Trial Outcomes & Findings for Cytokine Induced Killer (CIK) Cells In Leukemia Patients (NCT NCT01186809)

Results Overview

The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Clinical response was measured at 100 days after the completion of the cell therapy program.

Results posted on

2019-01-23

Participant Flow

A total of 74 patients were enrolled in the study from July 2009 to September 2016

Participant milestones

Participant milestones
Measure	Cytokine Induced Killer Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal.
Overall Study STARTED	73
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Cytokine Induced Killer Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal.
Overall Study Death	30

Baseline Characteristics

Cytokine Induced Killer (CIK) Cells In Leukemia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytokine Induced Killer n=73 Participants Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals
Age, Categorical <=18 years	15 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	34 Participants n=99 Participants
Sex: Female, Male Male	39 Participants n=99 Participants
Region of Enrollment Italy	73 participants n=99 Participants

PRIMARY outcome

Timeframe: Clinical response was measured at 100 days after the completion of the cell therapy program.

The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale

Outcome measures

Outcome measures
Measure	Cytokine Induced Killer n=73 Participants Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal.
Safety Measures	0 participants

SECONDARY outcome

Timeframe: The clinical response will be registered at day +100 after the last Cytokine Induced Killer (CIK) cell infusion

The proportion of patients achieving a complete, a partial or a hematologic improvement in responses to the experimental infusion of cytokine induced killer (CIK)cells

Outcome measures

Outcome data not reported

Adverse Events

Cytokine Induced Killer

Serious events: 8 serious events

Other events: 16 other events

Deaths: 31 deaths

Serious adverse events

Serious adverse events
Measure	Cytokine Induced Killer n=73 participants at risk Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal.
Gastrointestinal disorders aGVHD grade III; IV	6.8% 5/73 • Number of events 5 • three years;
Blood and lymphatic system disorders hemolitic anemia	1.4% 1/73 • Number of events 1 • three years;
Gastrointestinal disorders severe chronic GVHD	2.7% 2/73 • Number of events 2 • three years;

Other adverse events

Other adverse events
Measure	Cytokine Induced Killer n=73 participants at risk Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK) in vitro expanded Cytokine Induced Killer (CIK) cells: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals This is a phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded CIK cells. Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor CIK cells will be administered according to a dose escalating program, starting 3 weeks after second DLI. CIK administrations will be separated by 3 weeks intervals. Standard treatment with unmanipulated DLI will be offered to patients refusing the proposal.
Skin and subcutaneous tissue disorders aGvHD	9.6% 7/73 • Number of events 7 • three years;
Skin and subcutaneous tissue disorders cGvHD	12.3% 9/73 • Number of events 9 • three years;

Additional Information

Prof Alessandro Rambaldi

Asst Papa Giovanni XXIII

Phone: +390352673681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place