Chronic Myelogenous LeukemiaPhase 1NCT00866346
PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation
A Phase 1 study testing PR1-primed lymphocyte (PR1-CTL) Infusion in people with Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- PR1-primed lymphocyte (PR1-CTL) Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2015
- 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 chronic myelogenous leukemia (CML) who have previously undergone allogeneic hematopoietic transplantation and have evidence of disease, as defined by a,b or c (a) >5% Philadelphia chromosome positive cells on cytogenetic studies >/= 3 months post-transplant
- (b) For patients in cytogenetic remission post-transplant, molecular evidence of disease at any time, defined as recurrence of quantitative PCR positivity for bcr-abl after achieving a molecular remission confirmed by 2 assays, 3 months apart or sooner if clinically indicated; OR a >10-fold increase in the relative expression of bcr-abl/abl detected and confirmed by a minimum of 2 consecutive PCR analysis, 3 months apart or sooner
- (c) Molecular evidence of persistent disease on Real time PCR (bcr-abl/ abl x 100 of 0.05 and not declining) >3 months post-transplantation after treatment with imatinib mesylate.
- Patients must have an HLA compatible related or unrelated donor capable of donating peripheral blood stem cells using apheresis techniques. This must be the same donor used for the original allogeneic hematopoetic transplantation. Patient must be HLA-A2 positive
- ECOG performance status < or = 2
- Serum bilirubin < or = 2 mg/dl
Show all 14Show fewer
- Serum transaminases < 4 x normal
- Serum creatinine < or = 2 mg/dl
- No active uncontrolled infection
- HIV negative
- No acute and/or chronic GVHD requiring systemic steroid therapy
- Patient is not pregnant or breast feeding.
- Signed informed consent
- Patients must be off all immunosuppressive medications for at least 2 weeks prior to study entry.
Who cannot join
- None.
About this study
Official title: A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation
Primary Objective:
To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.
Secondary Objectives:
- To evaluate the immunological response following PR1-CTL treatment
- To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months
Read the detailed description
Before treatment starts, you will have a complete physical exam, including blood (about 2 tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To collect a bone marrow sample, 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. Women who are able to have children must have a negative blood pregnancy test.
You will be treated with donor immune cells (T lymphocytes) that will specifically target certain leukemia cells in your body. Each participant will receive two doses of donor cells, 60 days apart. The second dose will be given 60 days after the first dose, at a higher dose level, as long as no serious side effects occur after the first dose and there is still disease present. Four dose levels of PR1-specific T lymphocytes will be considered. Up to 30 patients will be treated in cohorts of 3, starting at the lowest dose level, and not skipping an untried dose level when escalating. The trial will be stopped early if the lowest dose level is found to be unacceptably toxic.
These cells will be given on an outpatient basis. After each donor cell infusions, you will be followed once a week in the outpatient clinic for at least 1 month and then every 3 months for at least one year. You will have routine blood (about 2 tablespoons) and urine tests at these visits. Participants experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier.
You will also receive several other medications to help decrease the risk of infections while your immune system is weak. These include preventative antibiotics, antiviral drugs, and antifungal drugs.
Bone marrow samples will be taken before the second cell infusion, and then 8 weeks, 12 weeks, 6 months and 1 year after the second cell infusion.
This is an investigational study. A total of up to 30 patients will be take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- PR1-primed lymphocyte (PR1-CTL) Infusion
- Keywords
- Chronic Myelogenous Leukemia, CML, Allogeneic Hematopoietic Transplantation, Bone Marrow Transplant, PR1-Specific Cytotoxic T-Lymphocyte Infusion
- Medical subject headings
- 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.
PR1-primed lymphocyte (PR1-CTL) InfusionBiological
Also called AHT, Allogenic Hemotopoietic Transplantation, PR1-CTL
Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart.
Starting infusion dose 1 x 106 nucleated cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| PR1-CTL | Experimental | Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart.
