Lymphoma: Clinical Trials Open for Enrollment
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Eligibility
- Subject is between three years and 31 years of age
- In first or second relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT02393157
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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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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Enrollment Status: Enrolling
Principal Investigator
Aliza Gardenswartz, MD
Contact for Study Screening
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Eligibility
- Subject is between one month and 17 years of age
- Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
- Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04570423
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05253495
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is at least 18 years of age
- Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least one line of prior therapy
- Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least two lines of prior therapy
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05139017
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Subject is at least two years of age
- Primary mediastinal B-cell lymphoma (PMBCL)
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04759586
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male or female at least 15 years of age
- Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL)
Enrollment Status: Enrolling
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male and female, Subjects must be at least 18 years old
- Subject is willing and able to comply with procedures required in this protocol
- Subject must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug
- Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator’s discretion should be applied
- Subject must have available adequate fresh or paraffin-embedded tissue at Screening
- Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms
- Subject must have R/R disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis
- Subject must have an ECOG performance status score of 0 to 2
- Life expectancy > 3 months on SOC treatment at the time of enrolling in the study
- Exclusion Criteria
- Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx
- Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness
- Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days
- Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
- Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Enrollment Status: Actively enrolling
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Male or Female must be ≥ 3 years and ≤ 39 years of age at the time of enrollment
- Newly diagnosed patients with histologically or cytologically proven newly diagnosed cHL according to WHO Classification who meet the following criteria are eligible:
COHORT 1:- Classical Hodgkin lymphoma (ICD-O 9650/3, 9663/3, 9651/3, 9652/3, 9653/3)
- COHORT Ia: stage I-IIA with bulky ± E, I-IIB no bulky ± E, IIIA ± E (INTERMEDIATE RISK)
- COHORT Ib: stage IIB with bulky ± E, IIIA with bulky ± E, IIIB, IV (HIGH RISK)
- Adequate organ function
- Exclusion Criteria
- Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal
- Lactating females unless they have agreed not to breastfeed their infants
- Any patient with uncontrolled infection prior to study entry
- Any patient known to have primary or acquired immunodeficiency and/or prior solid organ transplant
- Patients who have received any prior lymphoma directed therapy.
EXCEPTION: emergent steroid therapy will be eligible only if given ≤72 h prior to enrollment; mediastinal radiation therapy may be given prior to or concurrently (<1000 cGy) for superior vena cava (SVC) syndrome
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05253495
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening