Actively Recruiting
Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"
Led by Tata Memorial Centre · Updated on 2025-06-15
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years of age
- Diagnosed with T-acute lymphoblastic leukemia (including ETP-ALL)
- MRD positive (≥0.01%) by flow cytometry in bone marrow after two phases of induction chemotherapy in first complete remission
- CD38 positive expression on blasts (≥20%)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Acceptable liver function: total bilirubin less than 2 times upper limit of normal; AST and ALT less than 3 times upper limit of normal
- Able and willing to sign informed consent
- Patients with previously positive cerebrospinal fluid cytology who have cleared CSF by cytology or flow cytometry
You will not qualify if you...
- Diagnosed with T-lymphoblastic lymphoma without bone marrow involvement
- Persistently positive cerebrospinal fluid cytology after two phases of induction or baseline testicular involvement
- Symptomatic obstructive airway disease
- Active systemic infection
- New York Heart Association Class III or IV heart disease or left ventricular ejection fraction less than 40%
- HIV positive
- Pregnant or breastfeeding female
- Positive for hepatitis B surface antigen or hepatitis B virus DNA
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dr.Sumeet Mirgh
Navi Mumbai, Maharashtra, India, 410210
Actively Recruiting
Research Team
S
Sumeet Mirgh, MD, DM
CONTACT
A
Anant Gokarn, MD, DM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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