Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma
Conditions
Keywords
Lymphoma, Large B-Cell, Diffuse, Transformed Follicular Lymphoma, Stem cell transplantation, Relapsed, Refractory
Brief summary
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
Interventions
DRUGCT-011
IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Sponsors
CureTech Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient's age is 18 years or older, both genders. 2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage. 3. The lymphoma is chemosensitive. 4. The lymphoma did not progress since pre-transplant chemotherapy. 5. ECOG performance status 0-1.
Exclusion criteria
1. Serious other illness. 2. Active autoimmune disease. 3. Type 1 diabetes. 4. Known immune deficiency. 5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma. 6. Active bacterial, fungal, or viral infection. 7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia. 8. Pregnant or nursing (positive pregnancy test). 9. Other concurrent clinical study or investigational therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). | PFS (progression-free survival ) will be determined at the eligible patient populations |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). |
Countries
India, Israel, United States
Participant flow
Recruitment details
22 February 2008 (first patient enrolled) to 02 June 2011 (last patient completed) The study was carried out in medical centers
Participants by arm
| Arm | Count |
|---|---|
| CT-011 Antibody CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 21 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CT-011 Antibody |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 13 |
| Region of Enrollment Chile | 1 participants |
| Region of Enrollment India | 3 participants |
| Region of Enrollment Israel | 10 participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / 72 |
| serious Total, serious adverse events | 23 / 72 |
Outcome results
Primary
Progression-free Survival
PFS (progression-free survival ) will be determined at the eligible patient populations
Time frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
Population: Patients who did not meet key study entry criteria were excluded from the eligible data set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT-011 Antibody | Progression-free Survival | 72 Percent |
Secondary
Overall Survival
Time frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT-011 Antibody | Overall Survival | 85 Percent |