LeukemiaPhase 1/2NCT00625729
Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1/2 study testing aldesleukin, allogeneic natural killer cells and rituximab in people with Leukemia and Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- aldesleukin, allogeneic natural killer cells and rituximab
- 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
- Jan 2008to Apr 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years or older with a diagnosis of non-Hodgkin Lymphoma or chronic lymphocytic leukemia (NHL or CLL) and one of the following:
- Progression of NHL following at least 2 prior chemotherapy regimens, (must contain rituximab for all NHL and fludarabine for follicular NHL) defined as:
- failure to achieve partial remission (PR) with the last chemotherapy
- disease progression within 6 months following last chemotherapy
- Progression of CLL/SLL (small lymphocytic lymphoma) following at least 2 prior chemotherapy regimens (containing purine analogs ) in stage Rai III or IV or symptomatic disease.
- Relapsed NHL or CLL following stem cell transplantation for whom the option of donor lymphocyte infusion is not available or clinically indicated (e.g. recipients of autologous or umbilical cord blood [UCB] transplants).
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- Available related HLA-haploidentical (human leukocyte antigen) natural killer (NK) cell adult donor by at least Class I serologic typing
- Karnofsky performance status > 60%
- Measurable disease based on modified Response Evaluation Criteria In Solid Tumors (RECIST)
- Have acceptable organ function as defined within 28 days of enrollment:
- Hematologic: platelets ≥ 80,000 x 10^9/L; hemoglobin ≥ 9g/dL, unsupported by transfusions; absolute neutrophil count (ANC) ≥ 1000 x 10^9/L, unsupported by granulocyte-colony stimulating factor or granulocyte-macrophage colony-stimulating factor (G-CSF or GM-CS)F for 10 days or Neulasta for 21 days - the hematologic requirements are waived for patients with inadequate counts due to known bone marrow involvement by lymphoma who are otherwise eligible
- Renal: glomerular filtration rate (GFR) > 50 ml/min
- Hepatic: alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 3 x upper limit of normal and total bilirubin <3 mg/dl
- Pulmonary function: >50% corrected carbon monoxide diffusing capacity (DLCO) and Forced Expiratory Volume in the first second (FEV1)
- Cardiac: no symptoms of uncontrolled cardiac disease, left ventricular ejection fraction >40%
- Off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0
- Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Who cannot join
- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing age must use appropriate contraceptive method.
- Active central nervous system (CNS) lymphoma/leukemia
- Active serious infection (pulmonary infiltrates or lesions are allowed only after the appropriate diagnostic testing is negative for infection or appropriate therapy was initiated for probable infection)
- Pleural effusion - large enough to be detectable on the chest x-ray
- Allergy to rituximab or IL-2
- Human immunodeficiency virus (HIV) and associated non-Hodgkins lymphoma (NHL)
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- Active concurrent malignancy (except skin cancer) requiring systemic therapy in the past 2 years
- Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder
- Positive hepatitis B surface antigen (HBsAg). If Hepatitis B core antibody (HBcAb) is positive, Hepatitis B deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) will be evaluated. Positive anti HBcAb and undetectable viral load does not exclude the patient.
- Any experimental therapy in the past 30 days
- Donor Selection:
- Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling) ≥ age 18 years
- Able and willing to undergo lymphapheresis
- HLA-haploidentical donor/recipient match. If time permits and multiple donors are available, preference will be given to the Killer-cell Immunoglobulin-like Receptors (KIR) ligand mismatched donor (as predicted by HLA typing).
- HIV-1, HIV-2 negative, Human T-lymphotropic virus Type I (HTLV-1), HTLV-2 negative, West Nile virus (WNV) negative, Hepatitis B and C negative
- Adequate organ function defined as:
- Hematologic: CBC/diff/platelet count near normal limits,
- Hepatic: ALT < 2 x upper limit of normal,
- Not pregnant or lactating
- In general good health as determined by the study physician
- Able to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: MT2007-12 Allogeneic Natural Killer Cells With Rituximab in Patients With CD20 Positive Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. Strategies to Increase Sensitivity of CLL Tumor Cells to Natural Killer Cell-Immune-Mediated Cytolysis
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells.
PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy followed by a donor natural killer cell infusion that has been treated in the laboratory with aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- To determine if allogeneic natural killer (NK) cells infused following chemoimmunotherapy can be safely expanded in vivo with aldesleukin.
Secondary
- To determine if interleukin-15 production at day 0 correlates with NK cells expansion.
- To determine overall response rate at 3 months.
- To determine time to progression and overall survival.
- To characterize the quantitative and qualitative toxicities of this treatment plan.
- To determine the incidence of donor products that do not meet release criteria and the NK cell numbers infused.
- To correlate clinical response with donor/recipient KIR ligand matching status, FcG receptor 3A genotype, and NK cells phenotype and function
- To determine pharmacodynamic and pharmacogenomic markers and correlate them with NK cell expansion and disease response.
OUTLINE:
- Conditioning regimen: Patients receive rituximab intravenously (IV) over 6-8 hours on days -8, -1, 6, and 13; fludarabine IV on days -6 to -2; and cyclophosphamide IV on day -5.
- Allogeneic natural killer (NK) cell administration: Patients receive aldesleukin-activated haploidentical NK cells IV over less than 1 hour on day 0. Within 4 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses. Patients also receive filgrastim (G-CSF) SC beginning on day 14 and continuing until absolute neutrophil count (ANC) is > 2,500/mm³ for 2 consecutive days.
Patients who achieve a complete or partial response at 28 days are eligible for allogeneic stem cell transplantation. Patients who achieve initial response at 3 months, clinically benefit from treatment, but subsequently relapse are eligible for retreatment provided all eligibility criteria are met.
Blood samples are collected periodically for correlative laboratory studies. Patients with chronic lymphocytic leukemia (CLL) also undergo bone marrow aspiration periodically for correlative laboratory studies.
After completion of study treatment, patients are followed periodically for up to 1 year.
- Being tested
- aldesleukin, allogeneic natural killer cells, rituximab, cyclophosphamide, fludarabine phosphate
- Keywords
- recurrent adult grade III lymphomatoid granulomatosis, adult nasal type extranodal NK/T-cell lymphoma, Waldenstrom macroglobulinemia, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Lymphoma, Lymphoma, Extranodal NK-T-Cell, Waldenstrom Macroglobulinemia, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Also called IL-2
Day 0-14, 10 million international units, 3 times per week for 6 doses
allogeneic natural killer cellsBiological
Also called Natural Killer Cells
Day 0 infusion of cells (1.5-8 x 10^7 cells/kg).
rituximabBiological
Also called Rituxan
Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m^2
cyclophosphamideDrug
Also called Cytoxan
60 mg/kg intravenous (IV) on Day -5.
Also called Fludara
Day -6 through day -2, 25 mg/m^2 intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Treated Patients | Experimental | Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy. Receives: Biological: aldesleukin; Biological: allogeneic natural killer cells; Biological: rituximab; Drug: cyclophosphamide; Drug: fludarabine phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Exhibiting Natural Killer Cell Expansion
Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.
Measured: Day 14
Secondary outcomes (5)
Number of Patients With Interleukin-15 Production and NK Cell Expansion
Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion
Measured: Day 0
Number of Patients With Overall Response
Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia
Measured: 3 Months
Number of Patients Whose Disease Progressed After Treatment
Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.
Measured: 6 Months
Number of Patients With Adequate Natural Killer Cells Infused
Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).
Measured: Day 0
Number of Patients With Overall Survival
Number of patients alive at 6 months after treatment.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionApr 2010
Why it stopped: No patients exhibited natural killer cell expansion (primary endpoint).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Veronika Bachanova, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625729
- Sponsor's protocol ID
- 2007LS064
- Other IDs
- MT2007-12, UMN-0707M13561, P01CA065493
- Status last verified
- Dec 2017
- First submitted
- 26 Feb 2008
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2007-12 Allogeneic Natural Killer Cells With Rituximab in Patients With CD20 Positive Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. Strategies to Increase Sensitivity of CLL Tumor Cells to Natural Killer Cell-Immune-Mediated Cytolysis
- ClinicalTrials.gov ID
- NCT00625729
- Acronym / sponsor ID
- 2007LS064
- Keywords
- recurrent adult grade III lymphomatoid granulomatosis, adult nasal type extranodal NK/T-cell lymphoma, Waldenstrom macroglobulinemia, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients exhibited natural killer cell expansion (primary endpoint).
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 30 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells.
PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy followed by a donor natural killer cell infusion that has been treated in the laboratory with aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
Primary
- To determine if allogeneic natural killer (NK) cells infused following chemoimmunotherapy can be safely expanded in vivo with aldesleukin.
Secondary
- To determine if interleukin-15 production at day 0 correlates with NK cells expansion.
- To determine overall response rate at 3 months.
- To determine time to progression and overall survival.
- To characterize the quantitative and qualitative toxicities of this treatment plan.
- To determine the incidence of donor products that do not meet release criteria and the NK cell numbers infused.
- To correlate clinical response with donor/recipient KIR ligand matching status, FcG receptor 3A genotype, and NK cells phenotype and function
- To determine pharmacodynamic and pharmacogenomic markers and correlate them with NK cell expansion and disease response.
OUTLINE:
- Conditioning regimen: Patients receive rituximab intravenously (IV) over 6-8 hours on days -8, -1, 6, and 13; fludarabine IV on days -6 to -2; and cyclophosphamide IV on day -5.
- Allogeneic natural killer (NK) cell administration: Patients receive aldesleukin-activated haploidentical NK cells IV over less than 1 hour on day 0. Within 4 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses. Patients also receive filgrastim (G-CSF) SC beginning on day 14 and continuing until absolute neutrophil count (ANC) is > 2,500/mm³ for 2 consecutive days.
Patients who achieve a complete or partial response at 28 days are eligible for allogeneic stem cell transplantation. Patients who achieve initial response at 3 months, clinically benefit from treatment, but subsequently relapse are eligible for retreatment provided all eligibility criteria are met.
Blood samples are collected periodically for correlative laboratory studies. Patients with chronic lymphocytic leukemia (CLL) also undergo bone marrow aspiration periodically for correlative laboratory studies.
After completion of study treatment, patients are followed periodically for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Patients | Experimental | Biological: aldesleukin, Biological: allogeneic natural killer cells, Biological: rituximab, Drug: cyclophosphamide, Drug: fludarabine phosphatePatients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient 18 years or older with a diagnosis of non-Hodgkin Lymphoma or chronic lymphocytic leukemia (NHL or CLL) and one of the following:
- Available related HLA-haploidentical (human leukocyte antigen) natural killer (NK) cell adult donor by at least Class I serologic typing
- Karnofsky performance status > 60%
- Measurable disease based on modified Response Evaluation Criteria In Solid Tumors (RECIST)
- Have acceptable organ function as defined within 28 days of enrollment:
Key exclusion criteria (21 listed)
- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing age must use appropriate contraceptive method.
- Active central nervous system (CNS) lymphoma/leukemia
- Active serious infection (pulmonary infiltrates or lesions are allowed only after the appropriate diagnostic testing is negative for infection or appropriate therapy was initiated for probable infection)
- Pleural effusion - large enough to be detectable on the chest x-ray
- Allergy to rituximab or IL-2
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 |
|---|---|---|
| aldesleukinAlso: IL-2Day 0-14, 10 million international units, 3 times per week for 6 doses | Biological | Treated Patients |
| allogeneic natural killer cellsAlso: Natural Killer CellsDay 0 infusion of cells (1.5-8 x 10^7 cells/kg). | Biological | Treated Patients |
| rituximabAlso: RituxanAdministered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m^2 | Biological | Treated Patients |
| cyclophosphamideAlso: Cytoxan60 mg/kg intravenous (IV) on Day -5. | Drug | Treated Patients |
| fludarabine phosphateAlso: FludaraDay -6 through day -2, 25 mg/m^2 intravenous (IV) | Drug | Treated Patients |
Primary outcome
Number of Patients Exhibiting Natural Killer Cell Expansion
Time frame: Day 14
Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.
5 secondary outcomes
Number of Patients With Interleukin-15 Production and NK Cell Expansion
Time frame: Day 0
Number of Patients With Overall Response
Time frame: 3 Months
Number of Patients Whose Disease Progressed After Treatment
Time frame: 6 Months
Number of Patients With Adequate Natural Killer Cells Infused
Time frame: Day 0
Number of Patients With Overall Survival
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Veronika Bachanova, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aldesleukin, allogeneic natural killer cells and rituximab in people with Leukemia and Lymphoma, run by Masonic Cancer Center, University of Minnesota 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 18 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Dec 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Exhibiting Natural Killer Cell Expansion (time frame: Day 14). 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 28 Dec 2017.