Natural Killer (NK) Cells in Cord Blood Transplantation
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|ClinicalTrials.gov Identifier: NCT01619761|
Recruitment Status : Recruiting
First Posted : June 14, 2012
Last Update Posted : January 28, 2019
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if giving cells called natural killer (NK) cells after receiving a chemotherapy treatment and a UCB transplant can improve response in patients with leukemia, lymphoma, or MM. The safety of this treatment and whether NK cells can lessen the risk of graft vs. host disease (GVHD) will also be studied.
Patients with a disease that is CD20-positive will also receive rituximab on this study.
The first 3 patients enrolled on this study will not receive NK cells but will receive a cord blood transplant.
UCB and NK cells may be able to kill leukemia, lymphoma, or myeloma cells that remain in your body after chemotherapy treatment.
The UCB cells are also designed to increase blood production and strengthen your immune system.
This is an investigational study. Cyclophosphamide, fludarabine, melphalan, lenalidomide, and the UCB transplant procedure are all FDA approved and commercially available for the treatment of CLL. Cyclophosphamide is approved for the treatment of CLL. Fludarabine is approved for treatment of refractory CLL. Melphalan is approved for the treatment of multiple myeloma (MM) but has been used in transplant conditioning regimens. Lenalidomide is approved for the treatment of low risk myelodysplastic syndromes and for MM. Rituximab is approved for the treatment of CD20 positive B-cell lymphomas and chronic lymphocytic leukemia (in combination with chemotherapy).
The use of NK cells in patients is investigational.
Up to 13 participants will be enrolled in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Chronic Lymphocytic Leukemia||Drug: Lenalidomide Drug: Fludarabine monophosphate Drug: Melphalan Procedure: NK Infusion Procedure: CB Infusion Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Rituximab Drug: Cyclophosphamide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Killer Cells In Allogeneic Cord Blood Transplantation|
|Actual Study Start Date :||May 3, 2013|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: CB NK + Chemotherapy
Lenalidomide 10 mg by mouth day -8 to -2. Fludarabine 40 mg/m2 intravenous (IV) from day -7 to -4. Melphalan 140 mg/m2 IV on day -4. The NK cell infusion administered intravenously on day -2 over a period of 30 minutes. The NK dose infused will be 5x 10^6/kg. Remaining cells discarded if not needed for laboratory studies. On Day 0, unmanipulated products (smaller cord blood unit and remnant of the larger unit) infused. Tacrolimus 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no GvHD is present. Mycophenolate mofetil 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth Days -3 to Day +100 in the absence of GvHD.
CD20 positive participants admitted to hospital on day -9 to start hydration, receive rituximab 375 mg/m2 by vein on day -8, receive the designated preparative regimen on days -8 through -4. CD20 negative participants will not receive rituximab and admitted on day -8.
Treatment Plan #1: 10 mg by mouth on days -8 to -2.
Treatment Plan #2: 10 mg by mouth on days -7 to -2.
Drug: Fludarabine monophosphate
Treatment Plan #1 + #2: 40 mg/m2 by vein on days -7 to -4.
Treatment Plan #1: 140 mg/m2 by vein on day -4.
Other Name: Alkeran
Procedure: NK Infusion
Treatment Plan #1 + #2: The NK cell infusion administered intravenously on day -2 over a period of 30 minutes. The NK dose infused will be 5x 10^6/kg. Remaining cells will be discarded if not needed for laboratory studies.
Procedure: CB Infusion
Treatment Plan #1 + #2: On Day 0, the unmanipulated products (smaller cord blood unit and the remnant of the larger unit) will be infused.
Treatment Plan #1 + #2: 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no GvHD is present.
Other Name: Prograf
Drug: Mycophenolate mofetil
Treatment Plan #1 + #2: 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth Days -3 to Day +100 in the absence of GvHD.
375 mg/m2 by vein on day -8 for CD20 positive participants.
Other Name: Rituxan
Treatment Plan #2: 50 mg by vein on Day -7.
- Success Rate [ Time Frame: 3 months ]Success is ability to generate adequate NK cells in a patient (a minimum of 3x10e8 natural killer (NK) cells). Success Rate is number of participants achieving success divided by total participants.
- Treatment-Related Mortality (TRM) [ Time Frame: 100 days ]100-day treatment-related mortality (TRM) following the methods described by Thall et al.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619761
|Contact: Chitra M. Hosing, MD||713-792-8750|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra M. Hosing, MD||M.D. Anderson Cancer Center|