What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those involving monoclonal antibodies like obinutuzumab, often result in side effects such as infusion-related reactions (fever, chills, rash), neutropenia (low white blood cell count), and increased risk of infections. When combined with chemotherapy agents like ifosfamide, carboplatin, and etoposide (ICE), additional side effects can include nausea, vomiting, hair loss, and fatigue. Severe side effects may include febrile neutropenia, tumor lysis syndrome, and organ toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that target CD20, similar to obinutuzumab. Rituximab was one of the first anti-CD20 monoclonal antibodies approved and has been widely used in combination with chemotherapy regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). Ofatumumab and obinutuzumab are other anti-CD20 monoclonal antibodies that have received FDA approval. These drugs are often used in combination with other chemotherapeutic agents or as part of targeted therapy regimens to improve treatment outcomes in patients with NHL.

What other types of research exist?

Promising novel alternatives to Obinutuzumab for Non-Hodgkin's Lymphoma patients include: 1) Elotuzumab, which has shown efficacy in combination with lenalidomide and dexamethasone in multiple myeloma and may have potential in NHL. 2) Daratumumab, a monoclonal antibody targeting CD38, which has demonstrated effectiveness in multiple myeloma and is being explored in other hematologic malignancies. 3) CAR T-cell therapies, such as those targeting CD19, which have shown significant promise in relapsed or refractory B-cell malignancies. 4) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 and have been effective in B-cell precursor acute lymphoblastic leukemia and are being investigated in NHL.

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Alkylating agents

Obinutuzumab + ICE for Non-Hodgkin's Lymphoma (O-ICE Trial)

Phase 2

Recruiting

Led By Matthew Barth, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have received myelosuppressive chemotherapy within 2 weeks of entry onto this study

Patients in first relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma including Diffuse Large B-Cell Lymphoma, Burkitt Lymphoma, High Grade B-cell Lymphoma: Not Otherwise Specified (NOS), Primary mediastinal B-cell lymphoma (PMBL), CD20+ B-lymphoblastic lymphoma, Follicular lymphoma, Grade III

Must not have

Patients with newly diagnosed, previously untreated B-NHL

Uncontrolled hepatitis B and/or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing the safety and effectiveness of obinutuzumab, both by itself and in combination with other cancer drugs, in young patients whose B-cell Non-Hodgkin Lymphoma has returned. Obinutuzumab helps the immune system find and destroy cancer cells, while the other drugs directly kill the cancer cells. Obinutuzumab has shown promising results in various studies.

Who is the study for?

This trial is for children, adolescents, and young adults with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to initial treatment. Participants need good organ function and a performance status score (Karnofsky/Lansky) above 60%. They shouldn't have had recent chemotherapy, radiation therapy in specific time frames, prior obinutuzumab treatment, or uncontrolled hepatitis.

What is being tested?

The study tests the safety and response rate of obinutuzumab alone and combined with ICE chemotherapy (ifosfamide, carboplatin, etoposide) in treating relapsed CD20 positive B-cell Non-Hodgkin Lymphoma. It aims to find out how well this combination works for these patients.

What are the potential side effects?

Possible side effects include allergic reactions to monoclonal antibodies like obinutuzumab; effects from chemo such as nausea, hair loss, low blood cell counts leading to infection risk; fatigue; organ damage due to drug toxicity; and potential complications from weakened immune systems.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had chemotherapy that lowers my blood cell counts in the last 2 weeks.

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My cancer is a type of B-cell leukemia/lymphoma and is in its first relapse or did not respond to initial treatment.

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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

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

Select...

I have been newly diagnosed with B-cell Non-Hodgkin's Lymphoma and have not received any treatment.

Select...

I do not have uncontrolled hepatitis B or C.

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I have had a solid organ transplant.

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I had a stem cell transplant less than 60 days ago or have severe GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Response rate assessed following each treatment cycle for regression of tumor

Safety as assessed by adverse reactions and events

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

Oesophageal rupture

Colorectal cancer

Respiratory failure

Peripheral ischaemia

Compartment syndrome

Invasive ductal breast carcinoma

Malignant melanoma

Non-small cell lung cancer

Uterine prolapse

Bronchitis chronic

Myelodysplastic syndrome

Haemoptysis

Pleural effusion

Bronchopulmonary aspergillosis

Cardiac failure congestive

Gastritis

Concussion

Arthritis

Inclusion body myositis

Colorectal cancer metastatic

Ischaemic stroke

Bacterial sepsis

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Central Nervous System (CNS) NegativeExperimental Treatment5 Interventions

All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

Group II: CNS PositiveExperimental Treatment5 Interventions

All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

FDA approved

Ifosfamide

FDA approved

Carboplatin

FDA approved

Etoposide

FDA approved

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies like obinutuzumab, rituximab, and ofatumumab target the CD20 protein on the surface of B-cells, leading to their destruction through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Chemotherapy agents, such as bendamustine, work by damaging the DNA of rapidly dividing cells, causing cell death. Targeted therapies, like Bruton tyrosine kinase (BTK) inhibitors (ibrutinib, acalabrutinib), interfere with specific signaling pathways crucial for cancer cell survival and proliferation. These treatments are vital for NHL patients as they offer multiple mechanisms to attack cancer cells, potentially leading to better outcomes and prolonged survival.

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor

71 Previous Clinical Trials

6,129 Total Patients Enrolled

Roswell Park Cancer InstituteOTHER

412 Previous Clinical Trials

32,710 Total Patients Enrolled

Mitchell Cairo, MDStudy Chair - New York Medical College

Fort Washington Medical Center, Holy Cross Germantown Hospital, Holy Cross Hospital of Silver Spring, Inova Alexandria Hospital, Inova Fairfax Hospital, MedStar Southern Maryland, Said M Ali Mdpc, Washington Adventist Hospital

University Of Cairo (Medical School)

Aultman Hospital (Residency)

13 Previous Clinical Trials

311 Total Patients Enrolled