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NCT05289687Possibly a fitRecruiting

Daratumumab for hard-to-clear T-cell leukemia traces

T-cell Acute Lymphoblastic Leukemia

Part of Blood & lymphatic, Cancer, Immune system & allergy clinical trials.

This Phase 2 trial tests daratumumab (a targeted antibody medicine) in people with T-cell ALL whose leukemia is not fully gone at very low levels. The goal is to eliminate “minimal residual disease” (MRD) that can predict relapse, so treatment may be more effective after intensive chemotherapy.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
20 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have T-cell acute lymphoblastic leukemia (T-cell ALL) that is in remission after chemotherapy (first or later remission), or almost in remission (CRi).
  • Your leukemia trace level (MRD) is still present or has returned at a level of at least 1 in 10,000 (MRD ≥ 10^-4), confirmed by a central test using flow cytometry.
  • You’ve had at least two blocks of intensive chemotherapy before starting this study.
  • If you had a bone marrow transplant, you cannot have ongoing graft-versus-host disease (GVHD) that needs ongoing immune-suppressing medicines (small-dose prednisone up to 10 mg/day is allowed).
  • Your strength and organs must meet lab/health thresholds (including neutrophils ≥ 750, platelets ≥ 75,000; and liver/kidney/bilirubin within set limits).
  • If you could become pregnant or father a child, you must use reliable contraception (or not have sex) during the study and for 3 months after the last dose, and you must agree not to donate eggs/sperm during that time.

View the official record on ClinicalTrials.gov

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