Acute Myeloid LeukemiaPhase 1/2alloCIKNCT00460694
Allogeneic Cytokine-induced Killer Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies
A Phase 1/2 study testing infusion of allogeneic CIK cells in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in patients undergoing mobilization for… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- infusion of allogeneic CIK cells
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2006to Dec 2012
- Phase
- Phase 1/2
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- This trial includes only patients who have relapsed after an allogeneic transplant, who have either:
- No response to conventional DLI given for at least one dose, or
- No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant
- Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.
- In view of the period taken to culture the cell to maturity, patient must have a life expectancy of more than one month. Interim measures eg chemotherapy or conventional DLI will be given during the interval so that ongoing treatment will not be compromised in any way.
Who cannot join
- Uncontrolled infection or significant bleeding
- Unstable vital signs
- Any degree of hypoxia requiring oxygen therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial on Allogeneic Cytokine-induced Killer Cell Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies
Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in patients undergoing mobilization for autologous transplant.
Donor lymphocyte infusion (DLI) has been shown to be active against some haematological malignancies including CML, AML, MDS,NHL and Hodgkin's disease. These donor lymphocytes can be further activated in vitro to become CIK cells. At least 2 other centers in the world have given allogeneic CIK cells for patients relapsing post allogeneic transplant for a variety of haematological malignancies. These early reports have demonstrated feasibility, absence of increased GVHD and possible efficacy in some cases.
Read more
We are proposing a Phase I /II study on the feasibility / efficacy of immunotherapy with allogeneic CIK cells for patients who relapse after allogeneic marrow transplant for their haematological malignancies. These patients have to be either refractory to conventional donor lymphocyte infusion, or need a larger number of donor lymphocyte than could be provided by unmanipulated donor lymphocytes. Donor lymphocytes will be collected and cultured in GMP facilities to maturity, then infused into patients. This will be given in graded doses at 4 weekly intervals and continued on in the absence of GVHD till remission is achieved or disease progression occurs. Patients may receive various forms of chemotherapy appropriate to the clinical condition in each case before the allogeneic CIK infusion.
Efficacy will be assessed by comparing the response to allogeneic CIK infusion vs that to due to conventional DLI, ie response to the two different treatment using DLI response as the comparator. We expect about 10 such cases to be done over the next 3 years. Significant statistics is unlikely to be generated but observation and description of the response can generate useful information for presence or not of the efficacy of such a treatment.
If clinical efficacy and superiority over conventional DLI is demonstrated, then future allogeneic CIK may take the place of DLI in this group of poor prognosis patients who relapse after allogeneic transplant .
Read the detailed description
- Patient inclusion criteria This trial includes only patients who have relapsed after an allogeneic transplant, who have either 1.1 No response to conventional DLI given for at least one dose, or 1.2 No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant 1,3 Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.
- Collection of peripheral blood stem cells ( PBSC ) Sibling allogeneic donors will routinely have their PBSC harvested for the purpose of infusion into the recipients. Currently our practice involves one additional day of collection to freeze as backup to be used for DLI in the event of relapse. This collection is frozen in a few aliquots, and is available for CIK culture when need arises For cord blood transplant, one issue is that DLI is not available. There is one report on growing CIK from residual cells in the bags of cord blood after infusion, then stored frozen for use in future if need arises. This does not in anyway compromise the cord blood infusion. Similarly this can be done in the case of unrelated donor transplant. This will serve as a backup in the event that donor is not available for repeat collection of lymphocyte.
- Culture of CIK cells
For culture from frozen product, this is rapidly thawed and culture started in gas permeable bags in complete medium and cytokine as detailed in SOP attached ( appendix 1 ). Culture medium and cytokine are added periodically till maturation of CIK at between 21-28 days.
For culture from residual cells in the thawed cord blood infusion bags, cells may need to undergo ficoll to remove rbc, then start culture in the similar way
- Harvesting of CIK cells
At maturity between D21-D28, all bags of CIK cells are pooled and washed using COBE 2991 cell harvester. This will ensure removal of >99.9% of the original culture medium. Cells are then frozen and aliquots sent for quality control to ensure compliance to GMP standard. This includes bacteriological and fungal culture, mycoplasma and endotoxin testing.
- Infusion of CIK cells Patients may undergo cytoreductive chemotherapy or oral immunosuppressive therapy as deemed fit in each individual case by the attending physician. At the nadir of lymphopenia , CIK cells are rapidly thawed at bedside and infused.
Dose and schedule of CIK cells follows the following principle 4.1 First dose for patients who have already received DLI and showed resistance : at double or triple the last DLI dose ( expressed as CD3/kg ).
4.2 First dose for patients who have not received any DLI : this will follow the conventional practice of DLI where the first dose will be 10 million CD3/kg.
4.3 Subsequent doses will be given at 4-weekly intervals allowing time to observe for development of GVHD and response.
4.3.1 If no response was observed, dose will be doubled or tripled ( depending on the size of the available aliquot ). If there is good response, dose will remain the same as the previous infusion.
4.3.2 In the presence of GVHD, infusion will be withheld till resolution of GVHD, then resumed at half or one-third of the previous dose ( depending on the size of the available aliquot).
4.4 Duration of CIK infusion will depending on the response status 4.4.1 In responding patients, 4-weekly CIK infusion will continue till a complete remission is achieved and then another 2-3 infusions beyond.
4.4.2 In patients who achieve a stable partial response, CIK infusion will continue in a 4-weekly interval, provided no adverse effect and CIK cells are available. This will continue on and stop if disease breaks through.
4.4.3 In patients where disease continues to progress after 2-3 cycles of CIK infusion, no further infusion will be given
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's Lymphoma, Hodgkin's Disease, Myelodysplastic Syndrome
- Being tested
- infusion of allogeneic CIK cells
- Keywords
- allogeneic transplant, haematological malignancies, allogeneic CIK cells
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin, Hodgkin Disease, Myelodysplastic Syndromes, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of allogeneic CIK cellsBiological
infusion of allogeneic CIK cells at graded doses
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of expansion of frozen donor mononuclear cells into CIK
Measured: 2 year
Toxicity including GVHD and marrow aplasia
Measured: 1 year from infusion for each patient
Secondary outcomes (1)
Efficacy in terms of disease response as compared to previous treatment modality ie unmanipulated DLI
Measured: 2 years from infusion for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Yeh-Ching Linn, MBBS, MRCP, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460694
- Sponsor's protocol ID
- CIK#2/2007
- Other IDs
- NMRC/1097/2006
- Acronym
- alloCIK
- Status last verified
- Feb 2017
- First submitted
- 12 Apr 2007
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. YC Linn, LC Lau, KM Hui Generation of cytokine-induced killer cells from leukemic samples with in vitro cytotoxicity against autologous and allogeneic leukemic blasts British Journal of Haematology, 2002, 116: 78-86 2. C Sheffold, M Edinger, R S Negrin A Phase I trial of autologous cytokine-indueced killer cells for transplant of relapsed Hodgkin's disease and Non Hodgkin's lymphoma Biol of Blood and Marrow Transplant 2005, 11:181-187 3. Hao Jiang, Kaiyan Liu, Chunrong Tong, Bin Jiang, Daopei Lu The efficacy of chemotherapy in combination with autologous cytokine-induced killer cellsi n acute leukemia Chinese J Internal Med 2005, 44(3): 198-201 4. Jeanette Baker, Michael R Vernais, Maki Ito et al Expansion of cytolytic CD8+ natural killer T cells with limited capacity for graft-versus- host disease induction due to interferon gamma productin Blood, 2001, 97(!)(: 2923-2931 5. Ginna G Laport, Kevin Sheehan, Robert Lowsky et al Cytokine Induced Killer (CIK) cells as post transplant immunotherapy following allogeneic haemopoietic cell transplantation (Oral session ) Blood 2006, 108 (11) #412 6.Martino Introna, Gianmaria Borleri, Elena Conti et al Infusion of donor derived Cytokine-induced Killer Cells may induce clinical remission with limited GVHD in patients relapsing after allogeneic stem cell transplantation ( poster session) Blood 2006, 108(11), #3698 7. David L Porter, Bruce L Levine, Nancy Bunin et al A phase I trial of donor lymphocyte infusions expanded and activated ex vivo via CD3/CD28 costimulation Blood 2006, 107 (4), 1325-1331
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial on Allogeneic Cytokine-induced Killer Cell Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies
- ClinicalTrials.gov ID
- NCT00460694
- Acronym / sponsor ID
- alloCIK / CIK#2/2007
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's Lymphoma, Hodgkin's Disease, Myelodysplastic Syndrome
- Keywords
- allogeneic transplant, haematological malignancies, allogeneic CIK cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Aug 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Apr 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.
Cytokine-induced killer ( CIK ) cells have been shown by our lab to be cytolytic against both autologous and allogeneic acute myeloid leukemia ( AML ) cells. Large scale expansion of CIK cells has also been shown to be feasible in healthy allogeneic stem cell donors as well as in patients undergoing mobilization for autologous transplant.
Donor lymphocyte infusion (DLI) has been shown to be active against some haematological malignancies including CML, AML, MDS,NHL and Hodgkin's disease. These donor lymphocytes can be further activated in vitro to become CIK cells. At least 2 other centers in the world have given allogeneic CIK cells for patients relapsing post allogeneic transplant for a variety of haematological malignancies. These early reports have demonstrated feasibility, absence of increased GVHD and possible efficacy in some cases.
We are proposing a Phase I /II study on the feasibility / efficacy of immunotherapy with allogeneic CIK cells for patients who relapse after allogeneic marrow transplant for their haematological malignancies. These patients have to be either refractory to conventional donor lymphocyte infusion, or need a larger number of donor lymphocyte than could be provided by unmanipulated donor lymphocytes. Donor lymphocytes will be collected and cultured in GMP facilities to maturity, then infused into patients. This will be given in graded doses at 4 weekly intervals and continued on in the absence of GVHD till remission is achieved or disease progression occurs. Patients may receive various forms of chemotherapy appropriate to the clinical condition in each case before the allogeneic CIK infusion.
Efficacy will be assessed by comparing the response to allogeneic CIK infusion vs that to due to conventional DLI, ie response to the two different treatment using DLI response as the comparator. We expect about 10 such cases to be done over the next 3 years. Significant statistics is unlikely to be generated but observation and description of the response can generate useful information for presence or not of the efficacy of such a treatment.
If clinical efficacy and superiority over conventional DLI is demonstrated, then future allogeneic CIK may take the place of DLI in this group of poor prognosis patients who relapse after allogeneic transplant .
Detailed description
- Patient inclusion criteria This trial includes only patients who have relapsed after an allogeneic transplant, who have either 1.1 No response to conventional DLI given for at least one dose, or 1.2 No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant 1,3 Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.
- Collection of peripheral blood stem cells ( PBSC ) Sibling allogeneic donors will routinely have their PBSC harvested for the purpose of infusion into the recipients. Currently our practice involves one additional day of collection to freeze as backup to be used for DLI in the event of relapse. This collection is frozen in a few aliquots, and is available for CIK culture when need arises For cord blood transplant, one issue is that DLI is not available. There is one report on growing CIK from residual cells in the bags of cord blood after infusion, then stored frozen for use in future if need arises. This does not in anyway compromise the cord blood infusion. Similarly this can be done in the case of unrelated donor transplant. This will serve as a backup in the event that donor is not available for repeat collection of lymphocyte.
- Culture of CIK cells
For culture from frozen product, this is rapidly thawed and culture started in gas permeable bags in complete medium and cytokine as detailed in SOP attached ( appendix 1 ). Culture medium and cytokine are added periodically till maturation of CIK at between 21-28 days.
For culture from residual cells in the thawed cord blood infusion bags, cells may need to undergo ficoll to remove rbc, then start culture in the similar way
- Harvesting of CIK cells
At maturity between D21-D28, all bags of CIK cells are pooled and washed using COBE 2991 cell harvester. This will ensure removal of >99.9% of the original culture medium. Cells are then frozen and aliquots sent for quality control to ensure compliance to GMP standard. This includes bacteriological and fungal culture, mycoplasma and endotoxin testing.
- Infusion of CIK cells Patients may undergo cytoreductive chemotherapy or oral immunosuppressive therapy as deemed fit in each individual case by the attending physician. At the nadir of lymphopenia , CIK cells are rapidly thawed at bedside and infused.
Dose and schedule of CIK cells follows the following principle 4.1 First dose for patients who have already received DLI and showed resistance : at double or triple the last DLI dose ( expressed as CD3/kg ).
4.2 First dose for patients who have not received any DLI : this will follow the conventional practice of DLI where the first dose will be 10 million CD3/kg.
