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Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma | Clinical Trials | Clareo Health

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Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Oral Azacitidine (CC-486) Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03450343•Medical University of South Carolina

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and tolerability of adding oral azacitidine to the chemotherapy combination R-ICE. This study will also look at whether or not disease outcomes improve with the combination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologic confirmation of relapsed/refractory disease of one of the following:
•* DLBCL
•* Transformed DLBCL (from follicular lymphoma or marginal zone lymphoma but not from CLL)
•* Grade 3B follicular lymphoma
•* B-Cell lymphoma unclassifiable with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma
•* Primary mediastinal B cell lymphoma
•2. Eligible for high dose chemotherapy and autologous stem cell transplant determined by treating physician
•3. Measurable disease on cross section imaging by PET and/or CT that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria. See Section 12.1.
•4. At least 18 years old
•5. Able to understand and voluntarily sign consent prior to any study related assessments or procedures are performed.
+20 more criteria

Exclusion Criteria

•1. Women who are pregnant or breast-feeding. Lactating women must agree not to breast feed while taking CC-486 and for at least 90 days after the last dose. WOCBP will have a serum pregnancy test within 72 hours before starting study treatment on day -6. Pregnancy test must be negative in order to move forward with study treatment.
•2. More than three prior treatments for the large cell component of lymphoma (i.e. induction chemotherapy and salvage chemotherapy). Radiation therapy does not count as a line of therapy.
•3. Patients with history or active CNS lymphoma
•4. Previous history of autologous or allogeneic stem cell transplantation
•5. Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
•6. History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
•7. History of stroke or intracranial hemorrhage within 6 months prior to registration.
•8. Prior history of malignancy other than DLBCL unless subject is free of disease for more than 2 years from signing consent. Exceptions include the following:
•1. Basal cell carcinoma of the skin
•2. Squamous cell carcinoma of the skin
+14 more criteria

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

April 4, 2019

Primary Completion Date

August 31, 2023

Completion Date

January 30, 2024

Last Updated

October 28, 2024

Enrollment

ACTUAL participants

Conditions

Large B-Cell Diffuse Lymphoma

Interventions

Oral azacitidine

DRUG

R-ICE

DRUG

Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies

NCT03151057

B Cells-TumorsB Cell Chronic Lymphocytic Leukemia+3 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: October 28, 2024Data 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.

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