Study on Daratumumab for Treating Chemotherapy-Resistant Minimal Residual Disease in T Cell Acute Lymphoblastic Leukemia (T-ALL)

Sponsor: Eastern Cooperative Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05289687

Provider View

This clinical trial is testing whether the drug daratumumab-hyaluronidase can effectively treat T-ALL in patients who still have minimal residual disease (MRD) after chemotherapy. The study aims to see if this treatment can improve survival rates and is well-tolerated after a stem cell transplant.

Patient Parameters

Program Overview

The study is exploring whether daratumumab-hyaluronidase can help eliminate minimal residual disease (MRD) in patients with T Cell Acute Lymphoblastic Leukemia (T-ALL) who have not fully responded to chemotherapy. Researchers are also looking at whether this treatment can improve survival rates and is safe to use after a stem cell transplant. The main goal is to see how well the treatment works after four weekly doses. Other goals include checking survival rates, side effects, and how well patients do after a stem cell transplant.

Description

This study is testing a drug called daratumumab-hyaluronidase to see if it can help patients with T Cell Acute Lymphoblastic Leukemia (T-ALL) who still have minimal residual disease (MRD) after chemotherapy. The main goal is to find out if the drug can completely eliminate MRD after four weekly doses. Researchers also want to see if the drug can improve survival rates and is safe to use after a stem cell transplant. They will monitor patients for side effects and check their MRD status at different points during the treatment. The study will also look at how well patients do if they receive chemotherapy along with daratumumab-hyaluronidase.

Eligibility Criteria

Inclusion Criteria

  • Must have T Cell Acute Lymphoblastic Leukemia (T-ALL) and be in complete remission or partial remission after at least two rounds of intensive chemotherapy.
  • Must have persistent or returning minimal residual disease (MRD) at a specific level.
  • Must have test results confirming MRD status.
  • May have had a previous stem cell transplant but cannot have ongoing Graft Versus Host Disease (GVHD) requiring immunosuppressive therapy.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Must agree to use effective contraception or abstain from sex during the study and for three months after the last treatment.
  • Must be able to understand and sign a consent form, or have a representative to do so.
  • Must have adequate organ and bone marrow function, as shown by specific lab tests.
  • HIV-positive patients must be on effective treatment with an undetectable viral load.
  • Patients with hepatitis B or C must have controlled or cured infections.
  • Patients with previous central nervous system (CNS) involvement must not have active CNS disease.
  • Patients with other cancers that do not interfere with the study are eligible.
  • Patients with heart disease must have a risk assessment and be in class 2B or better according to the New York Heart Association.

Exclusion Criteria

  • Must not be pregnant or breastfeeding due to potential risks to the baby.

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