Daratumumab to clear leftover T‑cell acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults (18–65) with newly diagnosed T‑ALL who are MRD positive (≥0.01%) after two phases of induction chemotherapy and whose disease expresses CD38 will receive intravenous daratumumab at 16 mg/kg. Participants get two weekly doses and will have a bone marrow MRD test one week after the second dose; patients who remain MRD positive may receive two additional weekly doses with repeat MRD testing. The trial tracks whether patients convert to MRD negativity after two or four doses, monitors safety and adverse events, and follows progression or death up to one year. Outcomes include MRD conversion rates, one‑year progression/death risk, and treatment tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults ≥18 - ≤65 years of age
2. Baseline diagnosis of T-ALL, including ETP-ALL
3. MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1
4. CD38 positive
5. Eastern cooperative oncology group (ECOG) performance status ≤2
6. Acceptable liver functions, as specified below:

   Total bilirubin \<2 times upper limit of normal (ULN); Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) \<3 ULN
7. Subject ready to sign an informed consent form
8. Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)

Exclusion Criteria:

1. T-LBL (T-lymphoblastic lymphoma) without BM involvement
2. Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
3. Patients with symptomatic obstructive airway disease, as per assessing clinician
4. Presence of an active systemic infection, as per assessing clinician
5. New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \<40%
6. Human immunodeficiency virus (HIV) positive.
7. Pregnant or breastfeeding female
8. HBsAg positive or HBV-DNA positivity

Where it's running

• Dr.Sumeet Mirgh
  Navi Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Sumeet Mirgh, MD, DM — Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre
• Study coordinator: Sumeet Mirgh, MD, DM
• Email: drsumeetmirgh@gmail.com
• Phone: 91-8130140245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.