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

NCT07021677 | Recruiting Phase 2 DMC

• 1 other identifier: 900938
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab?
2. 2.Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab?
3. 3.Whether addition of daratumumab can affect the risk of progression or death at 1-year?
4. 4.Whether daratumumab is safe to use?

Conditions

T Acute Lymphoblastic Leukemia

Keywords

daratumumab; T-Acute lymphoblastic leukemia; minimal residual disease; MRD; Post induction MRD

Outcome Measures

Primary Outcomes (1)

• MRD negativity

  To determine the MRD negativity rates after two doses of weekly intravenous daratumumab as a single agent for MRD positive T-ALL

  "week 3 after Daratumumab initiation"

Secondary Outcomes (3)

• To determine cumulative incidence of MRD negativity

  "Upto week 5 after Daratumumab initiation"

• Progression free survival

  "1-year after initiation of daratumumab"

• Adverse events

  "From day of initiation of daratumumab till four weeks after the last dose of daratumumab"

Study Arms (1)

Single Arm

OTHER

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

Drug: Daratumumab Injection

Interventions

Daratumumab Injection DRUG

Patients will receive intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen

Also known as: Darzalex

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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)

You may not qualify 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.
• Pregnant or breastfeeding female
• HBsAg positive or HBV-DNA positivity

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Dr.Sumeet Mirgh

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sumeet Mirgh, MD, DM

  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumeet Mirgh, MD, DM

CONTACT

91-8130140245; drsumeetmirgh@gmail.com

Anant Gokarn, MD, DM

CONTACT

91-8097295540; anantgokarn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: June 15, 2025
• Study Start: August 28, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)