se of a new medicine Daratumumab to treat left-over cancer in a blood cancer called T-Acute Lymphoblastic Leukemia
- Conditions
- Health Condition 1: D728- Other specified disorders of whiteblood cells
- Registration Number
- CTRI/2023/07/054825
- Lead Sponsor
- ady Tata Memorial Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <2 times upper limit of normal (ULN), Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) <3 ULN
7. Subject ready to sign an informed consent form
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 <40%
6. Human immunodeficiency virus (HIV) positive.
7. Pregnant or breastfeeding female
8. HBsAg positive or HBV-DNA positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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