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NCT03133221 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2025-06-27

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 * 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. 9. 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. 10. Ability to understand English and the willingness to sign a written informed consent document. 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. 11. Patients who are unable to swallow pills. 12. 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 13. Patients taking strong CYP3A4 inhibitors or inducers with Risk X (Avoid Combination) according to Lexicomp. Please see appendix C of the protocol for more information. 14. Patients with active hepatic disease, liver cirrhosis, or known HBV/HCV infection. 15. Patients with de novo diffuse large B-cell lymphoma. 16. Patients with h/o PCP pneumonia or CMV infection.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Zydelig
    label
    Oral Zydelig 150 mg BID
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Oral Zydelig 150 mg BID
    description
    Zydelig given at 150mg continuously in 28-day cycles
    name
    Zydelig
    other Names
    1. Idelalisib
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
17
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The proportion of patients who discontinued the study due to Zydelig-related adverse events.
    measure
    Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year
    time Frame
    1 year.
secondary Outcomes
  1. description
    1- and 2-year Progression-free survival; Progression-free survival is defined as time from the date of autologous stem cell transplantation to progression, relapse and death, whichever comes first.
    measure
    Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
    time Frame
    1- and 2-year Progression-free survival
Full study description
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).
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      primary nct id
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      payload
      clinical indication matching status
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      true
      id
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      link basis
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      nct id
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      occurrences
      1. context exact
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        exact text
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        start
        0
      offset unit
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      query cond
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      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice