Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT03019640|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||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||Phase 2|
I. To establish the safety of this treatment by determining its treatment-related mortality (TRM) within 30 days.
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.
PREPARATIVE REGIMEN: Participants 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. Participants who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
NK-CELL INFUSION: Participants 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: Participants undergo stem cell transplant IV over 30-60 minutes on day 0 in the absence of disease progression or unacceptable toxicity.
POST-TRANSPLANT: Participants 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, participants are followed up at 30, 100, and 180 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo stem cell transplant
Biological: Cord Blood-derived Expanded Allogeneic Natural Killer Cells
- Treatment-related mortality within 30 days (TRM30) [ Time Frame: Up to 30 days ]TRM30 will be estimated using a 95% credible interval assuming a beta(.50, .50) prior.
- Relapse-free survival (RFS) [ Time Frame: From the time of transplant assessed up to progression or relapse, assessed up to 3 years ]Unadjusted RFS will be estimated by the method of Kaplan and Meier.
- Overall survival (OS) [ Time Frame: From the time of transplant, assessed up to 3 years ]Unadjusted OS will be estimated by the method of Kaplan and Meier.
- Natural killer (NK) cell persistence [ Time Frame: Up to 14 weeks ]A Bayesian hierarchical regression model will be fit to the longitudinal NK cell data to assess its patterns over time and association with patient covariates, including type of lymphoma, age, and disease severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019640
|Contact: Yago Nietofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Yago L. Nieto 713-792-8750|
|Principal Investigator: Yago L. Nieto|
|Principal Investigator:||Yago Nieto||M.D. Anderson Cancer Center|