Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Eastern cooperative oncology group (ECOG) performance status ≤2

• 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

• Subject ready to sign an informed consent form

• Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)

Locations
Other Locations
India
Dr.Sumeet Mirgh
RECRUITING
Navi Mumbai
Contact Information
Primary
Sumeet Mirgh, MD, DM
drsumeetmirgh@gmail.com
91-8130140245
Backup
Anant Gokarn, MD, DM
anantgokarn@gmail.com
91-8097295540
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2026-08-28
Participants
Target number of participants: 18
Treatments
Other: Single Arm
This will be a single arm, open-label, prospective, interventional phase 2 study. T-ALL patients who are MRD positive post two courses of induction therapy (as per pediatric inspired protocol) will be eligible for this study
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov

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