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Natural Killer Cell Therapy
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
Phase 1 & 2
Waitlist Available
Led By Richard E Champlin
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial uses special cells from donors to treat patients with severe blood cancers. Medicine is used first to eliminate cancer cells and prepare the body. The donor cells help rebuild the patient's blood and immune system to fight cancer.
Eligible Conditions
- Acute Myeloid Leukemia
- Erythroleukemia
- Myelodysplastic Syndrome
- Chronic Myelogenous Leukemia
- Aplastic Anemia
- Acute Leukemia
- Megakaryoblastic Leukemia
- Chronic Myelomonocytic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
Secondary study objectives
Number of Participants With Grade 3 Toxicities
Overall Survival
Side effects data
From 2022 Phase 1 & 2 trial • 63 Patients • NCT01823198100%
Mucositis
100%
Nausea
67%
Fluid overload
67%
Viral Infections
50%
Neutropenic fevers
50%
Skin GvHD
33%
Bacterial Infections
33%
Chronic ocular GvHD
33%
Chronic Skin GvHD
33%
Diarrhea
33%
Elevated transminitis
33%
Upper GI GvHD
17%
Chronic oral GvHD
17%
Chronic Liver GvHD
17%
Creatinine increased
17%
Elevated bilirubin
17%
Flu like syndrome
17%
Headache
17%
Pleural Effusion
17%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: NK Cell Dose Level 1_10^6
Phase I: NK Cell Dose Level 2_10^7
Phase I: NK Cell Dose Level 3_ 3x10^7
Phase I: NK Cell Dose Level 4_ 10^8
Phase II: NK Cell Dose Level 3_3x10^7
Donors
Phase II: NK Cell Dose Level 4_ 10^8
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (NK cells, PBSC transplant)Experimental Treatment8 Interventions
Patients receive fludarabine phosphate IV over 1 hour and busulfan IV over 3 hours on days -13 to -10. Patients then receive allogeneic CD56-positive CD3-negative natural killer cells IV over 1 hour on day -8. Patients also receive aldesleukin SC QD on days -8 to -4. Patients then undergo allogeneic PBSC transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic CD56-positive CD3-negative Natural Killer Cells
2013
Completed Phase 2
~70
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Aldesleukin
2012
Completed Phase 4
~1610
Busulfan
2008
Completed Phase 4
~1710
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,482 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,517 Total Patients Enrolled
Richard E ChamplinPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled