Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether daratumumab-hyaluronidase can treat T-cell acute lymphoblastic leukemia (T-ALL), a blood cancer. It is for people who still have small amounts of cancer, or whose cancer returns at very low levels, after chemotherapy.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Must have T-ALL in remission after at least 2 rounds of intensive chemotherapy. Remission means the cancer has mostly cleared, though blood counts may not have fully recovered.
- Must still have, or again have, at least 1 cancer cell per 10,000 cells tested. A central lab must confirm this small amount of cancer, called minimal residual disease (MRD).
- Must be able to care for yourself and be out of bed for at least half of waking hours. Blood tests within 7 days before registration must meet the study’s blood cell, liver, and kidney limits.
- A past donor stem cell transplant is allowed. You cannot have graft-versus-host disease, where donor cells attack your body, that needs ongoing immune-suppressing treatment. Prednisone up to 10 mg daily is allowed.
- If you can become pregnant, you need a negative pregnancy test within 14 days before registration. Use effective birth control or avoid sex during the study and for 3 months after the last dose. Do not donate sperm or eggs during that time.
- Must understand and agree to join in writing. People who have trouble making decisions may qualify with a legal representative, caregiver, or family member available.
- HIV must be controlled with treatment, with no virus detected within 6 months before registration. Hepatitis B must have no virus detected, with treatment if needed. Hepatitis C must be cured or have no virus detected during treatment.
- Past cancer in the brain or spinal cord is allowed only if it is no longer active. Other cancers must not affect study safety or results. People with heart disease, heart symptoms, or past heart-damaging treatment need a heart check and must meet the study’s heart function limit.
Who can't join
- Cannot be pregnant or breastfeeding because the treatment may harm an unborn baby or a nursing infant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10-4. * Institution must have received central MRD status test results confirming persistent or recurrent MRD ≥ 10-4 by flow cytometry. * 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. * Patient must have an ECOG performance status 0-2. * 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. * 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. * 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. * Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to Step 1 registration). * Absolute neutrophil count (ANC) ≥ 750/μL * Platelets ≥ 75,000/μL * Total or Direct bilirubin ≤ 2 mg/dL * AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN * Creatinine ≤ 1.5 x institutional ULN or Creatinine Clearance \> 30 ml/min * 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. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * 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. * Patients with prior CNS involvement are eligible as long as they do not have active CNS involvement at time of Step 1 registration. * 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. * 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. Exclusion Criteria: -Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Study sites (1)
IL
- Northwestern · Chicago, IL 60611Shira Dinner, MD · Study contact · 312-695-2120 · shira.dinner@nm.orgMore trials in Chicago