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A Phase I Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Chemotherapeutic Agents and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Indolent Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma

Thank you

Trial Information

A Phase I Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Chemotherapeutic Agents and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Age ≥ 18

- Previously treated with relapsed or refractory disease (refractory defined as not
responding to a standard regimen or progressing within 6 month of the last course of
a standard regimen)

- WHO performance status of ≤ 2

Exclusion Criteria

- Is not a good candidate according to the clinical judgment of the investigator

- Patients with atypical immunophenotype with t(11:14) translocation or cyclin D1
over-expression (CLL patients only)

- Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment
with an investigational product within 4-weeks prior to the baseline disease status
tests

- Had treatment with a short course of corticosteroids for symptom relief within 1-week
prior to the baseline tests

- Has had an allogeneic hematopoietic stem cell transplant

- Has known active central nervous system involvement of the malignancy

- Is pregnant or nursing

- Has active, serious infection requiring systemic therapy.

- Has a positive test for human immunodeficiency virus (HIV) antibodies

- Has active hepatitis B or C. Patients with serologic evidence of prior exposure are
eligible.

- Has Child-Pugh Class B or C hepatic impairment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of CAL-101 in combination with CD20 mAb and chemotherapeutic agents, mTOR inhibitors, proteasome inhibitor in patients with hematologic malignancies - assessed by adverse events, vital signs, clinical laboratory tests and ECG

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Langdon Miller, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

101-07

NCT ID:

NCT01088048

Start Date:

March 2010

Completion Date:

October 2015

Related Keywords:

  • Indolent Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • CLL
  • NHL
  • MCL
  • Phosphatidylinositol 3-kinase
  • Bendamustine
  • CD20 mAb
  • Rituximab
  • CAL-101
  • Oftatumumab
  • iNHL
  • indolent NHL
  • Fludarabine
  • Everolimus
  • Bortezomib
  • Chlorambucil
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Stanford Cancer CenterStanford, California  94305-5824
North Star Lodge Cancer CenterYakima, Washington  98902
UCLALos Angeles, California  90095
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Clearview Cancer InstituteHuntsville, Alabama  35805
Sarah Cannon Research InstituteNashville, Tennessee  37203
Weill Medical College of CornellNew York, New York  10021
MD Anderson CancerHouston, Texas  77030
Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477