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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Disease-free survival
Overall survival
Proportion of patients with acute graft-versus-host-disease
+3 more

Trial 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
~1200
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
2,967 Previous Clinical Trials
1,804,789 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,654 Total Patients Enrolled
Chitra HosingPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
NK Cells in Cord Blood Transplantation
2013. "NK Cells in Cord Blood Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01619761.
All > Lenalidomide > Revlimid
~1 spots leftby Apr 2025
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