Leukemia: Clinical Trials Open for Enrollment
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Eligibility
- Subject is between one year and 31 years of age
- Patients must weigh at least 10 kilograms at the time of the study enrollment
- Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03719105
Principal Investigator
Aliza Gardenswartz, MD
Contact for Study Screening
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Eligibility
- Subject is between one year and 30 years of age
- Disease: B-ALL
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03914625
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between one year and 31 years of age
- B-cell Lymphoblastic Leukemia
- B-cell Lymphoblastic Lymphoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03914625
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is no older than 22 years of age
- Newly diagnosed with de novo AML with or without extramedullary disease
- Patient must have one of the following:
- At least 20% bone marrow blasts (obtained within 14 days prior to enrollment)
- Less than 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
- A complete blood count (CBC) documenting the presence of at least 1,000/uL
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04293562
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between two and 21 years of age
- Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03007147
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is no older than 25 years of age
- CML-CP at original diagnosis
- Molecular remission (MR) with a BCR-ABL1 level of no more than 0.01% BCR-ABL1
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03817398
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is 30 years of age or younger
- Recurrent or refractory Hodgkin or non-Hodgkin Lymphoma and have failed at least one line or prior therapy
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05255601
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Subject is 6 months to 21 years of age
- Diagnosed with ALL, AML or MDS and no sibling donor
- Has not received a prior allogeneic hematopoietic stem cell transplant
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05457556
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Relapsed B cell ALL with BM blasts ≥5%
- Refractory B cell ALL as defined by at least one of the following criteria:
- Subjects who have failed to achieve a bone marrow CR after at least two prior lines of frontline therapy with curative intent (refractory disease; including persistent, positive MRD by flow cytometry >0.01%)
- Subjects previously in remission who have failed to achieve a CR after at least 1 cycle of standard chemotherapy for relapsed leukemia (including persistent, positive MRD by flow cytometry >0.01%)
- Subjects with Ph+ ALL who are intolerant of or have failed 3 lines of TKI therapy, or if TKI therapy is contraindicated
- Leukemia blasts in bone marrow are CD19+ as determined by standard flow cytometry on samples obtained within up to 28 days of VNX-101 dosing
- Part 1: Bone marrow blasts >0.01% to <5% by flow cytometry prior to VNX-101 dosing (a priori or post cytoreductive therapy). Part 2: Bone marrow blasts >0.01% to <50% by flow cytometry prior to VNX-101 dosing (a priori or post cytoreductive therapy)
- Age
- Part 1: ≥18 and ≤90 years at time of informed consent
- Part 2: ≥13 and ≤90 years at time of informed consent
- Ineligible for or declined to receive, or failed to respond to, FDA-approved CD19-directed CAR-T cell therapies based on the indications and contraindications for use of tisagenlecleucel (KYMRIAH®) and brexucabtagene autoleucel (TECARTUS®) as specified in their respective labeling; or declined to receive FDA-approved CD19-directed CAR-T cell therapies; or have already received and failed to respond to or relapsed after response to an FDA-approved CD19-directed CAR-T cell therapy
- Absolute T cell count >200/mm3 within 3 days prior to VNX-101 dosing
- Lansky >50% (<16 years) / ECOG performance status <3 (≥16 years)
- Life expectancy >3 months
- Exclusion criteria:
- Subjects at high risk for AEs of special interest:
- Hepatotoxicity: AST or ALT >2 × ULN
- TMA: Prior history of TMA or HUS
- Cardiomyopathy: History of inflammatory-mediated cardiomyopathy even if resolved, history of chemotherapy-induced cardiomyopathy requiring cardiac-directed therapies, and/or EF<40%
- Dorsal root ganglion neuropathy: Evidence of sensory neuropathy (numbness, pain, proprioceptive loss, loss of deep tendon reflexes) not attributable to prior vinca alkaloid therapy
- Infection or any other severe systemic disease, medical, surgical, or other condition that, in the Investigator’s opinion, could adversely affect the safety of the subject, interfere with the subject’s compliance with the protocol, or impair the assessment and interpretation of study results.
- Administration of any unlicensed or investigational product within 5 half-lives prior to VNX-101 dosing.
- Sexually active males and WOCBP unable to commit to highly effective contraception for the duration of the study and 60 months post VNX-101
- Pregnant or nursing (lactating) women
- Active or latent hepatitis B or active hepatitis C (tested within 8 weeks of screening or during screening), or any uncontrolled infection at screening
- HIV positive test within 8 weeks of screening or during screening
- Allogeneic HSCT within 3 months of VNX-101 dosing
- Subjects with acute GvHD Grade 2-4 or chronic GvHD of any grade
- Severe obesity: BMI >40. For subjects with BMI >30, the VNX-101 dose will be calculated based on an alternative body weight determination that assumes a maximum permissible BMI of 30 kg/m2. For example, a subject who is 6 feet 2 inches and weighs 168 kg (BMI 47.5) would receive a VNX-101 dose based on an alternative body weight of 106 kg (which is the body weight associated with a BMI of 30 for an individual who is 6 feet 2 inches tall).
- Subjects at high risk for AEs of special interest:
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT06533579
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment
- All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321
- Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization [WHO] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage
- Diagnostic immunophenotype: Leukemia cells must express CD19
- Exclusion Criteria
- Patients with Down Syndrome
- Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
- Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
- Steroid pretreatment:
- PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
- Inhaled and topical steroids are not considered pretreatment
Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred > 28 days before enrollment does not affect eligibility
- Intrathecal cytarabine or methotrexate:
- An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
- An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
- Hydroxyurea:
- Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
- Steroid pretreatment:
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06317662
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Patients must be > 365 days and < 18 years (for AIEOP-BFM), > 365 days and < 22 years (for Children’s Oncology Group [COG]) and > 365 days and < 46 years (for ALLTogether sites) at the time of enrollment
- Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
- Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5′ fusion partner genes is not required for study enrollment
- Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy
- Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vincristine
- Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
- Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
- For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):
- Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
- Measured GFR ≥ 50 mL/min/1.73 m^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard
- For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight
- Direct bilirubin < 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- Exclusion Criteria
- Known history of chronic myeloid leukemia (CML)
- ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- Down syndrome (trisomy 21)
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment
- Lactating females who plan to breastfeed their infants
- Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol
NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer - Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
- Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
- Patients with known Charcot-Marie-Tooth disease
- Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement
NOTE: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved - HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06124157
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening