Hematology: Clinical Studies Open For Enrollment
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Eligibility
- Subject is 30 years of age or younger
- Diagnosis of Homozygous Hemoglobin S Disease or Heterozygous Hemoglobin Sickle Cell (SC) or S 0/+ thalassemia, or Sickle/variant resulting in Chronic Hemolytic Anemia with hemoglobin (HgB) less than or equal to 10 mg/dL
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT00408447
Principal Investigator
Mitchell S. Cairo, MD
Contact for Study Screening
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Enrollment Status: Enrolling
Principal Investigator
Jordan Brittni Milner, MD
Contact for Study Screening
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Eligibility
- Age: less than or equal to 39 years
- Diagnosis: T-cell acute lymphoblastic leukemia in second or subsequent remission (less than or equal to 5% blasts).
- Relapsed T-cell lymphoblastic lymphoma with complete response after reduction therapy.
- Donor Status: Planned allogeneic stem cell transplantation with donor identified.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04972942
Principal Investigator
Mitchell S. Cairo, MD
Contact for Study Screening
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Eligibility
- Male or Female Age ≤ 25 years
- An available related HLA-haploidentical donor that is determined to be the most appropriate donor for the patient by the treating physician
- AML in CR1 (defined as <5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features
- Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3
- AML secondary to select germline marrow failure disorders (with exception of Fanconi Anemia) may be eligible but require approval from Protocol Chairs prior to enrollment
- Exclusion Criteria: for matched healthy controls; Active extramedullary disease, Unresolved/ongoing and serious viral, bacterial, or fungal infection despite appropriate treatment, Prior allogeneic transplant and Patients with Fanconi Anemia and Down syndrome
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04836390
Principal Investigator
Aliza Gardenswartz, MD
Contact for Study Screening
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Eligibility
- Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria.
- Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant.
- Subject is ≥ 18 years of age at the time of signing the ICF.
- Clinically stable
- Exclusion Criteria:
- Has a hypersensitivity to the active substance or to any of the excipients
- No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
- Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator’s judgement
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04771078
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
- Subject was prescribed lisocabtagene maraleucel (liso-cel) for a diagnosis that is approved per local prescribing information, per treating physician assessment.
- Subject is ≥ 18 years of age at the time of signing the informed consent form.
- Subject had a subject-specific batch of liso-cel manufactured intended for commercial treatment; however, the final manufactured product did not meet the local commercial release criteria.
- Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
- Subject is clinically stable, has recovered from any prior toxicities which places the subject at clinical risk prior to receiving LD chemotherapy, and has adequate bone marrow function to receive LD chemotherapy. The treating physician is advised to contact the Medical Monitor in the event there is any concern regarding administration of LD chemotherapy.
- Females of childbearing potential must:
- Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.
- Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming liso-cel administration.
- Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming liso-cel administration.
- There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with liso-cel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
- Male subjects must:
- Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming liso-cel administration even if the subject has undergone a successful vasectomy.
- There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with liso-cel. Any decision regarding contraception after infusion should be discussed with the treating physician
- Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming liso-cel administration.
- Exclusion Criteria:
- Subject has a hypersensitivity to the active substance or to any of the excipients.
- Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming liso-cel.
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator’s judgement.
- Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator’s judgement
- Pregnant or nursing women or has intention of becoming pregnant during the study.
- Subjects with primary central nervous system (CNS) lymphoma (note: subjects with secondary CNS involvement are allowed on study).
- Subject has uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation
- Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming liso-cel administration.
- Subject has active acute or chronic graft-versus-host disease (ie, GVHD)
- Subject should not be actively receiving anticancer treatment that would, in the opinion of the treating physician, either increase the risk of AEs associated with LD chemotherapy or CAR T therapy or interfere with site routine care treatment plan associated with CAR T therapy. The treating physician is advised to consult with the Medical Monitor for case discussion if needed.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04400591
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening