LeukemiaPhase 1NCT00477035
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies
A Phase 1 study testing CIK cells, etoposide and bcnu in people with Leukemia and Multiple Myeloma, run by Sally Arai at 1 site in United States.
Trial summary
The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Leukemia, Multiple Myeloma
- What is being tested?
- CIK cells, etoposide and bcnu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 75 years of age, inclusive candidates for standard autologous SCT who are at high risk for relapse:
- Acute myelogenous leukemia (AML), high risk, in CR1 or beyond without a donor (CR1 defined as: normal bone marrow morphology, resolution of any previously abnormal karyotype, neutrophils > 1000/ul, platelets > 100,000/ul, independence from red cell transfusion, no evidence extramedullary leukemia)
- Hodgkin's lymphoma relapsed or refractory, with the presence of >= 1 adverse risk factor (Adverse risk factors are defined as stage IV involvement of the lung or bone marrow, constitutional symptoms, and the presence of more than minimal residual disease before the preparatory regimen)
- Multiple myeloma with high risk features with only single autologous transplant option. High risk features defined as IgA myeloma, B2M > 2.5 mg/ml with normal kidney function, complex karyotypes or isolated chromosome 13 abnormalities, standard-dose therapy > 12 months, or inability to achieve at least 50% reduction of plasma cells in the bone marrow or 50% reduction in the paraprotein concentration after initial induction chemotherapy prior to transplant.
- Patients must have ECOG performance status < 2
- Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or creatinine clearance > 50 ml/min.
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- Patients must have adequate liver function with a total bilirubin < 2 mg/dl or transaminases < 3 times the upper limit of normal.
- Patients must have negative antibody serology for human immunodeficiency virus (HIV1 and 2)
- Adult women and minorities will be included. Patients with childbearing potential must use effective contraception.
- Patients must sign informed consent prior to initiation of any study-related treatments.
Who cannot join
- ECOG performance status > 2
- LVEF < 45%
- Pulmonary diffusion capacity < 50% predicted
- Total bilirubin > 2 mg/dl
- Creatinine > 2 mg/dl
- Pregnancy
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- Patients positive for HIV
- Patients with engraftment failure at day 42 post transplant defined as failure to achieve a granulocyte count > 500/ul on 3 successive daily determinations and an unsupported platelet count of >= 50,000/ul by day 42
- Patients with active, uncontrolled infection that is expected to continue beyond day 42-63.
- Patients who fail to collect sufficient quantities of stem cells (> 1.6 x 10^9 cells) during apheresis to support CIK cell expansion cultures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies
The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.
Read the detailed description
Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.
- Conditions
- Leukemia, Multiple Myeloma
- Being tested
- CIK cells, etoposide, bcnu, cyclophosphamide, gemcitabine
- Medical subject headings
- Leukemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIK cellsDrug
Also called autologous cytokine-induced killer cells
2x10e8 cells/kg
etoposideDrug
Also called Eposin, Etopophos, Vepesid, VP-16
60 mg/kg
bcnuDrug
Also called Carmustine
15 mg/kg
cyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
100 mg/kg
gemcitabineDrug
Also called Gemzar
1250 mg/m2
vinorelbineDrug
Also called Navelbine
30 mg/m2
melphalanDrug
Also called Alkeran, Melphalan hydrochloride
200 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Autologous Cytokine-induced Killer Cells | Experimental | Not described Receives: Drug: CIK cells; Drug: etoposide; Drug: bcnu; Drug: cyclophosphamide; Drug: gemcitabine; Drug: vinorelbine; Drug: melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the toxicities of infusion of autologous CIK cells
Measured: Day 42 post autologous stem cell transplant
Measure freedom from progression (FFP)
Measured: 1 and 2 years post-transplant
Measure event free survival
Measured: 1 and 2 years post-transplant
Measure overall survival
Measured: 1 and 2 years post-transplant
Secondary outcomes (1)
Measure disease response
Measured: at day 40-60, day 90, day 180, and yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sally Arai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally Arai, Stanford University
- Investigators
- Sally Arai, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477035
- Sponsor's protocol ID
- IRB-00245
- Other IDs
- 95889, BMT173
- Status last verified
- Jan 2017
- First submitted
- 18 May 2007
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00477035
- Acronym / sponsor ID
- IRB-00245
- Conditions
- Leukemia, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sally AraiUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 May 2007 (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 the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.
Detailed description
Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Cytokine-induced Killer Cells | Experimental | Drug: CIK cells, Drug: etoposide, Drug: bcnu, Drug: cyclophosphamide, Drug: gemcitabine, Drug: vinorelbine, Drug: melphalan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients between 18 and 75 years of age, inclusive candidates for standard autologous SCT who are at high risk for relapse:
- Patients must have ECOG performance status < 2
- Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or creatinine clearance > 50 ml/min.
- Patients must have adequate liver function with a total bilirubin < 2 mg/dl or transaminases < 3 times the upper limit of normal.
- Patients must have negative antibody serology for human immunodeficiency virus (HIV1 and 2)
Key exclusion criteria (10 listed)
- ECOG performance status > 2
- LVEF < 45%
- Pulmonary diffusion capacity < 50% predicted
- Total bilirubin > 2 mg/dl
- Creatinine > 2 mg/dl
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 |
|---|---|---|
| CIK cellsAlso: autologous cytokine-induced killer cells2x10e8 cells/kg | Drug | Autologous Cytokine-induced Killer Cells |
| etoposideAlso: Eposin, Etopophos, Vepesid, VP-1660 mg/kg | Drug | Autologous Cytokine-induced Killer Cells |
| bcnuAlso: Carmustine15 mg/kg | Drug | Autologous Cytokine-induced Killer Cells |
| cyclophosphamideAlso: Endoxan, Cytoxan, Neosar, Procytox100 mg/kg | Drug | Autologous Cytokine-induced Killer Cells |
| gemcitabineAlso: Gemzar1250 mg/m2 | Drug | Autologous Cytokine-induced Killer Cells |
| vinorelbineAlso: Navelbine30 mg/m2 | Drug | Autologous Cytokine-induced Killer Cells |
| melphalanAlso: Alkeran, Melphalan hydrochloride200 mg/m2 | Drug | Autologous Cytokine-induced Killer Cells |
Primary outcome
To document the toxicities of infusion of autologous CIK cells
Time frame: Day 42 post autologous stem cell transplant
Measure freedom from progression (FFP)
Time frame: 1 and 2 years post-transplant
Measure event free survival
Time frame: 1 and 2 years post-transplant
Measure overall survival
Time frame: 1 and 2 years post-transplant
1 secondary outcome
Measure disease response
Time frame: at day 40-60, day 90, day 180, and yearly
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 11 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Sally Arai principal investigator
Stanford University
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 CIK cells, etoposide and bcnu in people with Leukemia and Multiple Myeloma, run by Sally Arai 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 10 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 11 Jan 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 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?
To document the toxicities of infusion of autologous CIK cells (time frame: Day 42 post autologous stem cell transplant). The study lists 4 primary outcomes in all. 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 11 Jan 2017.