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An Extension Study to Investigate the Safety and Durability of Clinical Activity of CAL-101 in Patients With Hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Lymphoma, Non-Hodgkin, Acute Myeloid Leukemia, Multiple Myeloma

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Trial Information

An Extension Study to Investigate the Safety and Durability of Clinical Activity of CAL-101 in Patients With Hematologic Malignancies


This is a long-term safety extension study of idelilisib (CAL-101, GS-1101) in patients with
hematologic malignancies who complete other CAL-101 studies. Patients will be followed
according to the standard of care as appropriate for their type of cancer. The dose of
idelilisib (CAL-101, GS-1101) will generally be the same as the dose that was administered
at the end of the prior study, but may be titrated up to improve clinical response or down
for toxicity. Patients may receive other anti-cancer therapy. Patients will be withdrawn
from the study if they develop progressive disease, unacceptable toxicity related to
idelilisib (CAL-101, GS-1101), or if they no longer derive clinical benefit in the opinion
of the investigator.


Inclusion Criteria:



- Patients with hematologic malignancies completing a prior CAL-101 study with a
clinical benefit are eligible

Exclusion Criteria:

- No exclusion criteria

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Adverse events will be monitored at routine standard of care visits

Outcome Time Frame:

Approximately every 3 months

Safety Issue:

Yes

Principal Investigator

Thomas Jahn, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

101-99

NCT ID:

NCT01090414

Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lymphoma, Non-Hodgkin
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • idelilisib
  • CLL
  • NHL
  • AML
  • MM
  • Phosphatidylinositol 3-kinase
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Stanford Cancer CenterStanford, California  94305-5824
Oregon Health & Science UniversityPortland, Oregon  97201
UCLALos Angeles, California  90095
University of WisconsinMadison,, Wisconsin  53792-5666
Clearview Cancer InstituteHuntsville, Alabama  35805
The Ohio State University Medical CenterColumbus, Ohio  43210
Sarah Cannon Research InstituteNashville, Tennessee  37203
Weill Medical College of CornellNew York, New York  10021
Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477
Center for Cancer & Blood Disorders, PCBethesda, Maryland  20817
MD Anderson Cancer and Research CenterHouston, Texas  77030
Yakima Regional Cancer CareYakima, Washington  98902