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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 Patients will be withdrawn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 Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Long Island Jewish Medical Center New Hyde Park, New York  11040
Moores UCSD Cancer Center La Jolla, California  92093-0658
Stanford Cancer Center Stanford, California  94305-5824
Oregon Health & Science University Portland, Oregon  97201
UCLA Los Angeles, California  90095
University of Wisconsin Madison,, Wisconsin  53792-5666
Clearview Cancer Institute Huntsville, Alabama  35805
The Ohio State University Medical Center Columbus, Ohio  43210
Sarah Cannon Research Institute Nashville, Tennessee  37203
Weill Medical College of Cornell New York, New York  10021
Willamette Valley Cancer Institute and Research Center Springfield, Oregon  97477
Center for Cancer & Blood Disorders, PC Bethesda, Maryland  20817
MD Anderson Cancer and Research Center Houston, Texas  77030
Yakima Regional Cancer Care Yakima, Washington  98902