RECRUITING

Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL

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Conditions

T-cell Acute Lymphoblastic Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.

Official Title

A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL

Quick Facts

Study Start:2023-05-25
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05289687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10-4.
  3. * Institution must have received central MRD status test results confirming persistent or recurrent MRD ≥ 10-4 by flow cytometry.
  4. * Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day.
  5. * Patient must have an ECOG performance status 0-2.
  6. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 registration to rule out pregnancy.
  7. * Patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue to 3 months after the last dose of protocol treatment. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or donating eggs while on study treatment and for 3 months after the last dose of protocol treatment.
  8. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  9. * Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to Step 1 registration).
  10. * Absolute neutrophil count (ANC) ≥ 750/μL
  11. * Platelets ≥ 75,000/μL
  12. * Total or Direct bilirubin ≤ 2 mg/dL
  13. * AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN
  14. * Creatinine ≤ 1.5 x institutional ULN or Creatinine Clearance \> 30 ml/min
  15. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
  16. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  17. * 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.
  18. * Patients with prior CNS involvement are eligible as long as they do not have active CNS involvement at time of Step 1 registration.
  19. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  20. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Shira Dinner, MD
CONTACT
312-695-6180
shira.dinner@nm.org
Talha Badar, MD
CONTACT
904-953-7556
badar.talha@mayo.edu

Principal Investigator

Shira Dinner, MD
STUDY_CHAIR
Northwestern

Study Locations (Sites)

Northwestern
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Eastern Cooperative Oncology Group

  • Shira Dinner, MD, STUDY_CHAIR, Northwestern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-25
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2023-05-25
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • T-cell Acute Lymphoblastic Leukemia