Study on ADCT-602 for Treating Patients with Recurrent or Hard-to-Treat B-cell Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03698552

Provider View

This clinical trial is testing the safety and best dose of a new drug, ADCT-602, for patients with B-cell acute lymphoblastic leukemia that has returned or is not responding to treatment. The study aims to see if ADCT-602 can help stop the cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is exploring the effects of a new drug called ADCT-602 on patients with B-cell acute lymphoblastic leukemia (B-ALL) that has either come back after treatment or is not responding to current treatments. The trial is divided into two phases: Phase I focuses on finding the safest and most effective dose, while Phase II evaluates how well the drug works in treating the cancer. ADCT-602 is a type of monoclonal antibody that may help prevent cancer cells from growing and spreading.

Description

The main goals of this study are to determine the safest dose of ADCT-602 and to see how well it works in treating B-cell acute lymphoblastic leukemia (B-ALL) that has returned or is not responding to treatment. In Phase I, researchers will find the maximum dose that patients can tolerate. In Phase II, they will assess the effectiveness of the drug in achieving a complete response, even if the bone marrow has not fully recovered.

Secondary goals include evaluating how long the response lasts, overall survival rates, and how long patients remain free from disease progression. The study will also look at how the drug is processed in the body and its potential effects on heart rhythm.

The study involves a dose escalation phase followed by a Phase II study. Patients will receive ADCT-602 through an IV infusion over 30 minutes on the first day of each treatment cycle, which repeats every 21 days unless the disease progresses or side effects become unacceptable. If patients achieve a complete response, they will receive the drug every 28 days.

After completing the treatment, patients will have follow-up visits at 30 days and then every 12 weeks for up to a year to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have B-cell acute lymphoblastic leukemia (B-ALL) that has returned or is not responding to treatment. Patients with a specific genetic marker (Philadelphia chromosome) are eligible if previous treatments have failed.
  • Cancer cells must show a marker called CD22 in at least 20% of cells.
  • Have a certain level of cancer cells in the bone marrow.
  • Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have normal kidney function or a creatinine clearance above a certain level.
  • Have liver enzymes and bilirubin levels within specified limits.
  • Have a heart's left ventricle pumping ability of 45% or higher.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 16 weeks after the last dose. Men must also agree to use contraception.
  • Have a white blood cell count below a specified level before starting treatment.

Exclusion Criteria

  • Have active leukemia in the central nervous system (CNS) or symptoms affecting the brain or nerves.
  • Have Burkitt's leukemia/lymphoma.
  • Have active or severe graft-versus-host disease (GVHD).
  • Have had a stem cell transplant within 60 days before starting the study.
  • Have a known allergy to CD22 antibodies.
  • Test positive for HIV, hepatitis B, or hepatitis C.
  • Have a history of severe skin reactions like Stevens-Johnson syndrome.
  • Be pregnant or breastfeeding.
  • Have uncontrolled high blood pressure, heart problems, or other serious medical conditions.
  • Have used other experimental medications recently.
  • Have had major surgery or certain cancer treatments recently.
  • Have an uncontrolled infection.
  • Have another untreated or active cancer.
  • Have any other significant medical condition that would make participation unsafe.
  • Be unable to provide informed consent.

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