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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 below
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My liver is functioning well, with normal bilirubin levels.
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My heart is strong, with a good pumping efficiency.
Select...
My cancer is ALK positive.
Select...
My cancer is at stage II, III, or IV.
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My lab results are off due to my lymphoma, but I can adjust my treatment dose.
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I can breathe normally without feeling short of breath and my oxygen level is above 92%.
Select...
My liver enzyme (ALT) levels are within the normal range for my age.
Select...
My disease is CD30 positive.
Select...
I have been newly diagnosed with ALCL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to progressive disease, relapse, or death, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to progressive disease, relapse, or death, assessed up to 2 years for reporting.

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 • NCT01990534
18%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Neuropathy peripheral
10%
Neutropenia
10%
Diarrhoea
8%
Polyneuropathy
8%
Anaemia
8%
Nausea
8%
Upper respiratory tract infection
7%
Vomiting
7%
Decreased appetite
7%
Arthralgia
5%
Hypomagnesaemia
5%
Paraesthesia
5%
Asthenia
5%
Hypokalaemia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Back pain
3%
Bone pain
3%
Headache
3%
Depression
3%
Oral herpes
3%
Thrombocytopenia
3%
Tachycardia
3%
Abdominal pain
3%
Constipation
3%
Subcutaneous abscess
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Pruritus
3%
Rash
2%
Upper respiratory tract inflammation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Anaphylactic reaction
2%
Lymphoedema
2%
Renal tubular disorder
2%
Genital haemorrhage
2%
Catheter site inflammation
2%
Chest pain
2%
Chills
2%
Malaise
2%
Oedema
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Blood lactate dehydrogenase increased
2%
Blood thyroid stimulating hormone increased
2%
Gamma-glutamyltransferase increased
2%
Lymphocyte count decreased
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Hyperuricaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Facial nerve disorder
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Extravasation
2%
Fatigue
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Dengue fever
2%
Influenza
2%
Klebsiella infection
2%
Toothache
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Ligament sprain
2%
Procedural pain
2%
Blood alkaline phosphatase increased
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
~3780
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Etoposide
2010
Completed Phase 3
~2440
Ifosfamide
2010
Completed Phase 4
~2980
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Brentuximab Vedotin
2015
Completed Phase 4
~1100
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
13,603 Previous Clinical Trials
40,913,138 Total Patients Enrolled
Eric J LowePrincipal InvestigatorChildren's Oncology Group

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01979536 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01979536 — Phase 2
Anaplastic Large Cell Lymphoma Research Study Groups: Arm BV (brentuximab vedotin, combination chemotherapy), Arm CZ (crizotinib, combination chemotherapy)
Anaplastic Large Cell Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT01979536 — Phase 2

Frequently Asked Questions

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

What are the main indications for Brentuximab Vedotin?

"Brentuximab Vedotin is used to treat primary cutaneous anaplastic large cell lymphoma, kaposi's sarcoma aids related, merkel cell cancer, and other conditions."

Answered by AI

Could you walk me through the other research studies that have included Brentuximab Vedotin?

"Currently, there are a total of 1969 clinical trials studying the efficacy of Brentuximab Vedotin. Out of those, 420 are in Phase 3. The majority of these studies originate from Mishawaka, Indiana; however, there are 67819 research sites running investigations on this medication."

Answered by AI

Are other healthcare facilities also conducting this experiment within the state's borders?

"Currently, this trial has 100 patients that have signed up, which comes from locations such as Laura and Isaac Perlmutter Cancer Center at NYU Langone in New york, Roswell Park Cancer Institute in Buffalo, Golisano Children's Hospital of Southwest Florida in Fort Myers."

Answered by AI

Are patients currently being recruited for this research project?

"Data from clinicaltrials.gov indicates that this trial is not currently looking for patients to enroll. Although, it is worth noting that there are 3765 other trials similar to this one which ARE recruiting patients. This particular study was posted on November 8th, 2013 and last updated September 24th, 2022."

Answered by AI

Has Brentuximab Vedotin passed clinical trials in the United States?

"While Phase 2 trials don't usually have data supporting efficacy, Brentuximab Vedotin's safety has been supported by some clinical data and received a score of 2."

Answered by AI

How many test subjects are needed for this experiment?

"This study is not enrolling new patients at this time, as the last update was on September 24th, 2022. However, there are other ongoing clinical trials that may be of interest. There are currently 1796 active studies recruiting participants with lymphoma and 1969 for Brentuximab Vedotin."

Answered by AI

Has a similar trial been conducted before?

"Brentuximab Vedotin has undergone 3337 clinical trials since 1997. These studies are still ongoing in 87 different countries and across 3320 cities. The earliest trial, sponsored by Alfacell, reached Phase 3 approval with 300 patients enrolled."

Answered by AI
~12 spots leftby Mar 2025