- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019640
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
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
Study Overview
Status
Conditions
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
|
Given IV
Other Names:
Given IV
Other Names:
Given SC
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo stem cell transplant
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related Mortality Within 30 Days (TRM30)
Time Frame: Up to 30 days
|
Participants that had Treatment-related mortality within 30 days.
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Survived
Time Frame: From the time of transplant, assessed up to day 180
|
Number of Participants Who Survived at day 180.
|
From the time of transplant, assessed up to day 180
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Recurrence
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dermatologic Agents
- Adjuvants, Immunologic
- Keratolytic Agents
- Etoposide
- Etoposide phosphate
- Antibodies
- Lenalidomide
- Podophyllotoxin
- Immunoglobulins
- Rituximab
- Lenograstim
- Melphalan
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Cytarabine
- Carmustine
- Mechlorethamine
- Nitrogen Mustard Compounds
Other Study ID Numbers
- 2015-0751 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01239 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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