AnemiaPhase 2NCT02530515

Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Ex Vivo-activated Autologous Lymph Node Lymphocytes and Laboratory Biomarker Analysis in people with Anemia and Cancer Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Anemia, Cancer Fatigue, Chronic Lymphocytic Leukemia
What is being tested?: Ex Vivo-activated Autologous Lymph Node Lymphocytes and Laboratory Biomarker Analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2015to 30 Apr 2018
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:
Weight loss of more than 10% over the preceding 6 months; or
Extreme fatigue attributable to progressive disease; or
Fever or night sweats without evidence of infection; or
Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or

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Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time < 6 months); or
Prolymphocytic or Richter's transformation; or
Patients with CLL who have received at least one prior line of therapy; or
Patients with CLL who have frequent infections and/or recurrent secondary cancers
No active central nervous system (CNS) disease
All patients must have a Karnofsky performance score > 60%
Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
Patients must not have untreated or uncontrolled life-threatening infection
Patients must sign informed consent

Who cannot join

Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Conditions: Anemia, Cancer Fatigue, Chronic Lymphocytic Leukemia, Fever, Infectious Disorder, Lymphadenopathy
Being tested: Ex Vivo-activated Autologous Lymph Node Lymphocytes, Laboratory Biomarker Analysis
Medical subject headings: Anemia, Leukemia, Lymphocytic, Chronic, B-Cell, Fever, Communicable Diseases, Lymphadenopathy, Lymphocytosis, Leukemia, Prolymphocytic, Neoplasms, Second Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ex Vivo-activated Autologous Lymph Node LymphocytesBiological
Also called X-ACT, X-ACT Autologous Lymph Node Lymphocytes
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies

Study groups in NCT02530515
Study group	Role	What they receive
Treatment (ex vivo autologous lymph node lymphocytes)	Experimental	Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0. Receives: Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in >50% of patients enrolled.
Measured: Enrollment up to day 100 post T cell infusion for each arm.

Secondary outcomes (3)

Immune Reconstitution
To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia
Measured: Up to 1 year
Overall Response Rates
The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.
Measured: Up to 1 year
Incidence of Infections
To study the incidence of infections for up to 1 year following activated T cell infusion
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201530 Apr 2018

First posted21 Aug 2015 (estimated)
Study start18 Dec 2015
Primary completion30 Apr 2018
Study completion30 Apr 2018

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 AnemiaStudies 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: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02530515
Sponsor's protocol ID: 2014-0830
Other IDs: NCI-2015-01546, 2014-0830, P30CA016672
Status last verified: Oct 2019
First submitted: 19 Aug 2015
Last updated: 29 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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Myelodysplastic Syndromes
RecruitingObservational study
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
ClinicalTrials.gov ID: NCT02530515
Acronym / sponsor ID: 2014-0830
Conditions: Anemia, Cancer Fatigue, Chronic Lymphocytic Leukemia, Fever, Infectious Disorder, Lymphadenopathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 18 Dec 2015 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 21 Aug 2015 (estimated)
Results: Posted 29 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (ex vivo autologous lymph node lymphocytes)	Experimental	Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes, Other: Laboratory Biomarker AnalysisPatients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (15 listed)

All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
No active central nervous system (CNS) disease
All patients must have a Karnofsky performance score > 60%
Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
Patients must not have untreated or uncontrolled life-threatening infection

Key exclusion criteria (2 listed)

Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

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
Ex Vivo-activated Autologous Lymph Node LymphocytesAlso: X-ACT, X-ACT Autologous Lymph Node LymphocytesGiven IV	Biological	Treatment (ex vivo autologous lymph node lymphocytes)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (ex vivo autologous lymph node lymphocytes)

Primary outcome

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
Time frame: Enrollment up to day 100 post T cell infusion for each arm.
Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in >50% of patients enrolled.

3 secondary outcomes

Immune Reconstitution
Time frame: Up to 1 year
Overall Response Rates
Time frame: Up to 1 year
Incidence of Infections
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 29 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	0	0
Arm B	0	0
Arm C	8	8

Primary outcome: Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.

Time frame: Enrollment up to day 100 post T cell infusion for each arm.. Count of participants. Unit: Participants

Measure	Arm A n = 0	Arm B n = 0	Arm C n = 8
Sucessful Target T-cell Dose	–	–	7
Feasibility	–	–	7

Population analysed: Patients with CLL.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 100 Days post T cell infusion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 0	0 of 0	0
Arm B	0 of 0	0 of 0	0
Arm C	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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Not yet recruitingObservational study
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RecruitingPhase 1/2
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Myelodysplastic Syndromes
RecruitingObservational study
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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.

Chitra Hosing 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?

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 2 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 29 Oct 2019. 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 29 Oct 2019). 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?

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT. (time frame: Enrollment up to day 100 post T cell infusion for each arm.). 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 NCT02530515.

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 29 Oct 2019.