Condition or disease | Intervention/treatment | Phase |
---|---|---|
B Cell Lymphomas | Drug: Nivolumab Biological: Microtransplantation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas |
Estimated Study Start Date : | July 10, 2020 |
Estimated Primary Completion Date : | March 15, 2023 |
Estimated Study Completion Date : | May 15, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1: Microtransplantation (MST)
MST:Infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
|
Biological: Microtransplantation
HLA-mismatched peripheral blood stem cells
|
Experimental: Cohort 2/2b: MST + Nivolumab
2: Microtransplantation (Day 0) + nivolumab (3 mg/kg) every 2 weeks (beginning on Day+14) 2b: Microtransplantation (Day 0) + nivolumab (1 mg/kg) every 2 weeks (beginning on Day+14). |
Drug: Nivolumab
Nivolumab (1 mg/Kg or 3 mg/kg) every 2 weeks per cohort dose level and schedule
Other Name: OPDIVO™, BMS-936558, MDX1106, ONO-4538
Biological: Microtransplantation HLA-mismatched peripheral blood stem cells
|
Experimental: Cohort 3/3b: MST + Nivolumab
3: Microtransplantation (Day 0) + nivolumab (3 mg/kg) every 2 weeks (beginning on Day-1). 3b: Microtransplantation (Day 0) + nivolumab (1 mg/kg) every 2 weeks (beginning on Day-1). |
Drug: Nivolumab
Nivolumab (1 mg/Kg or 3 mg/kg) every 2 weeks per cohort dose level and schedule
Other Name: OPDIVO™, BMS-936558, MDX1106, ONO-4538
Biological: Microtransplantation HLA-mismatched peripheral blood stem cells
|
Experimental: Cohort 4: Expansion
Microtransplantation (Day 0) + nivolumab (at RP2D)
|
Drug: Nivolumab
Nivolumab (1 mg/Kg or 3 mg/kg) every 2 weeks per cohort dose level and schedule
Other Name: OPDIVO™, BMS-936558, MDX1106, ONO-4538
Biological: Microtransplantation HLA-mismatched peripheral blood stem cells
|
In the dose escalation portion, patients will be sequentially enrolled in 3 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) of nivolumab in combination with microtransplantation is reached.
The MTD will be defined as the dose level where at most 1 out of 6 patients experience a dose limiting toxicity (DLT) and will also be the recommended phase 2 dose (RP2D) strategy.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with relapsed/refractory B cell lymphomas of the following subtypes:
Adequate organ function parameters:
Liver function:
Bone marrow reserve without transfusion defined as:
Exclusion Criteria:
Prior Treatments:
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Ahmed Galal, MD | Duke Health |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | April 8, 2019 | ||||||
First Posted Date ICMJE | April 19, 2019 | ||||||
Last Update Posted Date | March 23, 2021 | ||||||
Estimated Study Start Date ICMJE | July 10, 2020 | ||||||
Estimated Primary Completion Date | March 15, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas | ||||||
Official Title ICMJE | MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas | ||||||
Brief Summary | The purpose of this study is to find out if microtransplantation (MST) in combination with nivolumab is safe and effective in patients with relapsed or refractory B cell lymphomas. | ||||||
Detailed Description | This is a non-randomized, open-label, phase 1 study to assess the safety of nivolumab (OPDIVO™, also referred to as BMS-936558, MDX1106, and ONO-4538) in combination with microtransplantation (MST) in patients ≥ 18 years of age with relapsed or refractory B cell lymphomas. A conventional cohorts-of-3 dose-escalation phase I design will be used to determine the optimal dosing strategy of nivolumab in combination with MST. The safety of microtransplantation without nivolumab will be evaluated at the first dose level. If significant, unexpected toxicity is observed at Dose Levels 2 or 3, subsequent cohorts will switch to the alternate dosing schedule to evaluate the safety of dose-reduced nivolumab. After determination of the maximum tolerated dose level, patients will be recruited into an expansion cohort at that level. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | B Cell Lymphomas | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE |
0 | ||||||
Original Estimated Enrollment ICMJE |
38 | ||||||
Estimated Study Completion Date ICMJE | May 15, 2023 | ||||||
Estimated Primary Completion Date | March 15, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03920631 | ||||||
Other Study ID Numbers ICMJE | Pro00101349 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Responsible Party | Ahmed Galal, MD, Duke University | ||||||
Study Sponsor ICMJE | Ahmed Galal, MD | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Duke University | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |