Clinical trial · Interventional

MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma

HM-225: Measurable Residual Disease (MRD) Guided De-intensification of Bendamustine/Rituximab (BR) for Indolent Non-Hodgkin Lymphoma

NCT06557330CI-TRIAL-00084335not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Indolent Non-hodgkin Lymphoma	Indolent Non-Hodgkin Lymphoma	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Bendamustine	Drug	Bendamustine	ALIAS
Rituximab	Drug	Rituximab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Single Arm
description
This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of Measurable Residual Disease (MRD) adapted duration of BR for untreated or R/R iNHL (indolent non-hodgkin lymphoma). All patients will receive Bendamustine 90 mg/m2 IV on Days 1-2 and Rituximab 375 mg/m2 IV(BR) on Day 1 of each cycle. Each cycle will last 28 days. On day 1 of each cycle, patients will receive Rituximab before Bendamustine, and CBC (complete blood count), CMP (comprehensive metabolic panel) will be obtained to capture any hematologic toxicities as well as clonoSEQ testing to determine MRD status. After completing Cycle 3, imaging results (with confirmatory biopsy if applicable) and the clonoSEQ MRD testing results obtained from ctDNA (blood collection) will determine whether patients will receive Cycles 5 and 6 of Bendamustine and Rituximab (BR).
interventionNames
1. Drug: Bendamustine
2. Drug: Rituximab

Primary outcomes (2)

measure
PFS Evaluation
timeFrame
2 years
description
To evaluate the 2-year progression free survival (PFS) for patients treated with Bendamustine and Rituximab (BR) with measurable residual disease directed (MRD) duration of therapy.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 99 Years

Show eligibility criteria text

Inclusion Criteria:

Patients must have pathologically confirmed:

* indolent Non-Hodgkin Lymphoma, consistent with one of the below diagnoses:
* Follicular Lymphoma (Grade 1-3a)
* Marginal Zone Lymphoma
* Lymphoplasmacytic Lymphoma

Patient may be treatment naïve or relapsed/refractory without having received prior Bendamustine or patients recently started on Bendamustine 90 mg/m2 with Rituximab 375 mg/m2 are eligible if C2D1 BR is no more than 14 days prior to enrollment and they otherwise meet eligibility criteria

* Age \> 18 years
* ECOG performance status 0-2

Patients must have normal organ and marrow function as defined below:

* Absolute Neutrophil Count \>1000mm3 and Hemoglobin \>8 g/dL (unless due to bone marrow involvement by lymphoma)
* Total bilirubin \> 1.5x upper limit of normal (patients with Gilbert's syndrome can have total bilirubin up to 3x upper normal limit)
* Aspartate aminotransferase/ alanine aminotransferase (serum glutamic-oxaloacetic transaminase/ serum glutamic-pyruvic transaminase) \< 5 times institutional normal limits
* Creatinine clearance \> 30 Ml/min

Exclusion Criteria:

* Radiation or systemic treatment for lymphoma within the past 28 days prior to cycle 1 day 1 of BR.
* Patients with pathologically confirmed transformed lymphoma, including diffuse large B cell lymphoma or other high grade lymphomas
* Patients on active treatment for second malignancy with the exception of endocrine therapy for non-metastatic breast cancer, hormone therapy for prostate cancer, or local treatment for non-melanoma skin cancer.
* Pregnant or breast-feeding. Refer to section 5.4 for further detail.
* Failure to identify a dominant clonal sequence with ClonoSEQ from pre-treatment specimen or inadequate tissue for testing

References

Publications (0)

Data not yet available

No reference posted for this study.