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Monoclonal Antibodies

Daratumumab for Leukemia

Phase 2
Recruiting
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 64
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a drug called daratumumab-hyaluronidase can treat T-ALL in patients who have a certain type of cancer that has come back after treatment.

Who is the study for?
This trial is for people with T-cell ALL who still have cancer cells after chemotherapy (MRD ≥ 10-4). They can't be pregnant or breastfeeding, must not have severe heart disease, active brain cancer involvement, uncontrolled HIV/HBV/HCV infections, or need strong drugs for GVHD. Good organ function and a performance status of 0-2 are required.
What is being tested?
The study tests daratumumab-hyaluronidase injection in patients with T-cell ALL who haven't responded well to chemotherapy. It aims to see if this treatment can eliminate the remaining cancer cells that standard therapy didn't get rid of.
What are the potential side effects?
Possible side effects include allergic reactions at the injection site, fatigue, nausea, lowered blood cell counts increasing infection risk, potential liver issues indicated by changes in certain blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I have T cell ALL and am in remission after intensive chemotherapy.
Select...
My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
Select...
I am able to get out of my bed or chair and move around.
Select...
My test shows minimal residual disease is present at a significant level.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
My blood cancer is in remission but still shows minimal signs of disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Remission (CR)
Complete Remission incomplete (CRi)
Complete Response with Partial Count Recovery (CRh)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Course 1Experimental Treatment1 Intervention
Daratumumab-hyaluronidase

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
269 Previous Clinical Trials
151,869 Total Patients Enrolled
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,365 Total Patients Enrolled
Shira Dinner, MDStudy ChairNorthwestern
2 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05289687 — Phase 2
T-Cell Lymphoblastic Leukemia Research Study Groups: Course 1
T-Cell Lymphoblastic Leukemia Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05289687 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289687 — Phase 2
~12 spots leftby Jun 2027
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