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

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ClinicalTrials.gov Identifier: NCT03133221
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Gilead Sciences
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
Jean A Yared, MD, University of Maryland

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
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 2021
Estimated Study Completion Date : March 2022


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03133221


Contacts
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Contact: Veronica Rodriguez, BS, CCRC (410) 328-9747 Veronica.Rodriguez@umm.edu
Contact: Carolynn G. Harris, MS, CCRP (410) 706-3758 charris@umm.edu

Locations
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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Monica Sumoza    305-243-8266    mks147@med.miami.edu   
Contact: Nathalie Luis, BS    305-243-7648    nluis@med.miami.edu   
Principal Investigator: Amer Beitinjaneh         
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201-1592
Contact: Patricia Lesho, BA    410-328-2577    plesho@umm.edu   
Contact: Carolynn G. Harris, BA, CCRP    410-328-8198    charris@umm.edu   
Principal Investigator: Jean Yared, MD         
Sub-Investigator: Aaron Rapoport, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Debra Pastorek, BS, RN    414-805-6837    dpastore@mcw.edu   
Contact: Michael Flood, BS    (414) 805-4628    mflood@mcw.edu   
Principal Investigator: Mehdi Hamadani, MD         
Sponsors and Collaborators
University of Maryland
Gilead Sciences
University of Miami Sylvester Comprehensive Cancer Center
Investigators
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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, Assistant Professor of Medicine, University of Maryland
ClinicalTrials.gov Identifier: NCT03133221     History of Changes
Other Study ID Numbers: HP-00072715; 1630GCC
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
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:
NHL
indolent NHL
Zydelig
Idelalisib
B-cell NHL
Non-Hodgkin Lymphoma
Maintenance
Transformed B-cell Non-Hodgkin's lymphoma
Autologous Stem Cell Transplantation

Additional relevant MeSH terms:
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Idelalisib
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action