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Monoclonal Antibodies
Brentuximab + Crizotinib Chemotherapy for Lymphoma
Phase 2
Waitlist Available
Led By Eric J Lowe
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
Adequate Liver Function Defined As: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
Adequate Cardiac Function Defined As: Shortening fraction of >= 27% by echocardiogram, or Ejection fraction of >= 50% by radionuclide angiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to progressive disease, relapse, or death, assessed up to 2 years
Awards & highlights
Study Summary
This trial is studying brentuximab vedotin and crizotinib in combination with chemotherapy to see if they are more effective than crizotinib and chemotherapy alone in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma.
Who is the study for?
This trial is for patients newly diagnosed with stage II-IV anaplastic large cell lymphoma (ALCL) that's CD30 and ALK positive. They should have a life expectancy of at least 8 weeks, normal liver function, good heart health, and no severe lung issues unless caused by the lymphoma. Pregnant women, those who've had prior chemotherapy for any cancer or immunodeficiency conditions are excluded.Check my eligibility
What is being tested?
The study compares brentuximab vedotin (a monoclonal antibody linked to a toxin) with crizotinib (an enzyme inhibitor), both combined with standard chemotherapy. The goal is to determine which combination is more effective in treating ALCL.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking body tissues, infusion-related symptoms like fever or chills, fatigue, nausea or vomiting from chemotherapy drugs, blood disorders such as low counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well, with normal bilirubin levels.
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My heart is strong, with a good pumping efficiency.
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My cancer is ALK positive.
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My cancer is at stage II, III, or IV.
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My liver enzyme (ALT) levels are within the normal range for my age.
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My disease is CD30 positive.
Select...
I have been newly diagnosed with ALCL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to progressive disease, relapse, or death, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to progressive disease, relapse, or death, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event Free Survival (EFS)
Occurrence of Grade 3+ Non-hematologic Adverse Events
Secondary outcome measures
Prognostic Significance of Minimal Residual Disease
Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Anaphylactic reaction
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm CZ (crizotinib, combination chemotherapy)Experimental Treatment8 Interventions
COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.
COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib PO BID as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
Group II: Arm BV (brentuximab vedotin, combination chemotherapy)Experimental Treatment8 Interventions
COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.
COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Etoposide
2010
Completed Phase 3
~2440
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Ifosfamide
2010
Completed Phase 4
~2980
Brentuximab Vedotin
2015
Completed Phase 4
~1070
Crizotinib
2014
Completed Phase 3
~2370
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,226 Total Patients Enrolled
Eric J LowePrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh more than 10 kg.My liver is functioning well, with normal bilirubin levels.My heart is strong, with a good pumping efficiency.I haven't had steroids or radiation unless it was for an urgent issue with my chest mass.My cancer has spread beyond just my skin.My cancer is not at stage I.I've had spinal chemotherapy for ALCL, but tests show no ALCL in my spinal fluid now.I do not have Down syndrome.My cancer is ALK positive.My lab results are off due to my lymphoma, but I can adjust my treatment dose.I can breathe normally without feeling short of breath and my oxygen level is above 92%.I haven't taken strong CYP3A4 inducer drugs in the last 12 days.I haven't taken strong CYP3A4 inhibitor drugs or grapefruit juice in the last week.I am not pregnant and if capable, have had a pregnancy test.I do not have a pre-existing immunodeficiency or have received an organ transplant.I am not taking medications like pimozide or triazolam regularly.My cancer is at stage II, III, or IV.I have not had chemotherapy for my current ALCL or any past cancer.My liver enzyme (ALT) levels are within the normal range for my age.My disease is CD30 positive.I have been newly diagnosed with ALCL.I do not have a brain or spinal cord disease.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm BV (brentuximab vedotin, combination chemotherapy)
- Group 2: Arm CZ (crizotinib, combination chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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