Trial record 1 of 1 for:
NCT01088048
Study to Investigate 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
This study is currently recruiting participants.
Verified April 2012 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01088048
First received: March 12, 2010
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to evaluate the safety and clinical activity of CAL-101 in combination with CD20 mAb chemotherapeutic agents, mTOR inhibitors and proteasome inhibitor in patients with hematologic malignancies.
| Condition | Intervention | Phase |
|---|---|---|
|
Indolent Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma |
Drug: CAL-101 Drug: Rituximab Drug: Bendamustine Drug: Ofatumumab Drug: Fludarabine Drug: Everolimus Drug: Bortezomib Drug: Chlorambucil |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Chlorambucil
Bendamustine hydrochloride
Bendamustine
Fludarabine
Sirolimus
Fludarabine phosphate
Everolimus
Temsirolimus
Rituximab
Bortezomib
Ofatumumab
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- 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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical activity will be evaluated by clinical response rate - assessed by CT scan, clinical laboratory tests and bone marrow biopsy if indicated [ Time Frame: every 2-3 months ] [ Designated as safety issue: No ]
- Measure plasma concentrations of CAL-101 [ Time Frame: Every two weeks then as required per protocol ] [ Designated as safety issue: No ]
- Measure plasma concentrations of chemotherapeutic agents in a select subset of patients [ Time Frame: Every two weeks then as required per protocol ] [ Designated as safety issue: No ]
- To investigate the pharmacodynamic effects of CAL-101 treatment - assessed by comparing pre and post dose blood samples [ Time Frame: Every two weeks then as required per protocol ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 224 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rituximab + CAL-101
CAL-101 100 mg or 150 mg twice daily plus treatment with rituximab 375 mg/m2 for 8 weekly doses
|
Drug: CAL-101
100mg or 150 mg by mouth twice daily
Drug: Rituximab
375 mg/m2 administered intravenously
Other Name: Rituxan
|
|
Experimental: Rituximab + Bendamustine + CAL-101
CAL-101 150 mg twice daily plus rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1 & 2 of Cycles 1-6 for iNHL and MCL patients. Bendamustine 70 mg/m2 for CLL patients only.
|
Drug: CAL-101
100mg or 150 mg by mouth twice daily
Drug: Rituximab
375 mg/m2 administered intravenously
Other Name: Rituxan
Drug: Bendamustine
90 mg/m2 or 70 mg/m2 administered intravenously
Other Name: Treanda
|
|
Experimental: Bendamustine + CAL-101
CAL-101 100mg or 150mg twice daily plus bendamustine 90 mg/m2 or 70 mg/m2 on days 1 & 2 of Cycles 1-6.
|
Drug: CAL-101
100mg or 150 mg by mouth twice daily
Drug: Bendamustine
90 mg/m2 or 70 mg/m2 administered intravenously
Other Name: Treanda
|
|
Experimental: Ofatumumab + CAL-101
CAL-101 150mg BID daily plus 12 doses of ofatumumab over the course of 6 months. For patients with CLL only.
|
Drug: CAL-101
100mg or 150 mg by mouth twice daily
Drug: Ofatumumab
12 doses over 6 months administered intravenously.
Other Name: Arzerra
|
|
Experimental: Fludarabine + CAL-101
CAL-101 150 mg twice daily plus treatment with oral fludarabine 40mg/m2 on days 1 through 5 of Cycles 1-6. For patients with CLL only
|
Drug: Fludarabine
40mg/m2 taken orally on days 1 through 5 of Cycles 1-6
Other Name: Fludara
|
|
Experimental: Everolimus + CAL-101
CAL-101 150 mg twice daily plus treatment with oral Everolimus 10 mg QD. For patients with MCL only
|
Drug: Everolimus
10 mg QD taken orally until disease progression
Other Name: RAD-001
|
|
Experimental: Bortezomib + CAL-101
CAL-101 150 mg twice daily plus treatment with Bortezomib administered at a dose of 1.3 mg/m2 as a subcutaneous injection once weekly for 3 weeks (Days 1, 8, and 15) followed by a 13 day rest period. For patients with MCL only.
|
Drug: Bortezomib
Administered at a dose of of 1.3 mg/m2 as a subcutaneous injection once weekly for 3 weeks (Days 1, 8, and 15) followed by a 13-day rest period.
