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

NCT03133221 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HP-00072715; 1630GCC
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Non Hodgkin Lymphoma; Follicular Lymphoma; Indolent Lymphoma; B-cell Lymphoma; Transformed Lymphoma; Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma

Keywords

NHL; indolent NHL; Zydelig; Idelalisib; B-cell NHL; Non-Hodgkin Lymphoma; Maintenance; Transformed B-cell Non-Hodgkin's lymphoma; Autologous Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year

  The proportion of patients who discontinued the study due to Zydelig-related adverse events.

  1 year.

Secondary Outcomes (1)

• Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.

  1- and 2-year Progression-free survival

Study Arms (1)

Oral Zydelig 150 mg BID

EXPERIMENTAL

Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.

Drug: Zydelig

Interventions

Zydelig DRUG

Zydelig given at 150mg continuously in 28-day cycles

Also known as: Idelalisib

Oral Zydelig 150 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients must be eligible to undergo high dose chemotherapy (HDT) followed by ASCT as a form of remission consolidation
• 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
• 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.
• Age \>18
• ECOG performance status \<4
• Life expectancy of greater than four months.
• 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
• Creatinine \< 1.5x institutional upper limit of normal OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels \> 1.5x upper limit of normal.
• Because the effects of Zydelig on the developing human fetus are unknown, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Participants must agree to use contraception for at least 30 days after the last dose of Zydelig. Women of childbearing potential is defined as women who continues to have menstrual periods, have not had a tubal ligation, or the removal of fallopian tubes, ovaries or uterus.
• Ability to understand English and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 2 weeks of first dose of Zydelig.
• Patients receiving any other investigational agents within 30 days of receiving Zydelig
• Patients who were previously exposed to Zydelig and experienced progression of disease.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Zydelig.
• Patients with active and/or untreated CNS lymphoma will not be eligible.
• Patients with inflammatory bowel disease.
• 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.
• Women who are pregnant or nursing or plan to become pregnant or nurse during the course of the study.
• Positive HIV status.
• Patients with lack of count recovery as defined in Protocol 3.1.1.1.1.
• Patients who are unable to swallow pills.
• Patients with moderate to severe lung disease including:
• Patients requiring O2 supplementation
• Patients unable to walk 50 feet without stopping to rest
• Moderate to severe obstructive or restrictive disease of the lung

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Gilead Sciences: collaborator
• University of Miami Sylvester Comprehensive Cancer Center: collaborator

Study Sites (3)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201-1592, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jean Yared, MD
• Organization: University of Maryland Greenebaum Comprehensive Cancer Center

jyared@umm.edu

410-328-1230

Study Officials

• Jean Yared, MD

  University of Maryland Greenebaum Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 28, 2017
• Study Start: October 23, 2017
• Primary Completion: June 15, 2023
• Study Completion: September 29, 2024
• Last Updated: June 27, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)