Non Hodgkin LymphomaPhase 2NCT03133221
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
A Phase 2 study testing Zydelig in people with Non Hodgkin Lymphoma and Follicular Lymphoma, run by University of Maryland, Baltimore at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Follicular Lymphoma, Indolent Lymphoma
- What is being tested?
- Zydelig
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2017to 29 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- 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.
- Patients with active hepatic disease, liver cirrhosis, or known HBV/HCV infection.
- Patients with de novo diffuse large B-cell lymphoma.
- Patients with h/o PCP pneumonia or CMV infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201-1592
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance
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).
Read the 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.
- Conditions
- Non Hodgkin Lymphoma, Follicular Lymphoma, Indolent Lymphoma, B-cell Lymphoma, Transformed Lymphoma, Marginal Zone Lymphoma
- Being tested
- Zydelig
- Keywords
- NHL, indolent NHL, Zydelig, Idelalisib, B-cell NHL, Non-Hodgkin Lymphoma, Maintenance, Transformed B-cell Non-Hodgkin's lymphoma, Autologous Stem Cell Transplantation
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZydeligDrug
Also called Idelalisib
Zydelig given at 150mg continuously in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zydelig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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; Progression-free survival is defined as time from the date of autologous stem cell transplantation to progression, relapse and death, whichever comes first.
Measured: 1- and 2-year Progression-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start23 Oct 2017
- Primary completion15 Jun 2023
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, University of Miami Sylvester Comprehensive Cancer Center
- Responsible party
- Principal investigator, Jean A Yared, MD, University of Maryland, Baltimore
- Investigators
- Jean Yared, MD, Principal investigator, University of Maryland Greenebaum Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133221
- Sponsor's protocol ID
- HP-00072715; 1630GCC
- Status last verified
- Jun 2025
- First submitted
- 13 Apr 2017
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance
- ClinicalTrials.gov ID
- NCT03133221
- Acronym / sponsor ID
- HP-00072715; 1630GCC
- Conditions
- Non Hodgkin Lymphoma, Follicular Lymphoma, Indolent Lymphoma, B-cell Lymphoma, Transformed Lymphoma, Marginal Zone Lymphoma
- Keywords
- NHL, indolent NHL, Zydelig, Idelalisib, B-cell NHL, Non-Hodgkin Lymphoma, Maintenance, Transformed B-cell Non-Hodgkin's lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Gilead Sciences, University of Miami Sylvester Comprehensive Cancer Center
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Zydelig 150 mg BID | Experimental | Drug: ZydeligZydelig 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZydeligAlso: IdelalisibZydelig given at 150mg continuously in 28-day cycles | Drug | Oral Zydelig 150 mg BID |
Primary outcome
Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year
Time frame: 1 year.
The proportion of patients who discontinued the study due to Zydelig-related adverse events.
1 secondary outcome
Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
Time frame: 1- and 2-year Progression-free survival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Yared, MD principal investigator
University of Maryland Greenebaum Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zydelig in people with Non Hodgkin Lymphoma and Follicular Lymphoma, run by University of Maryland, Baltimore at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.