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| Name | Class |
|---|---|
| Adaptive Biotechnologies | INDUSTRY |
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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.
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.
All patients with untreated or R/R (not previously treated with Bendamustine) iNHL (Follicular Lymphoma (Grade 1-3a2), Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma) are candidates for this trial. Patients requiring treatment per treating physician's discretion are eligible for the trial.
Patients who recently started on and received two cycles of Bendamustine at 90 mg/m2 dose with Ritxumab 375 mg/m2 are also eligible for this trial. For these patients, C2D1 BR should be no more than 14 days prior to the time of study enrollment (i.e. enrollment no later than C2D14). Patients who have received two cycles of 90mg/m2 Bendamustine dose with Rituximab 375 mg/m2 can enter the study and initiate cycle 3 once pre-screening and screening procedures have been completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Bendamustine will be administered as 10 minute IV infusion at 90 mg/m2 (drug dose calculation is based on treatment day weight) on days 1 and 2 for 4-6 cycles (number of cycles determined per treatment design). Subjects will be dosed every 28 days. Ondansetron 16 mg IV is given as premedication per institutional guidelines. Dose modifications will be determined based on renal and hepatic function. Subjects should be carefully monitored for infusion reactions during Bendamustine administration. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Bendamustine may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment based on physician discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Evaluation | 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. | 2 years |
| Statistical PFS | The proportion (p) of patients who are progression-free and are alive at 2 years from the initiation of treatment using Lugano Criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure | Assess additional clinical outcomes including overall survival (OS), | 2 years |
| Measurable Residual Disease Evaluation | To determine the rate of MRD (minimal residual disease) negativity at end of treatment and at 2 years post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome Measures | Assess and compare measurable residual disease (MRD) sensitivity of both circulating tumor DNA (ctDNA) and circulating tumor cells (CTC), both being obtained at baseline, after each cycle, and during follow up | 2 years |
| Measurable Residual Disease (MRD) |
Inclusion Criteria:
Patients must have pathologically confirmed:
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
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abigail O'Keefe | Contact | 215-728-2451 | abigail.o'keefe@fccc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Messmer | Fox Chase Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| D012460 | Sulfasalazine |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Rituximab | Drug | Rituximab will be administered as an IV infusion at 375 mg/m2 (longer for the first dose) (drug dose calculation is based of treatment day weight) on day 1 for 4-6 cycles (number of cycles determined per treatment design). Infusion rate will be determined as per institutional standards. Subjects will be dosed every 28 days. Diphenhydramine 50 mg IV and acetaminophen 650 mg are required to be given to the subjects within 30 minutes prior to Rituximab dose. There are no dose modifications recommended with Rituximab. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Rituximab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment. |
|
|
| 2 years |
| Adverse Event assessment | Assess adverse effects of treatment | 2 years |
| Overall Survival Assessment | OS, defined as time from initiation of study treatment until death, or the end of follow-up, whichever occurs first. Patients who are still alive at the end of follow-up will be considered censored. | 2 years |
| Measurable Residual Disease Negativity | To evaluate MRD negativity rate at the end of treatment and at 2 years post-treatment. | 2 years |
| Rate of 3+ adverse events | The rate of grade 3+ adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.The rate of grade 3+ adverse events as assessed by CTCAE v5.0. | 2 years |
Assess MRD level, both ctDNA and circulating tumor cell (CTC) testing, after each cycle of Bendamustine and Rituximab (BR) and correlate with Progression Free Survival (PFS) |
| 2 years |
| Progression Free Survival (PFS) for Measurable Residual Disease (MRD) | To evaluate PFS for patients with low level detectable MRD (10^-4 to 10^-6) after 3 cycles of Bendamustine and Rituximab | 2 years |
| Measurable Residual Disease (MRD) to guide indolent lymphoma treatment evaluation | Evaluate feasibility of using MRD to guide treatment for indolent lymphoma | 2 years |
| Measurable Residual Disease (MRD) failure rate | Determine MRD test baseline failure rate from ctDNA and Circulating Tumor Cell (CTC) testing | 2 years |
| Infection occruance | Assess occurrence of infection of any grade | 2 years |
| Secondary malignancy occurrence | Assess occurrence of secondary malignancy | 2 years |
| Ntural Killer and T cell reconstitution | Assess the rate of NK (natural kiler) cell and T cell subset reconstitution after Bendamustine and Rituximab; distinguish if there is difference between shorter/longer treatment regimens | 2 years |
| Quality Life Assessment | Assess differences in quality of life based on Functional Assessment of Cancer Therapy (FACT-Lym) questionnaire between patients who received varying lengths of treatment. | 2 years |
| Baseline Proliferative Rate | Correlation of baseline proliferative rate | 2 years |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |