Lymphoma: Clinical Trials Open for Enrollment
-
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
-
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
-
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
-
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
-
Enrollment Status: Enrolling
Principal Investigator
Aliza Gardenswartz, MD
Contact for Study Screening
-
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05253495
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
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
-
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
-
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
-
Inclusion Criteria
- Male or female, Age between ≥ 6 and ≤ 29.99 years at the time of consent.
- Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative or guardian for pediatric subjects; given a copy of the informed consent form.
- Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
- Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.
- Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry. (Appendix XIV)
- Risk Factors: Patient must meet established low-risk factors:
- Stage at Diagnosis = IA, IIA
- ≥12 months from end of therapy
- OR 3-12 months from end of therapy with ≤3 cycles of treatment and no radiation
- NO B symptoms
- NO extra nodal disease at relapse
- NO relapse in a prior radiation field
- Stage at Diagnosis = IB, IIB, IIIA
- ≥12 months from end of therapy
- NO B symptoms
- NO extranodal disease at relapse
- NO relapse in a prior radiation field
- Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label.
- Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.
- Subjects 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.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Planned to undergo reinduction therapy and found to have a favorable response to one line of reinduction therapy. Patients who are refractory to initial reinduction attempts are considered high-risk and thus not eligible for Cell Product Administration and will be removed from study.
Exclusion Criteria
- Must be Deauville 1, 2 or 3 on FDG-PET imaging following reinduction therapy to be eligible for CAR T-cell production.
- Written informed consent to undergo cell procurement explained to, understood by and signed by the subject or legally authorized representative (or guardian for pediatric subjects); subject and/or legally authorized representative/guardian given a copy of informed consent form for cell procurement.
- Subject has life expectancy of ≥ 12 weeks.
- Current use of systemic corticosteroids at doses ≥10 mg (>0.5mg/kg) prednisone daily or its equivalent is not allowed; those receiving <10 mg (≤0.5mg/kg) daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. Physiologic replacement hydrocortisone at doses 6-12 mg/m²/day is allowed. Equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10 mg prednisone per day
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. Note: Females are considered of childbearing potential unless they are premenarchal or surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of premenarchal or postmenopausal status must be provided.
Enrollment Status: Open to Enrollment
Principal Investigator: Mitchell Cairo, MD
Contact for Study Screening: [email protected]