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1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation

1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance

NCT03133221•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This is a pilot study to learn how safe and how effective the study drug Zydelig works, after autologous stem cell transplant as a maintenance therapy in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).

Detailed Description

This pilot study is focused on maintenance Zydelig for patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL) after autologous stem cell transplantation. Oral Zydelig at 150 mg (or adjusted dose) twice daily continuously on 28-day cycles. Patients will continue on Zydelig up to one year or to progression/relapse/death or unacceptable toxicity, whichever occurs first.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically documented (by HPI or pathology report) iNHL as defined by follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma/Waldenstrom disease (LPL/WM) and small lymphocytic lymphoma (SLL) or tiNHL as defined by large B cell transformation of any of the above entities including chronic lymphocytic leukemia (CLL)
•2. Patients must be eligible to undergo high dose chemotherapy (HDT) followed by ASCT as a form of remission consolidation
•3. Patients without evidence of documented disease progression clinically or radiographically after ASCT (stable disease (SD), partial remission (PR) or complete remission (CR)) who have had count recovery (ANC \> 500, non-transfused platelet count \> 20,000) and are at least 30 days post ASCT but no more than 120 days post ASCT
•4. Patients may have received any prior therapy deemed necessary for them to be eligible to HDT/ASCT except for patients whom have progressed while on Zydelig. Patients who have responded to Zydelig previously are eligible for enrollment on the protocol.
•5. Age \>18
•6. ECOG performance status \<4
•7. Life expectancy of greater than four months.
•8. Patients must have normal organ function as defined below (after the HDT/ASCT):
•* total bilirubin less than 2x institutional upper limit of normal
•* AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
+3 more criteria

Exclusion Criteria

•1. Patients who have had chemotherapy or radiotherapy within 2 weeks of first dose of Zydelig.
•2. Patients receiving any other investigational agents within 30 days of receiving Zydelig
•3. Patients who were previously exposed to Zydelig and experienced progression of disease.
•4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Zydelig.
•5. Patients with active and/or untreated CNS lymphoma will not be eligible.
•6. Patients with inflammatory bowel disease.
•7. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection (defined as requiring systemic antibiotic treatment and fever within 48 hours of screening), symptomatic congestive heart failure (patients with NYHA score of III and above are excluded), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•8. Women who are pregnant or nursing or plan to become pregnant or nurse during the course of the study.
•9. Positive HIV status.
•10. Patients with lack of count recovery as defined in Protocol 3.1.1.1.1.
+9 more criteria

Locations (3)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

October 23, 2017

Primary Completion Date

June 15, 2023

Completion Date

September 29, 2024

Last Updated

June 27, 2025

Enrollment

ACTUAL participants

Conditions

Non Hodgkin LymphomaFollicular LymphomaIndolent LymphomaB-cell LymphomaTransformed LymphomaMarginal Zone LymphomaWaldenstrom MacroglobulinemiaSmall Lymphocytic LymphomaLymphoplasmacytic Lymphoma

Interventions

Zydelig

DRUG

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RECRUITINGPHASE2

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Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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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: June 27, 2025Data 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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1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

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Odronextamab in Low Tumor Volume Advanced FL