Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT01630564
Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies
A Phase 1 study testing Aldesleukin, Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion and Umbilical Cord Blood-Derived Lymphocyte Therapy in people with Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Aldesleukin, Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion and Umbilical Cord Blood-Derived Lymphocyte Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2013to 30 May 2018
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Umbilical cord blood (UCB) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- Performance score of at least 80% by Karnofsky or performance status (PS) < 3 (Eastern Cooperative Oncology Group [ECOG]) (age >= 12 years), or Lansky Play-performance scale of at least 60% or greater (age < 12 years)
- Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent
Who cannot join
- Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
- Patients with active (untreated) central nervous system (CNS) disease
- Any active GVHD
- Active invasive infections
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.
SECONDARY OBJECTIVES:
- To determine the complete remission rate and overall response as a result of CLI infusion.
II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.
IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI infusion.
OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
After completion of study treatment, patients are followed up for 100 days.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Aldesleukin, Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion, Umbilical Cord Blood-Derived Lymphocyte Therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinBiological
Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Ex Vivo-Expanded Cord Blood Progenitor Cell InfusionProcedure or surgery
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Umbilical Cord Blood-Derived Lymphocyte TherapyBiological
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
| Study group | Role | What they receive |
|---|---|---|
| Treatment (T-cell infusion) | Experimental | Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins. Receives: Biological: Aldesleukin; Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion; Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%
Dose limiting toxicity is defined as grade IV graft-versus-host disease (GVHD), grades 3-4 acute GVHD occurring within 45 days of the study T cell infusion, grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic), grade 4 cytopenia, or any grade 4 or 5 organ based (non-hematologic) toxicity.
Measured: Up to day 45
Secondary outcomes (7)
Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall
Measured: Up to day 100
Numbers of patients treated at the MTD with grade 2-4 GVHD
Estimated with an exact 95% binomial confidence interval.
Measured: Up to day 100
Proportion of patients with remission post-infusion
Estimated with an exact 95% binomial confidence interval.
Measured: Up to day 100
Proportion of patients achieving chimerism post-infusion
Estimated with an exact 95% binomial confidence interval.
Measured: Up to day 100
Proportion of patients with cytopenia post-infusion
Estimated with an exact 95% binomial confidence interval.
Measured: Up to day 100
Proportion of patients that relapse after infusion
Estimated with an exact 95% binomial confidence interval.
Measured: Up to day 100
Disease-free survival
Estimated with the Kaplan-Meier product limit estimator.
Measured: Up to day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study start11 Mar 2013
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sairah Ahmed, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630564
- Sponsor's protocol ID
- 2011-1178
- Other IDs
- NCI-2013-00385, 2011-1178, P30CA016672
- Status last verified
- Nov 2018
- First submitted
- 26 Jun 2012
- Last updated
- 13 Nov 2018
- Results posted
- No
- 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 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
- ClinicalTrials.gov ID
- NCT01630564
- Acronym / sponsor ID
- 2011-1178
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 28 Jun 2012 (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.
This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.
SECONDARY OBJECTIVES:
- To determine the complete remission rate and overall response as a result of CLI infusion.
II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.
IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI infusion.
OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
After completion of study treatment, patients are followed up for 100 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (T-cell infusion) | Experimental | Biological: Aldesleukin, Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion, Biological: Umbilical Cord Blood-Derived Lymphocyte TherapyPatients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Umbilical cord blood (UCB) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- Performance score of at least 80% by Karnofsky or performance status (PS) < 3 (Eastern Cooperative Oncology Group [ECOG]) (age >= 12 years), or Lansky Play-performance scale of at least 60% or greater (age < 12 years)
- Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent
Key exclusion criteria (5 listed)
- Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
- Patients with active (untreated) central nervous system (CNS) disease
- Any active GVHD
- Active invasive infections
- Pregnant or breast-feeding
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 |
|---|---|---|
| AldesleukinAlso: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin | Biological | Treatment (T-cell infusion) |
| Ex Vivo-Expanded Cord Blood Progenitor Cell InfusionUndergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin | Procedure or surgery | Treatment (T-cell infusion) |
| Umbilical Cord Blood-Derived Lymphocyte TherapyUndergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin | Biological | Treatment (T-cell infusion) |
Primary outcome
Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%
Time frame: Up to day 45
Dose limiting toxicity is defined as grade IV graft-versus-host disease (GVHD), grades 3-4 acute GVHD occurring within 45 days of the study T cell infusion, grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic), grade 4 cytopenia, or any grade 4 or 5 organ based (non-hematologic) toxicity.
7 secondary outcomes
Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall
Time frame: Up to day 100
Numbers of patients treated at the MTD with grade 2-4 GVHD
Time frame: Up to day 100
Proportion of patients with remission post-infusion
Time frame: Up to day 100
Proportion of patients achieving chimerism post-infusion
Time frame: Up to day 100
Proportion of patients with cytopenia post-infusion
Time frame: Up to day 100
Proportion of patients that relapse after infusion
Time frame: Up to day 100
Disease-free survival
Time frame: Up to day 100
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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.
Sairah Ahmed 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 1 study testing Aldesleukin, Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion and Umbilical Cord Blood-Derived Lymphocyte Therapy in people with Hematopoietic and Lymphoid Cell Neoplasm, 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 5 inclusion and 5 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 13 Nov 2018. 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. 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?
Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30% (time frame: Up to day 45). 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 13 Nov 2018.