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Chemotherapy

NK Cells for Leukemia

Phase 1
Waitlist Available
Led By Chitra M. Hosing, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 3 weeks, 1 month, and 4 months after the nk cell infusion
Awards & highlights

Study Summary

This trial is studying a possible new treatment for chronic lymphocytic leukemia. Researchers want to see if adding natural killer (NK) cells to standard chemotherapy can help treat the disease better with fewer side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 3 weeks, 1 month, and 4 months after the nk cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 3 weeks, 1 month, and 4 months after the nk cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Natural Killer (NK) Cells with Lenalidomide and Lymphodepleting Chemotherapy
Secondary outcome measures
Biopsy

Side effects data

From 2017 Phase 2 trial • 25 Patients • NCT01370213
96%
Chills
92%
Hypertension
76%
Fever
72%
Febrile Neutropenia
64%
Infusion Related Reaction
60%
Edema
56%
Hypoxia
56%
Dyspnea
56%
Rash
52%
Injection Site Reaction
20%
Pneumonitis/Pulmonary Infiltrates
12%
Back Pain
12%
Nausea
12%
Weight Gain
12%
Acute Kidney Injury
12%
Cytomegalovirus
12%
Headache
8%
Abdominal Pain
8%
Creatinine Increased
8%
Epigastric Pain
8%
Hypocellular Bone Marrow
8%
Hypotension
8%
Pneumonitis
8%
Respiratory Failure
8%
Sepsis
8%
Atrial Fibrillation
4%
Dyspepsia
4%
Maculo-Papular Rash
4%
Anorexia
4%
Acute Coronary Syndrome
4%
Foot Pain
4%
Gastrointestinal Bleeding
4%
Hemoptysis
4%
Infection, NOS
4%
Eye Irritation
4%
Urinary Frequency
4%
Lethargy
4%
Shoulder Pain
4%
Vivid Dreams
4%
Pustular Folliculitis, Scalp
4%
Sinus Tachycardia
4%
Skin Nodules
4%
Vomiting - Intermittent
4%
Erythema at Central Venous Catheter Site
4%
Eye Infection
4%
Facial, Jaw, Parotid Pain
4%
Leg Weakness
4%
Multi-Organ Failure
4%
Pericardial Effusion
4%
Disease Relapse
4%
Ankle Sprain
4%
Ascites
4%
Disseminated Intravascular Coagulation
4%
Encephalopathy
4%
Graft Failure
4%
Heart Failure
4%
Retrobulbar Optic Neuritis
4%
Upper Respiratory Infection
4%
Vision Changes, NOS
4%
Adult Respiratory Distress Syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-Risk Acute Myeloid Disease

Trial Design

3Treatment groups
Experimental Treatment
Group I: Lymphodepleting Chemotherapy Option #3Experimental Treatment4 Interventions
For myeloid malignancies Lenalidomide 2.5 mg by mouth once a day on Days -2 to Day +14. Fludarabine 30 mg/m2 by vein over 1 hour on Days -6 to -2. Cytarabine 2 mg/m2 by vein on Days -6 to -2. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.
Group II: Lymphodepleting Chemotherapy Option #2Experimental Treatment4 Interventions
For all malignancies if able to tolerate higher dose cyclophosphamide per the discretion of the treating physician Lenalidomide 2.5 mg by mouth once a day on Days -2 through Day +14. Fludarabine 25 mg/m2 by vein over 1 hour on Day -6 to -2. Cyclophosphamide 60 mg/kg by vein over 3 hours on Days -5 and -4. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.
Group III: Lymphodepleting Chemotherapy Option #1Experimental Treatment5 Interventions
Preferred regimen for CLL and low grade lymphoma Lenalidomide 2.5 mg by mouth once a day on Days -2 through Day +14. Fludarabine 25 mg/m2 by vein over 1 hour on Days -5 to -3. Cyclophosphamide 200 mg/m2 by vein over 3 hours on Days -5 to -3. Rituximab 375 mg/m2 by vein over 3-6 hours on Day -5 for participants with B-cell cancer. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NK Cells
2020
Completed Phase 2
~40
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,909 Total Patients Enrolled
451 Trials studying Leukemia
31,492 Patients Enrolled for Leukemia
The Leukemia and Lymphoma SocietyOTHER
81 Previous Clinical Trials
17,083 Total Patients Enrolled
41 Trials studying Leukemia
3,983 Patients Enrolled for Leukemia
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,227 Total Patients Enrolled
82 Trials studying Leukemia
2,681 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts currently underway for this clinical research?

"This trial is no longer recruiting subjects, having been initially posted on March 5th 2015 and most recently modified June 29th 2022. For those searching for possibilities in clinical trials with leukemia, there are currently 1412 studies open to applicants while 1480 studies related to NK Cells have openings."

Answered by AI

What afflictions can be remedied by utilizing natural killer cells?

"NK Cells are widely used to treat chronic lymphocytic leukemia, yet they can also be employed in the management of lung cancers and multiple sclerosis with at least two prior chemotherapy regimens."

Answered by AI

Is it possible for me to participate in this clinical experiment?

"This clinical trial is seeking 8 suitable candidates that have been diagnosed with leukemia and are aged between 18 and 80."

Answered by AI

Has the FDA sanctioned NK Cell therapies?

"The risk associated with NK Cells is relatively low due to the limited data supporting its efficacy, thus earning it a rating of 1."

Answered by AI

Has there been any historic research into the use of NK Cells?

"At present, there are 1480 ongoing trials for NK Cells with 292 of them in their final phase. Most studies are being conducted out of Mishawaka, Indiana but a total of 50299 sites across the country offer clinical trails involving these cells."

Answered by AI

Does this medical experiment accept seniors as participants?

"This medical trial is open to any applicant aged 18-80. There are 799 trials for minors, and 2329 studies available for geriatric patients."

Answered by AI

What is the enrollment size of this trial?

"Sadly, recruitment for this clinical trial is no longer being carried out. It was initially published on March 5th 2015 and the most recent update occurred June 29th 2022. Patients searching for similar studies can look into 1412 leukemia trials or 1480 investigations concerning NK Cells which are actively admitting participants at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma
2015. "Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02280525.
~1 spots leftby Apr 2025
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