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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01088048
• Date of registration: 12/03/2010
• Primary sponsor: Gilead Sciences
• Public title: 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
• Scientific 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
• Date of first enrolment: March 2010
• Target sample size: 224
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01088048
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Langdon Miller, MD
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia

Indolent Non-Hodgkin's Lymphoma

Mantle Cell Lymphoma

Intervention(s)

Drug: Bendamustine

Drug: Bortezomib

Drug: CAL-101

Drug: Chlorambucil

Drug: Everolimus

Drug: Fludarabine

Drug: Ofatumumab

Drug: Rituximab

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Measure plasma concentrations of CAL-101 [Time Frame: Every two weeks then as required per protocol]

Measure plasma concentrations of chemotherapeutic agents in a select subset of patients [Time Frame: Every two weeks then as required per protocol]

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]

Secondary ID(s)

101-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors