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
18 Years
N/A
Both
Indolent Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
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 Medicine | Saint Louis, Missouri 63110 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| North Star Lodge Cancer Center | Yakima, Washington 98902 |
| UCLA | Los Angeles, California 90095 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Clearview Cancer Institute | Huntsville, Alabama 35805 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Weill Medical College of Cornell | New York, New York 10021 |
| MD Anderson Cancer | Houston, Texas 77030 |
| Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
