NCT07021677RecruitingPhase 2
Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"
Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative. The main questions this study aims to answer are - 1. Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab? 2. Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab? 3. Whether addition of daratumumab can affect the risk of progression or death at 1-year? 4. Whether daratumumab is safe to use? Newly diagnosed patients of T-ALL who are MRD positive after two courses of induction chemotherapy will be eligible to receive daratumumab. These patients will receive two doses of weekly intravenous daratumumab at standard dose (16mg/kg), and will undergo repeat evaluation of MRD from bone marrow one week after the second dose of daratumumab. Patients who become MRD negative will continue chemotherapy as per institutional policy. Those who remain MRD positive will be eligible to receive two additional doses, and will undergo another bone marrow MRD testing one week after the fourth dose. Irrespective of the results after the fourth dose, patients will be continued on chemotherapy as per institutional policy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 6 Oct 2023
- Start date
- 28 Aug 2023
- Primary completion date
- 28 Aug 2026
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07021677
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 18
- From 28 Aug 2023 to the primary completion date, 28 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- Presence of an active systemic infection, as per assessing clinician
- Human immunodeficiency virus (HIV) positive.
- HBsAg positive or HBV-DNA positivity
Lab values
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \<40%
Other
- T-LBL (T-lymphoblastic lymphoma) without BM involvement
- Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
- Pregnant or breastfeeding female
Who the study is looking for
- Adults ≥18 - ≤65 years of age
- Baseline diagnosis of T-ALL, including ETP-ALL
- MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1
- CD38 positive
- Eastern cooperative oncology group (ECOG) performance status ≤2
- 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
- Subject ready to sign an informed consent form
- Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr.Sumeet Mirgh Coordinator of this site? Confirm its status | Navi Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.