1 and umbralisib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Group III: Arm III (obinutuzumab, combination chemotherapy)Active Control12 Interventions

PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Computed Tomography

2017

Completed Phase 2

~2790