Other Names:
|
|
Experimental: Chlorambucil + CAL-101
CAL-101 150 mg twice daily plus treatment with Chlorambucil administered at a dose of 10 mg/m2 on days 1-7 every 28 days. For patients with CLL only.
|
Drug: Rituximab
375 mg/m2 administered intravenously
Other Name: Rituxan
Drug: Chlorambucil
Chlorambucil is administered at 10 mg/m2 on days 1-7 every 28 days to allow appropriate therapy for CLL patients and to coordinate into a cycle period equivalent to other study treatment regimens.
Other Name: Leukeran
|
|
Experimental: Rituximab + Chlorambucil + CAL-101
Rituximab 375 mg/m2 + Chlorambucil 10 mg/m2 + CAL-101 150 mg BID for CLL patients only
|
Drug: Chlorambucil
Chlorambucil is administered at 10 mg/m2 on days 1-7 every 28 days to allow appropriate therapy for CLL patients and to coordinate into a cycle period equivalent to other study treatment regimens.
Other Name: Leukeran
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088048
Locations
| United States, Alabama | |
| Clearview Cancer Institute | Recruiting |
| Huntsville, Alabama, United States, 35805 | |
| Contact: Kathy Cutter, RN, BSN 256-705-4248 KathyC@ccihsv.com | |
| Principal Investigator: Marshall T Schreeder, MD | |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Audrey Rogue-Tayag 310-998-4730 ARTayag@mednet.ucla.edu | |
| Principal Investigator: Sven De Vos, MD | |
| Stanford Cancer Center | Recruiting |
| Palo Alto, California, United States, 94304-5548 | |
| Contact: Michelle Takahashi 650-736-4032 mtakaha2@stanford.edu | |
| Principal Investigator: Steven Coutre, MD | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Natalie Bongiorno 301-571-2016 Nbongiorno@ccbdmd.com | |
| Principal Investigator: Ralph Boccia, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Kelly Righton 314-747-8084 KRIGHTON@dom.wustl.edu | |
| Principal Investigator: Nina Wagner-Johnston, MD | |
| United States, New York | |
| Long Island Jewish Medical Center | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Ireen Kahn IKahn@NSHS.edu | |
| Principal Investigator: Jacqueline Barrientos, MD | |
| Weill Medical College of Cornell | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Jenna Fogel 212-746-5269 jef2017@med.cornell.edu | |
| Principal Investigator: John Leonard, M.D. | |
| United States, Oregon | |
| Willamette Valley Cancer Institute and Research Center | Recruiting |
| Springfield, Oregon, United States, 97477 | |
| Contact: Jeanne Schaffer 541-521-8773 Jeanne.Schaffer@USOncology.com | |
| Principal Investigator: Jeff Sharman, MD | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Ask SARAH 877-MY-1-SCRI (691-7274) asksarah@scresearch.net | |
| Principal Investigator: Ian Flinn, MD | |
| United States, Texas | |
| MD Anderson Cancer | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Justin Cumming 713-792-8785 JJCummings@mdanderson.org | |
| Principal Investigator: Nathan Fowler, MD | |
| United States, Washington | |
| North Star Lodge Cancer Center | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Beth Parker 509-574-3493 beth.parker@yvmh.org | |
| Principal Investigator: Thomas Boyd, MD | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Langdon Miller, MD | Gilead Sciences |
More Information
No publications provided by Gilead Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01088048 History of Changes |
| Other Study ID Numbers: | 101-07 |
| Study First Received: | March 12, 2010 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
CLL NHL MCL Phosphatidylinositol 3-kinase Bendamustine CD20 mAb Rituximab CAL-101 |
Oftatumumab iNHL indolent NHL Fludarabine Everolimus Bortezomib Chlorambucil |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine |
Fludarabine Fludarabine monophosphate Rituximab Bortezomib Antineoplastic Agents Chlorambucil Nitrogen Mustard Compounds Sirolimus Everolimus Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013