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Natural Killer Cell Therapy
Treatment Plan 2 (NK cells, umbilical cord blood transplant) for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Chitra Hosing
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 1 year
Awards & highlights
Summary
This trial is testing side effects and best way to give natural killer cells and donor umbilical cord blood transplant to treat patients with cancer.
Eligible Conditions
- Non-Hodgkin's Lymphoma
- Chronic Lymphocytic Leukemia
- Multiple Myeloma
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Biphenotypic Leukemia
- Hodgkin's Lymphoma
- Chronic Myelogenous Leukemia
- B-Cell Lymphoma
- Acute Lymphoblastic Leukemia
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Generation of a minimum of 5 x 10^6 natural killer/kg cells in at least 60% of patients (success rate)
Incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Treatment-related mortality
Secondary study objectives
Disease-free survival
Overall survival
Time to initial absolute neutrophil count recovery
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Plan 2 (NK cells, umbilical cord blood transplant)Experimental Treatment11 Interventions
Patients receive high-dose lenalidomide PO QD on days -7 to -2, cyclophosphamide IV over 3 hours on day -7, and undergo TBI on day -3. Patients also receive rituximab and fludarabine phosphate as in Treatment Plan 1.
Group II: Treatment Plan 1 (NK cells, umbilical cord blood transplant)Experimental Treatment10 Interventions
Patients receive high-dose lenalidomide PO QD on days -8 to -2, fludarabine phosphate IV over 1 hour on days -7 to -4, and melphalan IV over 30 minutes on day -4. CD20 positive patients also receive rituximab IV over 6 hours on days -8 to -4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Mechlorethamine
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1180
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Cyclophosphamide
FDA approved
Tacrolimus
FDA approved
Rituximab
FDA approved
Mycophenolate mofetil
FDA approved
Lenalidomide
FDA approved
Natural Killer Cell
Not yet FDA approved
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,688 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,987 Total Patients Enrolled
Chitra HosingPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
27 Total Patients Enrolled
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