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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

O-ICE Trial Summary

This trial is testing if it's safe to give obinutuzumab to children and young adults with relapsed CD20+ B-cell NHL, either alone or with ICE chemotherapy. They will also look at the response rate to this treatment.

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.Check my eligibility
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.See study design
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.

O-ICE Trial Eligibility Criteria

Inclusion Criteria

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

O-ICE Trial Timeline

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

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 • 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
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
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%
Acute myocardial infarction
1%
Haemoptysis
1%
Bronchopulmonary aspergillosis
1%
Arthritis
1%
Colorectal cancer
1%
Myelodysplastic syndrome
1%
Ischaemic stroke
1%
Uterine prolapse
1%
Concussion
1%
Compartment syndrome
1%
Non-small cell lung cancer
1%
Leukopenia
1%
Bronchitis chronic
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Malignant melanoma
1%
Respiratory failure
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
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

O-ICE 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
Ifosfamide
FDA approved
Etoposide
FDA approved
Obinutuzumab
FDA approved
Carboplatin
FDA approved

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,036 Total Patients Enrolled
Roswell Park Cancer InstituteOTHER
402 Previous Clinical Trials
30,782 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

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02393157 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: CNS Positive, Central Nervous System (CNS) Negative
Non-Hodgkin's Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02393157 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02393157 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any mature individuals being considered for this medical experiment?

"Eligible participants must be at least 3 years of age and no older than 31."

Answered by AI

Are there any precedential examples of Obinutuzumab being used in a clinical research setting?

"Presently, 1160 active clinical trials for Obinutuzumab are being conducted. The preponderance of these investigations fall under the Phase 3 classification, and they take place in 63891 different medical centres throughout Shanghai."

Answered by AI

To whom is this research opportunity available?

"To be considered, applicants must possess a diagnosis of Burkitt Lymphoma and to have attained between 3 and 31 years old. The trial is seeking 25 participants in total."

Answered by AI

What is the scale of individuals enrolled in this clinical experiment?

"Affirmative. According to the records available on clinicaltrials.gov, this trial is actively inviting patients for participation; it was first posted in February of 2015 and its most recent update occurred on September 27th 2022. There are 25 spots open across 1 medical centre."

Answered by AI

In what ailments is Obinutuzumab commonly recommended?

"Obinutuzumab is commonly prescribed for the primary treatment of cancer, as well as prostate carcinoma, SCLC (small cell lung cancer), and advanced testicular malignancy."

Answered by AI

Are there any vacancies available for potential participants in this research?

"Absolutely, the posted information on clinicaltrials.gov shows that this study is actively enrolling participants. It was initially published in February 2015 and recently updated at the end of September 2022. 25 patients are required for successful completion from 1 dedicated medical centre."

Answered by AI

Has the U.S. Food and Drug Administration granted approval for Obinutuzumab?

"Obinutuzumab's safety is judged to be a 2, as this clinical trial has only provided evidence for the former and not yet the latter."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Mitchell Cairo 2015. "Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02393157.
All > Follicular Lymphoma
~2 spots leftby Dec 2024
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