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

Condition(s) targeted: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma

Intervention: CAL-101 (Drug); Rituximab (Drug); Bendamustine (Drug); Ofatumumab (Drug); Fludarabine (Drug); Everolimus (Drug); Bortezomib (Drug); Chlorambucil (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Langdon Miller, MD, Study Director, Affiliation: Gilead Sciences

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.

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

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

Primary outcome: 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

Secondary outcome:

Clinical activity will be evaluated by clinical response rate - assessed by CT scan, clinical laboratory tests and bone marrow biopsy if indicated

Measure plasma concentrations of CAL-101

Measure plasma concentrations of chemotherapeutic agents in a select subset of patients

To investigate the pharmacodynamic effects of CAL-101 treatment - assessed by comparing pre and post dose blood samples

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Clearview Cancer Institute, Huntsville, Alabama 35805, United States; Recruiting
Kathy Cutter, RN, BSN, Phone: 256-705-4248, Email: KathyC@ccihsv.com
Marshall T Schreeder, MD, Principal Investigator

UCLA, Los Angeles, California 90024, United States; Recruiting
Audrey Rogue-Tayag, Phone: 310-998-4730, Email: ARTayag@mednet.ucla.edu
Sven De Vos, MD, Principal Investigator

Stanford Cancer Center, Palo Alto, California 94304-5548, United States; Recruiting
Michelle Takahashi, Phone: 650-736-4032, Email: mtakaha2@stanford.edu
Steven Coutre, MD, Principal Investigator

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States; Recruiting
Natalie Bongiorno, Phone: 301-571-2016, Email: Nbongiorno@ccbdmd.com
Ralph Boccia, MD, Principal Investigator

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Kelly Righton, Phone: 314-747-8084, Email: KRIGHTON@dom.wustl.edu
Nina Wagner-Johnston, MD, Principal Investigator

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States; Recruiting
Ireen Kahn, Email: IKahn@NSHS.edu
Jacqueline Barrientos, MD, Principal Investigator

Weill Medical College of Cornell, New York, New York 10021, United States; Recruiting
Jenna Fogel, Phone: 212-746-5269, Email: jef2017@med.cornell.edu
John Leonard, M.D., Principal Investigator

Willamette Valley Cancer Institute and Research Center, Springfield, Oregon 97477, United States; Recruiting
Jeanne Schaffer, Phone: 541-521-8773, Email: Jeanne.Schaffer@USOncology.com
Jeff Sharman, MD, Principal Investigator

Sarah Cannon Research Institute, Nashville, Tennessee 37203, United States; Recruiting
Ask SARAH, Phone: 877-MY-1-SCRI (691-7274), Email: asksarah@scresearch.net
Ian Flinn, MD, Principal Investigator

MD Anderson Cancer, Houston, Texas 77030, United States; Recruiting
Justin Cumming, Phone: 713-792-8785, Email: JJCummings@mdanderson.org
Nathan Fowler, MD, Principal Investigator

North Star Lodge Cancer Center, Yakima, Washington 98902, United States; Recruiting
Beth Parker, Phone: 509-574-3493, Email: beth.parker@yvmh.org
Thomas Boyd, MD, Principal Investigator

Starting date: March 2010
Last updated: April 18, 2012