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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

Study 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.Check my eligibility
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.See study design
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.
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I have T cell ALL and am in remission after intensive chemotherapy.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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I am able to get out of my bed or chair and move around.
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My test shows minimal residual disease is present at a significant level.
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My hepatitis B virus load is undetectable with treatment.
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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

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

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
268 Previous Clinical Trials
150,810 Total Patients Enrolled
Janssen, LPIndustry Sponsor
158 Previous Clinical Trials
304,940 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the potential benefits of using Daratumumab / Hyaluronidase Injection outweigh any possible risks?

"As this is a Phase 2 clinical trial, our team has evaluated the safety of Daratumumab / Hyaluronidase Injection to be at a level 2 due to its lack of efficacy data."

Answered by AI

How many individuals have enrolled in the experiment thus far?

"Indeed, the data hosted on clinicaltrials.gov proves that this medical trial is actively searching for participants. The study was initially shared on June 16th 2022 and later updated a day after. It requires 20 individuals to be enrolled from one centre."

Answered by AI

Is there any availability for people to participate in this research experiment?

"Indeed, this research project is still seeking participants. The trial was originally submitted on June 16th 2022 and underwent an amendment one day later."

Answered by AI
Recent research and studies
~8 spots leftby Oct 2024