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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
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 belowSelect...
I haven't had chemotherapy that lowers my blood cell counts in the last 2 weeks.
Select...
My cancer is a type of B-cell leukemia/lymphoma and is in its first relapse or did not respond to initial treatment.
Select...
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.
Select...
I have had a solid organ transplant.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0226457444%
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
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Headache
8%
Iron deficiency
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Adenocarcinoma of colon
3%
Acute coronary syndrome
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Concussion
1%
Oesophageal rupture
1%
Bacterial sepsis
1%
Bronchitis chronic
1%
Haemoptysis
1%
Respiratory failure
1%
Gastritis
1%
Myelodysplastic syndrome
1%
Peripheral ischaemia
1%
Colorectal cancer
1%
Bronchopulmonary aspergillosis
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Malignant melanoma
1%
Pleural effusion
1%
Leukopenia
1%
Acute myocardial infarction
1%
Cardiac failure congestive
1%
Arthritis
1%
Compartment syndrome
1%
Inclusion body myositis
1%
Non-small cell lung cancer
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB
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
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
70 Previous Clinical Trials
6,108 Total Patients Enrolled
Roswell Park Cancer InstituteOTHER
408 Previous Clinical Trials
32,393 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy that lowers my blood cell counts in the last 2 weeks.I have never been treated with obinutuzumab.I have been newly diagnosed with B-cell Non-Hodgkin's Lymphoma and have not received any treatment.My cancer is a type of B-cell leukemia/lymphoma and is in its first relapse or did not respond to initial treatment.My last radiation therapy was over 2 weeks ago for a small area, over 6 months ago if it was for my brain or spine, or involved more than half of my pelvis, and over 6 weeks ago for other significant bone marrow radiation.My organs are working well.I am mostly able to care for myself and carry out daily activities.I do not have uncontrolled hepatitis B or C.I started steroids not more than a week ago before beginning the treatment in this study.I have had a solid organ transplant.I had a stem cell transplant less than 60 days ago or have severe GVHD.
Research Study Groups:
This trial has the following groups:- Group 1: CNS Positive
- Group 2: Central Nervous System (CNS) Negative
Awards:
This trial has 3 awards, including:- 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.
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.
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