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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03133221
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : April 22, 2022
Gilead Sciences
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
Jean A Yared, MD, University of Maryland, Baltimore

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).

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Follicular Lymphoma Indolent Lymphoma B-cell Lymphoma Transformed Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma Drug: Zydelig Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: Oral Zydelig 150 mg BID
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
Zydelig given at 150mg continuously in 28-day cycles
Other Name: Idelalisib

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Progression-free survival at 1 and 2 years after autologous stem cell transplantation. [ Time Frame: 1- and 2-year Progression-free survival ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03133221

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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1592
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Maryland, Baltimore
Gilead Sciences
University of Miami Sylvester Comprehensive Cancer Center
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Principal Investigator: Jean Yared, MD University of Maryland Greenebaum Comprehensive Cancer Center
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Responsible Party: Jean A Yared, MD, Associate Professor of Medicine, University of Maryland, Baltimore Identifier: NCT03133221    
Other Study ID Numbers: HP-00072715; 1630GCC
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean A Yared, MD, University of Maryland, Baltimore:
indolent NHL
B-cell NHL
Non-Hodgkin Lymphoma
Transformed B-cell Non-Hodgkin's lymphoma
Autologous Stem Cell Transplantation
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action