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Monoclonal Antibodies
ADCT-602 for B-Cell ALL
Phase 1 & 2
Recruiting
Led By Nitin Jain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Negative urine or serum beta-human chorionic gonadotropin (B-HCG) pregnancy test within 7 days prior to the cycle 1, day 1 visit, for women of child-bearing potential. Women of child bearing potential must agree to use an effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of ADCT-602. Men with female partners who are of child bearing potential must agree that they or their partners will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of ADCT-602
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new antibody to treat leukemia. The antibody may help stop the growth and spread of cancer cells.
Who is the study for?
This trial is for patients with B-cell acute lymphoblastic leukemia that has returned or isn't responding to treatment. Eligible participants must have a certain level of marrow blast count, normal liver and heart function, not be pregnant or breastfeeding, agree to use effective contraception, and cannot have had a recent transplant or other cancer treatments.Check my eligibility
What is being tested?
The trial is testing ADCT-602, a monoclonal antibody designed to stop tumor cells from growing and spreading in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. It's looking at the best dose and side effects.See study design
What are the potential side effects?
While specific side effects are not listed here, monoclonal antibodies like ADCT-602 can cause allergic reactions, fatigue, fever, chills, nausea/vomiting. Side effects depend on individual patient factors and the dosage received.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I am not pregnant and agree to use effective birth control during and after the treatment.
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I am a woman who could potentially become pregnant.
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My liver enzymes are within the normal range, or up to 5 times the normal limit if cancer has spread to my liver or bones.
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My cancer cells show a high level of CD22.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR)/ CR with incomplete marrow recovery (CR/CRi) rate (Phase II)
Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE)
Maximum tolerated dose (MTD) as determined by dose limiting toxicities (DLTs) (Phase I)
+1 moreSecondary outcome measures
ADCT-602 exposure on QT interval assessed by EKG
Measure the amount of ADCT-602 in the body at different time points.
Overall response rate (ORR)
+2 moreSide effects data
From 2015 Phase 3 trial • 793 Patients • NCT0126236513%
Headache
12%
Nausea
12%
Upper respiratory tract infection
10%
Urinary tract infection
9%
Sinusitis
8%
Diarrhoea
8%
Hypertension
8%
Arthralgia
8%
Nasopharyngitis
7%
Fatigue
7%
Back pain
6%
Migraine
5%
Cough
5%
Pain in extremity
5%
Rash
5%
Bronchitis
3%
Dizziness
2%
Systemic lupus erythematosus
1%
Sepsis
1%
Cellulitis
1%
Anaemia
1%
Lupus nephritis
1%
Nephrotic syndrome
1%
Pulmonary embolism
1%
Cholelithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Weekly Infusion)
Epratuzumab 1200 mg Every Other Week
Epratuzumab 600 mg Per Week
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADCT-602Experimental Treatment1 Intervention
Patients receive ADCT-602 by vein over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,252 Total Patients Enrolled
5 Trials studying B Acute Lymphoblastic Leukemia
204 Patients Enrolled for B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,456 Total Patients Enrolled
22 Trials studying B Acute Lymphoblastic Leukemia
19,903 Patients Enrolled for B Acute Lymphoblastic Leukemia
ADC Therapeutics S.A.Industry Sponsor
28 Previous Clinical Trials
2,168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I am experiencing complications from a transplant.I do not have any untreated or uncontrolled infections.I am unable to give consent for this study by myself.I do not have active leukemia in my brain or spinal cord.I haven't had major cancer treatments in the last 14 days or within their half-lives.I have a history of or currently have VOD.I do not have severe heart, lung, or diabetes issues.I am not pregnant and agree to use effective birth control during and after the treatment.I am a woman who could potentially become pregnant.My B-ALL has returned or didn't respond to treatment, and I've failed a tyrosine kinase inhibitor therapy.I had a stem cell transplant within the last 2 months.I have had cancer before, but it's either still being treated or was in remission less than 2 years ago, except for non-melanoma skin cancers or cancers that were only found in the place they started and have not spread.My kidney function is within the required range.My liver enzymes are within the normal range, or up to 5 times the normal limit if cancer has spread to my liver or bones.You have had a severe skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis in the past.My cancer has returned in a specific area outside of the bone marrow.I have Burkitt's leukemia/lymphoma.My cancer cells show a high level of CD22.
Research Study Groups:
This trial has the following groups:- Group 1: ADCT-602
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are a part of this clinical trial?
"The information available on clinicaltrials.gov suggests that this trial is still open to candidates. The listing for the trial was created on 8/24/2018 and edited most recently on 8/31/2022. There are 65 spots open across 2 locations."
Answered by AI
Can people with the disease still enroll in this research program?
"The data on clinicaltrials.gov does show that this trial is currently looking for patients. The listing was first posted on 8/24/2018 and was most recently updated on 8/31/2022. A total of 65 patients are needed for the study, which will be conducted at 2 different sites."
Answered by AI
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