Starting infusion dose 1 x 106 nucleated cells/kg. Receives: Biological: PR1-primed lymphocyte (PR1-CTL) Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL)
Measured: Continuous reassessment, infusion day 0 and second infusion day 60+/- 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2015 (estimated)
Why it stopped: Study failed to accrue any patients due to regulatory issues with PR1 vaccine and T cell production.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muzaffar H. Qazilbash, MD, Principal investigator, UT MD Anderson Cancer CenterRichard E. Champlin, MD, BS, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866346
- Sponsor's protocol ID
- 2003-0564
- Other IDs
- NCI-2012-01651
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2009
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation
- ClinicalTrials.gov ID
- NCT00866346
- Acronym / sponsor ID
- 2003-0564
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Chronic Myelogenous Leukemia, CML, Allogeneic Hematopoietic Transplantation, Bone Marrow Transplant, PR1-Specific Cytotoxic T-Lymphocyte Infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study failed to accrue any patients due to regulatory issues with PR1 vaccine and T cell production.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2015 (estimated)
- First posted
- 20 Mar 2009 (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.
Primary Objective:
To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.
Secondary Objectives:
- To evaluate the immunological response following PR1-CTL treatment
- To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months
Detailed description
Before treatment starts, you will have a complete physical exam, including blood (about 2 tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To collect a bone marrow sample, 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. Women who are able to have children must have a negative blood pregnancy test.
You will be treated with donor immune cells (T lymphocytes) that will specifically target certain leukemia cells in your body. Each participant will receive two doses of donor cells, 60 days apart. The second dose will be given 60 days after the first dose, at a higher dose level, as long as no serious side effects occur after the first dose and there is still disease present. Four dose levels of PR1-specific T lymphocytes will be considered. Up to 30 patients will be treated in cohorts of 3, starting at the lowest dose level, and not skipping an untried dose level when escalating. The trial will be stopped early if the lowest dose level is found to be unacceptably toxic.
These cells will be given on an outpatient basis. After each donor cell infusions, you will be followed once a week in the outpatient clinic for at least 1 month and then every 3 months for at least one year. You will have routine blood (about 2 tablespoons) and urine tests at these visits. Participants experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier.
You will also receive several other medications to help decrease the risk of infections while your immune system is weak. These include preventative antibiotics, antiviral drugs, and antifungal drugs.
Bone marrow samples will be taken before the second cell infusion, and then 8 weeks, 12 weeks, 6 months and 1 year after the second cell infusion.
This is an investigational study. A total of up to 30 patients will be take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PR1-CTL | Experimental | Biological: PR1-primed lymphocyte (PR1-CTL) InfusionTwo infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with chronic myelogenous leukemia (CML) who have previously undergone allogeneic hematopoietic transplantation and have evidence of disease, as defined by a,b or c (a) >5% Philadelphia chromosome positive cells on cytogenetic studies >/= 3 months post-transplant
- (b) For patients in cytogenetic remission post-transplant, molecular evidence of disease at any time, defined as recurrence of quantitative PCR positivity for bcr-abl after achieving a molecular remission confirmed by 2 assays, 3 months apart or sooner if clinically indicated; OR a >10-fold increase in the relative expression of bcr-abl/abl detected and confirmed by a minimum of 2 consecutive PCR analysis, 3 months apart or sooner
- (c) Molecular evidence of persistent disease on Real time PCR (bcr-abl/ abl x 100 of 0.05 and not declining) >3 months post-transplantation after treatment with imatinib mesylate.
- Patients must have an HLA compatible related or unrelated donor capable of donating peripheral blood stem cells using apheresis techniques. This must be the same donor used for the original allogeneic hematopoetic transplantation. Patient must be HLA-A2 positive
- ECOG performance status < or = 2
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| PR1-primed lymphocyte (PR1-CTL) InfusionAlso: AHT, Allogenic Hemotopoietic Transplantation, PR1-CTLTwo infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg. | Biological | PR1-CTL |
Primary outcome
Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL)
Time frame: Continuous reassessment, infusion day 0 and second infusion day 60+/- 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- UT 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.
Muzaffar H. Qazilbash, MD principal investigator
UT MD Anderson Cancer Center
Richard E. Champlin, MD, BS study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PR1-primed lymphocyte (PR1-CTL) Infusion in people with Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center.
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 14 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) (time frame: Continuous reassessment, infusion day 0 and second infusion day 60+/- 7). 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 4 Mar 2014.