Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Mantle Cell Lymphoma; Recurrent Indolent Adult Non-Hodgkin Lymphoma; Refractory Indolent Adult Non-Hodgkin Lymphoma; Refractory Follicular Lymphoma; Recurrent Follicular Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma
• Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Carmustine; Biological: Cord Blood-derived Expanded Allogeneic Natural Killer Cells; Drug: Cytarabine; Drug: Etoposide; Biological: Filgrastim; Drug: Lenalidomide; Drug: Melphalan; Biological: Rituximab

• Registration Number: NCT03019640
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This phase II trial studies the side effects of cord blood-derived expanded allogeneic natural killer cells (umbilical cord blood natural killer \[NK\] cells), rituximab, high-dose chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). I...

Detailed Description

PRIMARY OBJECTIVE:

I. To establish the safety of this treatment by determining its treatment-related mortality (TRM) within 30 days.

SECONDARY OBJECTIVES:
...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Study Start: 2017-10-10
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Results First Submitted: 2022-08-24
• Status Verified: 2022-12
• Results First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Results First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation:

  • Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment
  • Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment
  • Chemosensitive mantle-cell lymphoma in first or later line of treatment

• Estimated serum creatinine clearance >= 60 ml/min and a normal serum creatinine for age

• Serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit of normal (ULN)

• Total bilirubin and alkaline phosphatase (ALP) =< 2 x ULN or =< 3 x ULN for Gilbert's disease

• Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion lung capacity (DLCO) (corrected for hemoglobin [Hgb]) >= 50% of the predicted value

• Left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease

• Performance status < 2 (Eastern Cooperative Oncology Group [ECOG])

• Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential

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Exclusion Criteria

• Primary central nervous system (CNS) lymphoma
• Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =< grade (G) 1
• Prior whole brain irradiation
• Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
• Active infection requiring parenteral antibiotics
• Human immunodeficiency virus (HIV) infection
• Radiation therapy in the month prior to enroll
• Breastfeeding females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (chemotherapy, NK infusion, stem cell transplant)	Cord Blood-derived Expanded Allogeneic Natural Killer Cells	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Autologous Hematopoietic Stem Cell Transplantation	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Filgrastim	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Rituximab	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Lenalidomide	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Carmustine	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Cytarabine	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Etoposide	See Detailed Description.
Treatment (chemotherapy, NK infusion, stem cell transplant)	Melphalan	See Detailed Description.

Primary Outcome Measures

Name	Time	Method
Treatment-related Mortality Within 30 Days (TRM30)	Up to 30 days	Participants that had Treatment-related mortality within 30 days.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Survived	From the time of transplant, assessed up to day 180	Number of Participants Who Survived at day 180.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States