LymphomaPhase 1NCT00383994
Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
A Phase 1 study testing GM-CSF, Rituximab and NK Cell Infusion in people with Lymphoma and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Leukemia, Transplantation, Stem Cell
- What is being tested?
- GM-CSF, Rituximab and NK Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to 22 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.
- Donor willingness to donate peripheral blood (same donor of the original transplant).
- Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.
Who cannot join
- Pregnancy or lactation
- HIV , HTLV-I or hepatitis.
- Active infection(s) >/= grade 3.
- Severe active concomitant medical or psychiatric illness.
- Concurrent active GVHD requiring tacrolimus.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation.
Primary Objectives:
Read more
1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.
2.0 To determine factors associated with response.
Read the detailed description
Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam. Your blood (about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have computerized tomography (CT) scans as well as positron emission tomography (PET) or gallium scans to learn the status of your disease. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found eligible to take part in this study, you will receive treatment as an outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the day before you receive the administration of rituximab. You will receive rituximab over 4 to 8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from the same donor from whom you received your original transplant. These cells will be infused through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are receiving a cell infusion from somebody who you are not related to, the infusion may have to be done later if cells were not available as scheduled.
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
During this treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
You may be taken off this study if your disease gets worse or intolerable side effects occur.
You will have long-term, follow-up visits while on study. You will be seen at 4 to 6 weeks after you receive NK cell infusion; every 3 months during the first year; and then once a year. During each of these visits, you will have CT and PET scans, a bone marrow biopsy, and blood drawn (about 4 teaspoons) to learn the status of your disease.
This is an investigational study. Rituximab and GM-CSF are FDA approved and commercially available. NK cells are authorized by the FDA for use in research only. Up to 40 participants will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
- Conditions
- Lymphoma, Leukemia, Transplantation, Stem Cell, Lymphoid Malignancies, Disorder Related to Transplantation
- Being tested
- GM-CSF, Rituximab, NK Cell Infusion
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Non-Hodgkin's Lymphoma, B-Cell Lymphoma, Lymphoma, granulocyte-macrophage colony-stimulating factor, Leukemia, NK Cells, Rituximab, GM-CSF, Non-myeloablative Allogeneic Stem Cell Transplantation, Stem Cell Transplant
- Medical subject headings
- Lymphoma, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Also called Sargramostim, Leukine
250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
RituximabDrug
Also called Rituxan
375 mg/m^2 by vein followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
NK Cell InfusionBiological
NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy with NK Cell, Rituximab + GM-CSF | Experimental | Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation
GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor Receives: Drug: GM-CSF; Drug: Rituximab; Biological: NK Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies
Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.
Measured: Evaluated for toxicity within 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383994
- Sponsor's protocol ID
- 2005-0234
- Other IDs
- NCI-2012-01375
- Status last verified
- Jul 2019
- First submitted
- 2 Oct 2006
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00383994
- Acronym / sponsor ID
- 2005-0234
- Conditions
- Lymphoma, Leukemia, Transplantation, Stem Cell, Lymphoid Malignancies, Disorder Related to Transplantation
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Non-Hodgkin's Lymphoma, B-Cell Lymphoma, Lymphoma, granulocyte-macrophage colony-stimulating factor, Leukemia, NK Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Sep 2006 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 4 Oct 2006 (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 goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation.
Primary Objectives:
1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.
2.0 To determine factors associated with response.
Detailed description
Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam. Your blood (about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have computerized tomography (CT) scans as well as positron emission tomography (PET) or gallium scans to learn the status of your disease. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found eligible to take part in this study, you will receive treatment as an outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the day before you receive the administration of rituximab. You will receive rituximab over 4 to 8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from the same donor from whom you received your original transplant. These cells will be infused through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are receiving a cell infusion from somebody who you are not related to, the infusion may have to be done later if cells were not available as scheduled.
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
During this treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
You may be taken off this study if your disease gets worse or intolerable side effects occur.
You will have long-term, follow-up visits while on study. You will be seen at 4 to 6 weeks after you receive NK cell infusion; every 3 months during the first year; and then once a year. During each of these visits, you will have CT and PET scans, a bone marrow biopsy, and blood drawn (about 4 teaspoons) to learn the status of your disease.
This is an investigational study. Rituximab and GM-CSF are FDA approved and commercially available. NK cells are authorized by the FDA for use in research only. Up to 40 participants will take part in this study. All will be enrolled at the University of Texas (UT) MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy with NK Cell, Rituximab + GM-CSF | Experimental | Drug: GM-CSF, Drug: Rituximab, Biological: NK Cell InfusionImmunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.
- Donor willingness to donate peripheral blood (same donor of the original transplant).
- Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- HIV , HTLV-I or hepatitis.
- Active infection(s) >/= grade 3.
- Severe active concomitant medical or psychiatric illness.
- Concurrent active GVHD requiring tacrolimus.
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 |
|---|---|---|
| GM-CSFAlso: Sargramostim, Leukine250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab. | Drug | Immunotherapy with NK Cell, Rituximab + GM-CSF |
| RituximabAlso: Rituxan375 mg/m^2 by vein followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses. | Drug | Immunotherapy with NK Cell, Rituximab + GM-CSF |
| NK Cell InfusionNK cells will be infused one week after the fourth dose of Rituximab and GM-CSF. | Biological | Immunotherapy with NK Cell, Rituximab + GM-CSF |
Primary outcome
Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies
Time frame: Evaluated for toxicity within 6 weeks of treatment
Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.
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 31 Jul 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Issa F. Khouri, MD principal investigator
M.D. Anderson Cancer 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 GM-CSF, Rituximab and NK Cell Infusion in people with Lymphoma and Leukemia, run by M.D. Anderson Cancer 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 3 inclusion and 5 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 31 Jul 2019. 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?
Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies (time frame: Evaluated for toxicity within 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2019.