Testing the use of Daratumumab-Hyaluronidase in Persistent or Recurrent T Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/T-LBL) following Treatment with Chemotherapy

Inclusion Criteria

• PREREGISTRATION (STEP 0):
• Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously. * NOTE: Bone marrow aspirate or peripheral blood must be submitted to Dr. Brent Wood’s laboratory at Children’s Hospital Los Angeles (CHLA) for central assessment of the establishment of MRD. Bone marrow must be from the first pull (initial or redirect needle) and specimens must contain sufficient blast cells. For adult patients (>= 18 years of age) if the bone marrow aspiration is not adequate or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood can be submitted regardless of peripheral blast percentage. For pediatric patients (< 18 years of age), only bone marrow aspirate will be acceptable to submit at preregistration. Dr. Brent Wood’s laboratory at Children’s Hospital Los Angeles will forward results within 48 hours (two business days) of receipt of the specimen to the submitting institution. Institutions will receive email notification once results are entered into Rave. * NOTE: If MRD status testing was performed previously as part of standard of care at Dr. Brent Wood’s laboratory, eligible patients can proceed to Step 1 registration once MRD status results are entered into Rave by CHLA within 48 hours (two business days) of Step 0 preregistration. Institutions will receive email notification once results are entered * NOTE: Patients that are MRD positive by Adaptive clonoSEQ testing must have bone marrow or peripheral blood collected and shipped to CHLA for central flow cytometry MRD testing, but do not need to await results to register for Step 1. Patients that are MRD negative by central laboratory flow cytometry, but found to be MRD positive by clonoSEQ testing sent by local institution will be eligible for Step 1 registration. clonoSEQ testing should be done as clinically indicated per institutional guidelines and report uploaded and entered in Rave by institution to allow Step 1 registration. Institutions will receive email notification once results are entered in Rave
• Patient must be >= 12 years of age and weigh >= 40 kg
• Patient must have documented T cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) and must be in first or later morphologic CR, CRh, CRi after a minimum of 2 blocks of intensive chemotherapy * Patients >= 65 years of age that the physician judges to be unfit for 2 blocks of intensive chemotherapy may enroll after one cycle of therapy as long as they are in CR, CRh, or CRi at least 28 days after initiation of ALL/LBL directed therapy
• REGISTRATION (STEP 1):
• Patients in morphologic CR, CRh, or CRi must have persistent or recurrent MRD >= 10^-4 that has been determined by central flow cytometry at CHLA OR determined by Adaptive clonoSEQ testing with result of >= 1 residual clonal cell per million nucleated cells
• 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
• Adult patient (>= 18 years of age) must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Pediatric patient (<18 years of age) must have Lansky Performance score of >= 50
• 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. 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. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• 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 and/or their parents or legal guardians 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
• Absolute neutrophil count (ANC) >= 750/uL (must be obtained =< 7 days prior to Step 1 registration)
• Platelets >= 75,000/uL (must be obtained =< 7 days prior to Step 1 registration)
• Total or direct bilirubin =< 2 mg/dL (must be obtained =< 7 days prior to Step 1 registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate-pyruvate transaminase [SGPT]) =< 3.0 x institutional upper limit of normal (ULN) (must be obtained =< 7 days prior to Step 1 registration)
• Adult patients (>= 18 years of age) must have a creatinine =< 1.5 x institutional ULN or creatinine clearance > 30 ml/min (must be obtained =< 7 days prior to Step 1 registration). Pediatric Patients (< 18 years of age and weigh >= 40 kg) must have a measured or calculated (plasma creatinine is also acceptable) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 ml/min/1.73 m^2 OR serum creatinine =< 1.5 x institutional upper limit of normal (ULN) OR serum creatinine (plasma creatinine is also acceptable) based on age/sex as follows: * 12 to < 13 years: 1.2 mg/dL (male) or 1.2 mg/dL (female) * 13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female) * <= 16 years < 18: 1.7 mg/dL (male) or 1.4 mg/dL (female) ** The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC27
• 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 central nervous system (CNS) involvement are eligible as long as they do not have active CNS involvement at time of Step 1 registration
• Patients with extramedullary involvement outside the CNS are eligible if they are asymptomatic from the lesions
• 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 who have controlled intermittent asthma or controlled mild persistent asthma are eligible
• Adult patients (>= 18 years of age) 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. Pediatric patients (< 18 years of age) must have adequate cardiac function confirmed with an echocardiogram (ECHO), MUGA, or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27% obtained within 6 months prior to Step 1 registration
• Adult patients (>= 18 years of age) FEV1 testing is only required if clinically indicated for patients suspected of having COPD. To be eligible, patients with suspected or proven chronic obstructive pulmonary disease (COPD) must have an FEV1 ≥50% of predicted normal obtained within 6 months prior to Step 1 registration. Pediatric patients (< 18 years of age) must not have uncontrolled asthma. For pediatric patients with a history of asthma, there must be no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry reading of > 92% on room air