Loading clinical trials...

Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas

MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas

NCT03920631•Ahmed Galal, MD

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with relapsed/refractory B cell lymphomas of the following subtypes:
•* Diffuse large B-cell lymphoma (DLBCL)
•* High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 translocations (DHL/THL)
•* B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (GZL)
•* Primary mediastinal large B-cell lymphoma (PMBCL)
•* Mantle cell lymphoma (MCL)
•* Follicular lymphoma (FL)
•* Marginal zone lymphoma (MZL)
•* Lymphoplasmacytic Lymphoma / Waldenstrom Macroglobulinemia (LPL/WM)
•* Hodgkin lymphoma (HL)
+18 more criteria

Exclusion Criteria

•1. Prior Treatments:
•1. Prior treatment with allogeneic HSCT.
•2. Treatment with CAR-T cells within 6 months of study enrollment.
•3. Treatment with an immune checkpoint inhibitor within 3 months of study enrollment.
•4. Prior grade 3 or higher toxicities with immune checkpoint inhibitor use, excluding lymphopenia, asymptomatic amylase or lipase elevation or laboratory abnormalities that correct to grade 1 within 72 hours.
•5. Chemotherapy, radiation or surgical resection of malignancy within 2 weeks prior to the start of lymphodepleting chemotherapy (washout period).
•2. Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigator's opinion is likely to interfere with participation in this clinical trial.
•3. Known active CNS involvement by malignancy.
•4. History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
•5. Active replication of hepatitis B or active hepatitis C (HCV RNA positive). Those with prior disease who are PCR negative at enrollment and meet liver function eligibility criterion are eligible.
+8 more criteria

Locations (1)

Duke University

Durham, North Carolina, United States

Key Dates

Start Date

July 10, 2020

Primary Completion Date

March 15, 2023

Completion Date

May 15, 2023

Last Updated

March 23, 2021

Conditions

B Cell Lymphomas

Interventions

Nivolumab

DRUG

Microtransplantation

BIOLOGICAL

AZD6738 First Time in Patient Multiple Ascending Dose Study

NCT01955668

11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL),Prolymphocytic Leukaemia (PLL)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions