Leukemia, Myeloid, AcutePhase 1NCT00569179
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
A Phase 1 study testing CliniMACS CD34 Reagent System in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoid, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes
- What is being tested?
- CliniMACS CD34 Reagent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically documented AML, ALL, MDS, CML,
- Identification of haploidentical donor
- LVEF > 45% corrected
- DLCO > 50% predicted
- Serum Creatinine <= 2 mg/dL
- Bilirubin < 2 x ULN
Show all 9Show fewer
- AST, ALT < 2 x ULN
- Age ≤ 65 years
- Performance Status 0-1
Who cannot join
- Patients relapsing <6 months after autologous SCT are not eligible.
- Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
- No HIV disease
- Non-pregnant and non-nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic
- Being tested
- CliniMACS CD34 Reagent System
- Keywords
- Myeloid Malignancies, Bone Marrow Transplant, AML, ALL, MDS, CML
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACS CD34 Reagent SystemDevice
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
| Study group | Role | What they receive |
|---|---|---|
| Alloreactive NK cell infusion | Experimental | Escalating doses of alloreactive NK cells. Receives: Device: CliniMACS CD34 Reagent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
Measured: through Day 128
Secondary outcomes (5)
Assess toxicity associated with the infusion of alloreactive NK cells
Measured: through Day 128
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
Measured: through Day 128
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
Measured: through Day 128
Describe the frequency and type of infections occurring within the first year following transplantation.
Measured: through Day 128
Describe immune reconstitution following transplantation.
Measured: through Day 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2010
- Study completionDec 2010
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Farag, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569179
- Sponsor's protocol ID
- 0612-26/ IUCRO-0179
- Status last verified
- Aug 2015
- First submitted
- 5 Dec 2007
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
- ClinicalTrials.gov ID
- NCT00569179
- Acronym / sponsor ID
- 0612-26/ IUCRO-0179
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic
- Keywords
- Myeloid Malignancies, Bone Marrow Transplant, AML, ALL, MDS, CML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Dec 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 this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alloreactive NK cell infusion | Experimental | Device: CliniMACS CD34 Reagent SystemEscalating doses of alloreactive NK cells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically documented AML, ALL, MDS, CML,
- Identification of haploidentical donor
- LVEF > 45% corrected
- DLCO > 50% predicted
- Serum Creatinine <= 2 mg/dL
Key exclusion criteria (4 listed)
- Patients relapsing <6 months after autologous SCT are not eligible.
- Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
- No HIV disease
- Non-pregnant and non-nursing
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 |
|---|---|---|
| CliniMACS CD34 Reagent SystemAlloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device. | Device | Alloreactive NK cell infusion |
Primary outcome
Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
Time frame: through Day 128
5 secondary outcomes
Assess toxicity associated with the infusion of alloreactive NK cells
Time frame: through Day 128
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
Time frame: through Day 128
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
Time frame: through Day 128
Describe the frequency and type of infections occurring within the first year following transplantation.
Time frame: through Day 128
Describe immune reconstitution following transplantation.
Time frame: through Day 128
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
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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.
Sherif Farag, MD, PhD principal investigator
Indiana 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 CliniMACS CD34 Reagent System in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoid, run by Indiana University 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 9 inclusion and 4 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 31 Aug 2015. 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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies. (time frame: through Day 128). 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 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.