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New treatment option for T Acute Lymphoblastic Leukemia
Official title Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"
ClinicalTrials.gov ID: NCT07021677
What this study is testing
What is Daratumumab Injection?
Daratumumab Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for t acute lymphoblastic leukemia.
Also referred to as Darzalex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- T-LBL (T-lymphoblastic lymphoma) without BM involvement
- Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- Presence of an active systemic infection, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \<40%
- Human immunodeficiency virus (HIV) positive.
See the full 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
- 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)
- T-LBL (T-lymphoblastic lymphoma) without BM involvement
- Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- Presence of an active systemic infection, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \<40%
- Human immunodeficiency virus (HIV) positive.
- Pregnant or breastfeeding female
- HBsAg positive or HBV-DNA positivity
The study team makes the final eligibility decision.
Where it's taking place
- Navi Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Navi Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.