Health Condition 1: D728- Other specified disorders of whiteblood cells
Conditions
Interventions
Intervention1: Daratumumab in patients who are positive for flow-cytometric minimal residual disease (MRD) after two phases of induction chemotherapy in T-ALL patients in CR-1: T-ALL patients in CR-1
Sponsors
Lady Tata Memorial Trust
Eligibility
Inclusion criteria
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 (=20% blasts) 5. Eastern cooperative oncology group (ECOG) performance status =2 6. Acceptable liver functions, as specified below: Total bilirubin 7. Subject ready to sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. T-LBL (T-lymphoblastic lymphoma) without BM involvement 2. Patients with central nervous system (positive CSF cytology at time of diagnosis of T-ALL) or 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 6. Human immunodeficiency virus (HIV) positive. 7. Pregnant or breastfeeding female 8. HBsAg positive or HBV-DNA positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the MRD negativity rates after two doses of weekly intravenous daratumumab as a single agent for MRD positive T-ALLTimepoint: After two doses of daratumumab | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine cumulative incidence of MRD negativity with upto 4 doses of daratumumab monotherapyTimepoint: After four doses of daratumumab;To determine incidence of adverse events (as per CTCAE v5.0 2017) after daratumumab therapyTimepoint: From the day of initiation of daratumumab till four weeks after the last dose of daratumumab;To determine progression free survival at 1 yearTimepoint: At 1 year after initiation of Daratumumab | — |
Countries
India
Contacts
Public ContactSumeet Mirgh
Tata Memorial Centre ACTREC (Advanced Centre for Treatment, Research and Education in Cancer)
Outcome results
None listed