LeukemiaPhase 2NCT02210065
Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation
A Phase 2 study testing Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
- 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
- 3 Mar 2015to 13 May 2019
- Phase
- Phase 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
- STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
- Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
- Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have <5% blasts in the bone marrow.
- Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
- Patients >/= 18 years of age.
- Karnofsky greater than or equal to 80%.
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- CMV seropositive.
- Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
- Hgb greater than 10 g/L.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
- Negative pregnancy test in female patients of childbearing potential.
- STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): CMV reactivation defined as CMV DNAemia >/= 137 copies/ml.
- Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)> 0.5 X 10^3/for 3 consecutive days.
- Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent.
- Negative pregnancy test in female patients of childbearing potential.
Who cannot join
- STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
- CMV seronegative.
- Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.
- STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
- Patients receiving ATG, or Campath within 28 days of CMV reactivation.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
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- Patients who have received donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute GVHD grades II-IV.
- Active and uncontrolled relapse of malignancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
Read the detailed description
The CTLs:
Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your transplant, the blood will be used to create CTLs. To create CTLs, blood cells are grown in the laboratory and trained to kill CMV. If the blood is not used to make the CTLs within 3 years, it will be destroyed.
CTL Administration:
If your CMV becomes active after your stem cell transplant, you will receive the CTLs through a needle in your vein over 1-5 minutes one time, within 72 hours after CMV becomes active again. Before you receive the CTLs, you will receive Benadryl (diphenhydramine) and Tylenol (acetaminophen) by mouth to help reduce the risk of side effects. This can be done in either the hospital (if not yet discharged after your transplant) or in the outpatient clinic (if you are discharged).
Your vital signs will be monitored at the end of the infusion, and then at 30 and 60 minutes after the infusion. Your oxygen level will be measured by pulse oximetry. For this test, a clothespin-shaped clip will be placed on your finger for at least 30 minutes. If you are an outpatient, you will remain in the clinic for at least 1 hour after the CTL infusion.
If the CMV does not become active again after your stem cell transplant, you will not receive the CTL infusion.
Study Visits:
If the CMV does not become active again after your stem cell transplant, you will not receive the CTL infusion and your follow-up care will be done as per post-transplant standard of care.
If you receive the CTL infusion, you will have the tests/procedures listed below.
Within 48 hours before the CTL infusion:
- You will have a physical exam.
- Blood (about 6 tablespoons) will be drawn for routine tests and to check your kidney and liver function. Part of blood draw will be used for a pregnancy test for women who are able to become pregnant. To take part in this study, you must not be pregnant.
Once a week for 4 weeks, blood (about 4-8 tablespoons) will be drawn to check the level of CMV infection in your body. This may be done more often, if you doctor thinks it is needed.
About 1, 2, 3, and 4 weeks, and then about 3, 6, and 12 months after the CTL infusion:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check your kidney and liver function.
Blood (about 4 tablespoons) will be drawn for tests to learn more about the way the CTLs are working and how long they last in the body. This blood will be drawn before the CTL infusion, and then about 2 weeks, 4 weeks, 3 months, and 6 months after the CTL infusion. If possible, the blood needed for these tests will be collected during blood draws for routine tests so that no additional needle sticks will be needed.
Follow-Up Visits:
Once a week for 6 weeks, and then about 3, 6, 9, and 12 months after the CTL infusion, you will be checked for signs of graft-versus-host disease (GVHD) at every clinic visit. You were told about GVHD at the time of being prepared for transplant.
Length of Study:
Your participation on this study will end after your last follow-up visit about 12 months after the CTL infusion.
This is an investigational study. The use of CTLs to treat CMV infection is not FDA approved. At this time, CTLs are only being used to treat infections in research studies.
Up to 105 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
- Keywords
- Leukemia, Lymphoma, Blood And Marrow Transplantation, Hematological malignancies, Cytotoxic T cells, CTL, Cytomegalovirus, CMV, Allogeneic hematopoietic stem cell transplantation, HSCT
- Medical subject headings
- Leukemia, Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)Biological
CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) | Experimental | CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. Receives: Biological: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Non-Relapse Mortality
Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.
Measured: 6 months
Success Rate of Cytotoxic T Cells
Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start3 Mar 2015
- Primary completion13 May 2019
- Study completion13 May 2019
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biotec B.V. & Co. KG
- Responsible party
- Sponsor
- Investigators
- Betul Oran, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210065
- Sponsor's protocol ID
- 2013-0620
- Other IDs
- NCI-2014-02335
- Status last verified
- Mar 2020
- First submitted
- 4 Aug 2014
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02210065
- Acronym / sponsor ID
- 2013-0620
- Keywords
- Leukemia, Lymphoma, Blood And Marrow Transplantation, Hematological malignancies, Cytotoxic T cells, CTL, Cytomegalovirus, CMV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Miltenyi Biotec B.V. & Co. KG
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
Detailed description
The CTLs:
Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your transplant, the blood will be used to create CTLs. To create CTLs, blood cells are grown in the laboratory and trained to kill CMV. If the blood is not used to make the CTLs within 3 years, it will be destroyed.
CTL Administration:
If your CMV becomes active after your stem cell transplant, you will receive the CTLs through a needle in your vein over 1-5 minutes one time, within 72 hours after CMV becomes active again. Before you receive the CTLs, you will receive Benadryl (diphenhydramine) and Tylenol (acetaminophen) by mouth to help reduce the risk of side effects. This can be done in either the hospital (if not yet discharged after your transplant) or in the outpatient clinic (if you are discharged).
Your vital signs will be monitored at the end of the infusion, and then at 30 and 60 minutes after the infusion. Your oxygen level will be measured by pulse oximetry. For this test, a clothespin-shaped clip will be placed on your finger for at least 30 minutes. If you are an outpatient, you will remain in the clinic for at least 1 hour after the CTL infusion.
If the CMV does not become active again after your stem cell transplant, you will not receive the CTL infusion.
Study Visits:
If the CMV does not become active again after your stem cell transplant, you will not receive the CTL infusion and your follow-up care will be done as per post-transplant standard of care.
If you receive the CTL infusion, you will have the tests/procedures listed below.
Within 48 hours before the CTL infusion:
- You will have a physical exam.
- Blood (about 6 tablespoons) will be drawn for routine tests and to check your kidney and liver function. Part of blood draw will be used for a pregnancy test for women who are able to become pregnant. To take part in this study, you must not be pregnant.
Once a week for 4 weeks, blood (about 4-8 tablespoons) will be drawn to check the level of CMV infection in your body. This may be done more often, if you doctor thinks it is needed.
About 1, 2, 3, and 4 weeks, and then about 3, 6, and 12 months after the CTL infusion:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check your kidney and liver function.
Blood (about 4 tablespoons) will be drawn for tests to learn more about the way the CTLs are working and how long they last in the body. This blood will be drawn before the CTL infusion, and then about 2 weeks, 4 weeks, 3 months, and 6 months after the CTL infusion. If possible, the blood needed for these tests will be collected during blood draws for routine tests so that no additional needle sticks will be needed.
Follow-Up Visits:
Once a week for 6 weeks, and then about 3, 6, 9, and 12 months after the CTL infusion, you will be checked for signs of graft-versus-host disease (GVHD) at every clinic visit. You were told about GVHD at the time of being prepared for transplant.
Length of Study:
Your participation on this study will end after your last follow-up visit about 12 months after the CTL infusion.
This is an investigational study. The use of CTLs to treat CMV infection is not FDA approved. At this time, CTLs are only being used to treat infections in research studies.
Up to 105 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) | Experimental | Biological: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
- Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
- Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have <5% blasts in the bone marrow.
- Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
- Patients >/= 18 years of age.
Key exclusion criteria (9 listed)
- STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
- CMV seronegative.
- Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.
- STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
- Patients receiving ATG, or Campath within 28 days of CMV reactivation.
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 |
|---|---|---|
| Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. | Biological | Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) |
Primary outcome
Number of Participants With Non-Relapse Mortality
Time frame: 6 months
Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.
Success Rate of Cytotoxic T Cells
Time frame: 28 days
Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas 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.
Betul Oran, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center 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 15 inclusion and 9 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 17 Mar 2020. 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 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 17 Mar 2020). 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 Participants With Non-Relapse Mortality (time frame: 6 months). 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?
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 17 Mar 2020.