Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies

Completed · Phase 2

Conditions studied: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia

In brief

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 lymphodepleting conditioning regimen followed by infusion of donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory lymphoid malignancies.

Key facts

Study ID

NCT01181258

Run by

Masonic Cancer Center, University of Minnesota

People needed

16

Starts

2010-08-01

Expected to finish

2016-07-01

Last updated by the study team

2018-02-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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