RecruitingPhase 2NCT07021677

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


Sponsor

Tata Memorial Centre

Enrollment

18 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called daratumumab (commonly used in multiple myeloma) can eliminate remaining cancer cells (called minimal residual disease, or MRD) in adults with T-cell acute lymphoblastic leukemia (T-ALL) who are in remission but still have detectable cancer after initial chemotherapy. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with T-ALL (including ETP-ALL) - After two rounds of induction chemotherapy, you are in remission but still have measurable residual cancer cells (MRD positive, ≥0.01%) by flow cytometry - Your cancer cells test positive for CD38 (a protein on the cell surface) - Your liver function is within acceptable limits **You may NOT be eligible if...** - You have T-lymphoblastic lymphoma without bone marrow involvement - You have persistent cancer cells in your spinal fluid that haven't cleared - You have significant liver problems or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab Injection

Patients will receive intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen


Locations(1)

Dr.Sumeet Mirgh

Navi Mumbai, Maharashtra, India

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NCT07021677


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