Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00941928
Eligibility Criteria:
Inclusion Criteria:
1. Recipient Inclusion criteria (within 28 days of this protocol's lymphodepleting conditioning regimen and after donor and recipient consent-signing)
2. Diagnosis of CD22+ acute lymphoblastic leukemia that is a. refractory to therapy or b. in second or greater relapse without other standard therapeutic options
3. Patient may have been the recipient of an allogeneic hematopoietic stem cell transplant; however; there must be no evidence of Graft-versus-host disease (GVHD)
4. Off prednisone or other immunosuppressive medications for at least 3 days prior to both the lymphodepleting regimen and the NK infusion
5. Zubrod performance scale \</= 2 or Lansky performance scale \>/= 60
6. Adequate renal function defined as: Serum creatinine (Cr), for adults \</= 2 mg/dL, for children \</= 2 mg/dL or \</= 2 times upper limit of normal (ULN) for age (whichever is less). If abnormal renal function, then Cr clearance \>/= 60 mL/min/1.73 m\^2
7. Adequate liver function defined as: Total bilirubin \</= 2 mg/dL and serum glutamic-pyruvic transaminase (SGPT)/ alanine transaminase(ALT) \</= 5 \* ULN for age (unless Gilbert's disease or abnormal liver function due to primary disease)
8. Pulmonary symptoms controlled by medication and pulse oximetry \>/= 92% room air
9. Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized
10. Requirement of sexually active females and males to use any form of contraception considered effective and medically acceptable by the Investigator. \[Acceptable forms: birth control implants, birth control pills, a vasectomy (male surgical sterilization), or a double-barrier method (any 2 of the following in combination: intrauterine device (IUD), male or female condom with spermicidal gel, a diaphragm, a sponge, and/or cervical cap)\]
11. Negative serology for human immunodeficiency virus (HIV)
12. Donor must be related to recipient and is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C or Bw antigens
13. Donor must have infectious disease marker testing \[Hepatitis B, C, HIV, CMV, Syphilis (RPR), Chagas, HTLV, and West Nile Virus\] and CBC differential and platelet studies that meet standard medical eligibility criteria for allogeneic blood stem cell donation within 7 days of apheresis
14. Donor, if a female of childbearing potential (non-childbearing is defined as greater than one year post-menopause or surgically sterilized), must have a negative serum test to rule out pregnancy within 14 days of apheresis
15. Donor must meet standard medical eligibility criteria for allogeneic stem cell donation
Exclusion Criteria:
1. Exclusion criteria applies to both the initiation of conditioning regimen and to the NK infusion
2. Active central nervous system (CNS) leukemia
3. Active infection (defined as on antimicrobial therapy and or febrile)
4. Breast-feeding females
5. Currently using a ventilator or requiring supplemental oxygen
6. Currently undergoing dialysis
7. Currently using a Phase I, II, or III investigational agent. These agents should be stopped within 21 days of NK infusion
8. New detected cardiac arrhythmia not controlled with medical management within prior 72 hour period.
9. Hypotension requiring pressor support within prior 72 hour period
10. Uncontrolled infection defined as daily fever greater than or equal to 38.2°C within prior 24 hours and new positive culture for bacteria, fungus, or virus within 72 hours prior to NK -cell infusion, if clinically indicated
11. Taking corticosteroids by mouth or intravenously within prior 72 hour period
12. Ascites requiring paracentesis within prior 72 hour period. (If the patient requires paracentesis within 72 hours of NK cell infusion, they will not be eligible to receive the infusion.)
13. Seizure activity or clinically detectable encephalopathy or new focal neurologic deficits within prior 72 hour period
14. Donor has active infection (defined as on antimicrobial therapy and/or febrile) within 7 days of apheresis
15. Donor is pregnant female or breast-feeding female (within 7 days of apheresis)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00941928
Study Brief:
Protocol Section:
NCT00941928