Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"

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-ye

Trial Details

NCT ID

NCT07021677

Phase

PHASE2

Sponsor

Tata Memorial Centre

Status

RECRUITING

Cancer Type

Leukemia

Interventions

• Daratumumab Injection

Locations (sample)

• Navi Mumbai, Maharashtra, India|19.03681,73.01582

Key Eligibility Criteria

• 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

For full eligibility, visit ClinicalTrials.gov.

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