4.3 Subsequent doses will be given at 4-weekly intervals allowing time to observe for development of GVHD and response.
4.3.1 If no response was observed, dose will be doubled or tripled ( depending on the size of the available aliquot ). If there is good response, dose will remain the same as the previous infusion.
4.3.2 In the presence of GVHD, infusion will be withheld till resolution of GVHD, then resumed at half or one-third of the previous dose ( depending on the size of the available aliquot).
4.4 Duration of CIK infusion will depending on the response status 4.4.1 In responding patients, 4-weekly CIK infusion will continue till a complete remission is achieved and then another 2-3 infusions beyond.
4.4.2 In patients who achieve a stable partial response, CIK infusion will continue in a 4-weekly interval, provided no adverse effect and CIK cells are available. This will continue on and stop if disease breaks through.
4.4.3 In patients where disease continues to progress after 2-3 cycles of CIK infusion, no further infusion will be given
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- This trial includes only patients who have relapsed after an allogeneic transplant, who have either:
- No response to conventional DLI given for at least one dose, or
- No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant
- Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.
- In view of the period taken to culture the cell to maturity, patient must have a life expectancy of more than one month. Interim measures eg chemotherapy or conventional DLI will be given during the interval so that ongoing treatment will not be compromised in any way.
Key exclusion criteria (3 listed)
- Uncontrolled infection or significant bleeding
- Unstable vital signs
- Any degree of hypoxia requiring oxygen therapy.
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 |
|---|---|---|
| infusion of allogeneic CIK cellsinfusion of allogeneic CIK cells at graded doses | Biological | – |
Primary outcome
Feasibility of expansion of frozen donor mononuclear cells into CIK
Time frame: 2 year
Toxicity including GVHD and marrow aplasia
Time frame: 1 year from infusion for each patient
1 secondary outcome
Efficacy in terms of disease response as compared to previous treatment modality ie unmanipulated DLI
Time frame: 2 years from infusion for each patient
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 10 Feb 2017.
- Background1. YC Linn, LC Lau, KM Hui Generation of cytokine-induced killer cells from leukemic samples with in vitro cytotoxicity against autologous and allogeneic leukemic blasts British Journal of Haematology, 2002, 116: 78-86 2. C Sheffold, M Edinger, R S Negrin A Phase I trial of autologous cytokine-indueced killer cells for transplant of relapsed Hodgkin's disease and Non Hodgkin's lymphoma Biol of Blood and Marrow Transplant 2005, 11:181-187 3. Hao Jiang, Kaiyan Liu, Chunrong Tong, Bin Jiang, Daopei Lu The efficacy of chemotherapy in combination with autologous cytokine-induced killer cellsi n acute leukemia Chinese J Internal Med 2005, 44(3): 198-201 4. Jeanette Baker, Michael R Vernais, Maki Ito et al Expansion of cytolytic CD8+ natural killer T cells with limited capacity for graft-versus- host disease induction due to interferon gamma productin Blood, 2001, 97(!)(: 2923-2931 5. Ginna G Laport, Kevin Sheehan, Robert Lowsky et al Cytokine Induced Killer (CIK) cells as post transplant immunotherapy following allogeneic haemopoietic cell transplantation (Oral session ) Blood 2006, 108 (11) #412 6.Martino Introna, Gianmaria Borleri, Elena Conti et al Infusion of donor derived Cytokine-induced Killer Cells may induce clinical remission with limited GVHD in patients relapsing after allogeneic stem cell transplantation ( poster session) Blood 2006, 108(11), #3698 7. David L Porter, Bruce L Levine, Nancy Bunin et al A phase I trial of donor lymphocyte infusions expanded and activated ex vivo via CD3/CD28 costimulation Blood 2006, 107 (4), 1325-1331
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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.
Yeh-Ching Linn, MBBS, MRCP principal investigator
Singapore General Hospital
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 infusion of allogeneic CIK cells in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Singapore General Hospital at 1 site in Singapore.
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 5 inclusion and 3 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 10 Feb 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 Singapore. 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?
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?
Feasibility of expansion of frozen donor mononuclear cells into CIK (time frame: 2 year). The study lists 2 primary outcomes in all. 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 NCT00460694, which also lists 1 linked publication.
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 10 Feb 2017.