LymphomaPhase 1NCT00660166
Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
A Phase 1 study testing NK-Cell Infusion in people with Lymphoma and Myeloma, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- What is being tested?
- NK-Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone an autologous stem cell transplant for the following diseases:
- Acute Myeloid Leukemia
- Non-Hodgkin's Lymphoma
- Hodgkin's Disease
- Multiple Myeloma
- Age 13 - 70 years old
Show all 10Show fewer
- Able to give informed consent
- Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
- ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
- Patients with no active infection
Who cannot join
- Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have > grade 2 toxicity in any organ system)
- Patients who have insufficient engraftment parameters according to the following criteria: WBC < 2,500 /mm3 and platelets < 50,000/mm3
- Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
- Intrinsic impaired organ function (as stated above).
- Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
- Uncontrolled, life-threatening infections at the time of infusion.
- Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.
Read the detailed description
Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.
- Being tested
- NK-Cell Infusion
- Keywords
- Natural killer cells, autologous stem cell transplant, immunotherapy
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK-Cell InfusionBiological
The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: NK-Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety.
Measured: 58 days post infusion of allogeneic NK-cells
Secondary outcomes (5)
Duration of donor NK cells in the recipient's blood
Measured: 58 days post infusion of allogeneic NK-cells
Patient survival at 100 days and at one year post treatment (all cause mortality)
Measured: 100 days and one year post treatment
Occurrence of new cancer during the first year post infusion of allogeneic NK-cells
Measured: One year post infusion of allogeneic NK-cells
Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells.
Measured: 30 days post infusion of allogeneic NK-cells
Occurrence of other possible NK-infusions related complications such as,fever, capillary leak syndrome and/or allergic reaction.
Measured: 58 days post infusion of allogeneic NK-cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Hans Klingemann, MD, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660166
- Sponsor's protocol ID
- Allogeneic NKCell post ABMT
- Status last verified
- Jun 2012
- First submitted
- 11 Apr 2008
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klingemann H, Boissel L. Targeted cellular therapy with natural killer cells. Horm Metab Res. 2008 Feb;40(2):122-5. doi: 10.1055/s-2007-1004576.
PubMed 18283630Klingemann HG. Natural killer cell-based immunotherapeutic strategies. Cytotherapy. 2005;7(1):16-22. doi: 10.1080/14653240510018000.
PubMed 16040380
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00660166
- Acronym / sponsor ID
- Allogeneic NKCell post ABMT
- Keywords
- Natural killer cells, autologous stem cell transplant, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Apr 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.
Detailed description
Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: NK-Cell Infusion |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who have undergone an autologous stem cell transplant for the following diseases:
- Age 13 - 70 years old
- Able to give informed consent
- Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
- ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
Key exclusion criteria (7 listed)
- Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have > grade 2 toxicity in any organ system)
- Patients who have insufficient engraftment parameters according to the following criteria: WBC < 2,500 /mm3 and platelets < 50,000/mm3
- Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
- Intrinsic impaired organ function (as stated above).
- Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK-Cell InfusionThe infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight. | Biological | 1 |
Primary outcome
An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety.
Time frame: 58 days post infusion of allogeneic NK-cells
5 secondary outcomes
Duration of donor NK cells in the recipient's blood
Time frame: 58 days post infusion of allogeneic NK-cells
Patient survival at 100 days and at one year post treatment (all cause mortality)
Time frame: 100 days and one year post treatment
Occurrence of new cancer during the first year post infusion of allogeneic NK-cells
Time frame: One year post infusion of allogeneic NK-cells
Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells.
Time frame: 30 days post infusion of allogeneic NK-cells
Occurrence of other possible NK-infusions related complications such as,fever, capillary leak syndrome and/or allergic reaction.
Time frame: 58 days post infusion of allogeneic NK-cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- Results publication: PubMed 18283630Klingemann H, Boissel L. Targeted cellular therapy with natural killer cells. Horm Metab Res. 2008 Feb;40(2):122-5. doi: 10.1055/s-2007-1004576.
- Results publication: PubMed 16040380Klingemann HG. Natural killer cell-based immunotherapeutic strategies. Cytotherapy. 2005;7(1):16-22. doi: 10.1080/14653240510018000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Klingemann, MD, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK-Cell Infusion in people with Lymphoma and Myeloma, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety. (time frame: 58 days post infusion of allogeneic NK-cells). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.