Trial Outcomes & Findings for Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia (NCT NCT02530515)

Last Updated: 2019-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Enrollment up to day 100 post T cell infusion for each arm.

Results posted on

2019-10-29

Participant Flow

Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.

Participant milestones

Participant milestones
Measure	Arm A Receive lymphodepletion chemotherapy followed by activated T-cell infusion	Arm B Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L	Arm C Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
Overall Study STARTED	0	0	8
Overall Study COMPLETED	0	0	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A Receive lymphodepletion chemotherapy followed by activated T-cell infusion	Arm B Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L	Arm C n=8 Participants Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	—	—	74.5 years n=5 Participants	74.5 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Enrollment up to day 100 post T cell infusion for each arm.

Population: Patients with CLL.

Outcome measures

Outcome measures
Measure	Arm A Receive lymphodepletion chemotherapy followed by activated T-cell infusion	Arm B Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L	Arm C n=8 Participants Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT. Sucessful Target T-cell Dose	—	—	7 Participants
Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT. Feasibility	—	—	7 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Data was not collected due to low accrual

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Data was not collected due to low accrual

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Data was not collected due to low accrual

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

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm C

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Chitra Hosing / Stem Cell Transplantation

UT MD Anderson Cancer Center

Phone: (713) 745-3219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A Receive lymphodepletion chemotherapy followed by activated T-cell infusion	Arm B Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L	Arm C n=8 participants at risk Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion
Respiratory, thoracic and mediastinal disorders Pneumonitis	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	50.0% 4/8 • Number of events 4 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Cardiac disorders Hypertension	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	25.0% 2/8 • Number of events 2 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Investigations Platelet Count Decreased	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	25.0% 2/8 • Number of events 2 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Infections and infestations Eye Infection	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Gastrointestinal disorders Mucositis	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Infections and infestations Nail Infection	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Infections and infestations Sinusitis	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Blood and lymphatic system disorders Anemia	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	37.5% 3/8 • Number of events 3 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Metabolism and nutrition disorders Anorexia	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Gastrointestinal disorders Constipation	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
General disorders Edema limbs	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
General disorders Fatigue	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Ear and labyrinth disorders Hearing impaired	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Metabolism and nutrition disorders Hypercalcemia	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
Skin and subcutaneous tissue disorders Skin Other	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	— 0/0 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.	12.5% 1/8 • Number of events 1 • Up to 100 Days post T cell infusion. Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.