Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
NCT ID: NCT05289687
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2023-05-25
2027-06-30
Brief Summary
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Detailed Description
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The primary objective of this study is to evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL in hematologic morphologic complete remission or complete remission with incomplete hematologic recovery. The secondary objectives include; evaluation of morphologic relapse free survival (RFS), evaluation of overall survival (OS), assessment of the the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase, assessment of adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL, and assessment of flow cytometry based MRD status on Day 64 of treatment or upon count recovery for patients that receive chemotherapy in addition to daratumumab-hyaluronidase during Course 1A.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Course 1
Daratumumab-hyaluronidase
Daratumumab / Hyaluronidase Injection
Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22
Daratumumab / Hyaluronidase Injection
Patients that are MRD Negative on Day 29 will receive daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57.
Daratumumab / Hyaluronidase Injection
Patients that remain MRD positive on Day 29 will receive a combination of daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57 and chemotherapy selected from the combinations listed below:
* Cytarabine 3000 mg/m2, IV, Every 12 hours for 4 doses on Days 37 and 38
* Methotrexate 1000 mg/m2, IV, Over 24 hours on Day 36
OR
* Methotrexate, Starting dose 100 mg/m2, IV, Days 36, 46, 56
* Vincristine, 1.5 mg/m2 (2 mg cap), IV, Days 36, 46, 56
* Pegaspargase, 2000 IU/m2 (Capped at 3750 IU), IV Days 37, 57
* Methotrexate 15 mg, IT, Days 36, 56
Daratumumab / Hyaluronidase Injection
All patients with MRD negative response after completion of previous course are eligible for daratumumab-hyaluronidase 1800mg/ 30,000 units every 2 weeks on Days 1,15, 29, 43, 57, 71, 85, and 99 for 8 doses.
Interventions
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Daratumumab / Hyaluronidase Injection
Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22
Daratumumab / Hyaluronidase Injection
Patients that are MRD Negative on Day 29 will receive daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57.
Daratumumab / Hyaluronidase Injection
Patients that remain MRD positive on Day 29 will receive a combination of daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57 and chemotherapy selected from the combinations listed below:
* Cytarabine 3000 mg/m2, IV, Every 12 hours for 4 doses on Days 37 and 38
* Methotrexate 1000 mg/m2, IV, Over 24 hours on Day 36
OR
* Methotrexate, Starting dose 100 mg/m2, IV, Days 36, 46, 56
* Vincristine, 1.5 mg/m2 (2 mg cap), IV, Days 36, 46, 56
* Pegaspargase, 2000 IU/m2 (Capped at 3750 IU), IV Days 37, 57
* Methotrexate 15 mg, IT, Days 36, 56
Daratumumab / Hyaluronidase Injection
All patients with MRD negative response after completion of previous course are eligible for daratumumab-hyaluronidase 1800mg/ 30,000 units every 2 weeks on Days 1,15, 29, 43, 57, 71, 85, and 99 for 8 doses.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Shira Dinner, MD
Role: STUDY_CHAIR
Northwestern University
Locations
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Northwestern
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Shira Dinner, MD
Role: primary
References
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Other Identifiers
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EA9213
Identifier Type: -
Identifier Source: org_study_id