Status:
COMPLETED
Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
In this study the investigators investigate a cell therapy strategy that could harness allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators have designed a novel l...
Detailed Description
This is a single center phase II trial designated to expand donor NK cells and induce remissions in patients with refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) using che...
Eligibility Criteria
Inclusion
- Patients of any age with diagnosis of:
- Relapsed/refractory lymphoma (B cell non-Hodgkin) who have lack of objective response to at least two prior chemotherapy regimens
- Relapsed chronic lymphocytic leukemia with high risk features: lack of objective response or relapse within 6 months following nucleoside-analogue based chemotherapy regimen or patients with 17p deletion CLL who lacked objective response to at least 1 preceding chemotherapy regimen
- Available related HLA haploidentical NK cell donor by at least Class I serologic typing at the A\&B locus (age 12-75 years)
- Karnofsky \> 70% for patients 16 years and older and Lansky play score \> 50 for patients under 16 years of age
- Measurable disease based on modified Response Evaluation Criteria in Solid Tumors (RECIST)
- Have acceptable organ function as defined within 28 days of enrollment:
- Hematologic: platelets ≥ 80,000 x 10\^9/L; hemoglobin ≥ 9 g/dL, unsupported by transfusions within 7 days; absolute neutrophile count (ANC) ≥ 1000 x 10\^9/L, unsupported by Granulocyte colony-stimulating factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) for 10 days or Neulasta for 21 days - the hematologic requirements are waived for patients with inadequate counts due to known bone marrow involvement by disease who are otherwise eligible
- Renal: calculated glomerular filtration rate (GFR) \> 50 ml/min
- Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 x upper limit of normal and total bilirubin ≤3 mg/dl - hepatic requirements are waived for patients with known disease involvement in the liver if otherwise eligible
- Pulmonary function: \>40% corrected Carbon Monoxide Diffusing Capacity (DLCO) and Forced expiratory volume in one second (FEV1) (oxygen saturation \[\>92%\] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
- Cardiac: no symptoms of uncontrolled cardiac disease, left ventricular ejection fraction ≥ 40%
- Able to be off prednisone or other immunosuppressive medications for at least 3 day prior to Day 0 (excluding denileukin diftitox pre-medications)
- Sexually active women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
- Voluntary written consent
Exclusion
- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 14 days prior to enrollment to rule out pregnancy. Women of childbearing age must use appropriate contraceptive method.
- Active central nervous system (CNS) lymphoma/leukemia - Patients with prior CNS involvement are eligible provided that it has been treated and is in remission.
- Active serious infection (pulmonary infiltrates or lesions are allowed only after the appropriate diagnostic testing is negative for infection or appropriate therapy was initiated for probable infection)
- Pleural effusion large enough to be detectable on chest x-ray (CXR)
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
- Active concurrent malignancy (except skin cancer)
- Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder
- Positive HBsAg. If HBcAb is positive, Hepatitis B DNA by PCR will be evaluated. Positive anti HBcAb with an undetectable viral load does not exclude the patient.
- Any investigational therapy in the past 30 days
- Patients following allogeneic stem cell transplantation are eligible in the absence of graft versus host disease and are off immunosuppression for at least 30 days
- Known allergy to any of the study agents
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01181258
Start Date
August 1 2010
End Date
July 1 2016
Last Update
February 6 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455