Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Mantle Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Indolent Adult Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Indolent Adult Non-Hodgkin Lymphoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 15 years and 70 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To establish the safety of this treatment by determining its treatment-related mortality (TRM) within 30 days. SECONDARY OBJECTIVES: I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS). III. To quantify duration of infused allogeneic umbili...

PRIMARY OBJECTIVE: I. To establish the safety of this treatment by determining its treatment-related mortality (TRM) within 30 days. SECONDARY OBJECTIVES: I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS). III. To quantify duration of infused allogeneic umbilical cord blood (UCB)-derived natural killer (NK) cells in the recipient. OUTLINE: PREPARATIVE REGIMEN: Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7. NK-CELL INFUSION: Patients receive cord blood-derived expanded allogeneic NK cells IV over 1 hour on day -5 in the absence of disease progression or unacceptable toxicity. STEM CELL TRANSPLANT: Patients undergo stem cell transplant IV over 30-60 minutes on day 0 in the absence of disease progression or unacceptable toxicity. POST-TRANSPLANT: Patients receive filgrastim subcutaneously (SC) QD beginning on day +5. Treatment continues until white blood cell count recovers in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 100, and 180 days.

Tracking Information

NCT #
NCT03019640
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Yago L Nieto M.D. Anderson Cancer Center