Study to Evaluate Serial Amnioinfusions as Therapy for Pulmonary Hypoplasia in Fetuses with Renal Failure or Severe Renal Anomalies

Overview

About this study

The purpose of the study is to investigate whether amnioinfusion intervention for fetuses diagnosed with intrauterine renal failure will be safe and feasible.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 years or greater.
  • For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the “Other B-NHL” cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).

Disease-specific cohorts:

  • FL grade 1-3a cohort: patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
  • DLBCL cohort: patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent. Patients with de novo DLBCL or DLBCL that is transformed from a lower grade neoplasm (eg, FL or CLL) may be enrolled. For patients with transformed DLBCL, prior systemic therapies administered for the lower grade neoplasm will be considered among the prior lines of therapy for the purpose of determining eligibility.
  • MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed after or are refractory to a BTK inhibitor. It is not necessary for BTK inhibitor therapy to comprise the most recent line of treatment. Patients may also be enrolled who have relapsed or have disease refractory to prior systemic therapy, or who have demonstrated intolerance to BTK inhibitor therapy and who have progressed after other systemic therapy.
  • MZL cohort: patients with MZL that has relapsed or is refractory to at least 1 prior line of systemic therapy.
  • Additional Inclusion Criteria may apply.

Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
  • Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter. 
  • History of allogeneic stem cell transplantation.
  • Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy.
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug.
  • History of neurodegenerative condition or CNS movement disorder. Patients with a history seizure within 12 months prior to study enrollment are excluded. 
  • Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential.
  • Additional Exclusion Criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mauro Schenone, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available