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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

Must not have

Active graft-versus-host disease (GVHD) or severe/extensive chronic GVHD

Uncontrolled active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing complications from a transplant.

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I do not have any untreated or uncontrolled infections.

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I am unable to give consent for this study by myself.

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I have a history of or currently have VOD.

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I do not have severe heart, lung, or diabetes issues.

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My cancer has returned in a specific area outside of the bone marrow.

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I have Burkitt's leukemia/lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Measure the amount of ADCT-602 in the body at different time points.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 12Eligibility criteria met