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Single-agent CAL-101 for Previously Teated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma

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Trial Information

Single-agent CAL-101 for Previously Teated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events


This is a Phase 1/2, open-label, single-arm, efficacy, safety and pharmacodynamic study of
CAL-101 in patients with previously treated indolent Non-Hodgkin lymphoma.

Eligible patients will initiate oral therapy with CAL-101 at a starting dose of 150 mg twice
per day. Treatment with CAL-101 can continue in compliant patients for up to twelve 28-day
cycles of CAL-101. Patients who appear to be benefiting from treatment at the completion of
12 cycles of treatment with CAL-101 may be eligible for participation in a long-term safety
extension study of CAL-101.


Inclusion Criteria:



- Age ≥18.

- Previously treated low-grade (indolent) B-cell NHL.

- Measurable disease by CT scan, defined as at least 2 lesions that measure >1.5 cm in
a single dimension (one of which is superficial and easily accessible for biopsy).

- WHO performance status of ≤ 2.

- For men and women of child-bearing potential, willing to use adequate contraception
(i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire
duration of the study.

- Provide written informed consent.

Exclusion Criteria:

- Pregnant or nursing.

- Significant, ongoing co-morbid conditions which would preclude safe delivery of the
study drug.

- History of a transplant with current active graft-versus-host-disease.

- Known active central nervous system involvement of the malignancy.

- Active, serious infection requiring systemic therapy.

- Positive test for human immunodeficiency virus (HIV) antibodies.

- Active hepatitis B or C.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the overall safety of CAL-101

Outcome Description:

Safety will be evaluated by assessing extent of exposure to CAL-101, adverse events, clinical laboratory data, and vital signs

Outcome Time Frame:

Every 2-4 weeks

Safety Issue:

Yes

Principal Investigator

Joshua Brody, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

101-10

NCT ID:

NCT01306643

Start Date:

February 2011

Completion Date:

February 2013

Related Keywords:

  • Indolent Non-Hodgkin's Lymphoma
  • Follicular Lymphoma
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma
  • Indolent Non-Hodgkin's Lymphoma
  • Non-Hodgkin Lymphoma
  • iNHL
  • NHL
  • CAL-101
  • PI3K
  • Phosphatidylinositol 3-kinase
  • Follicular Lymphoma (FL)
  • Small Lymphocytic Lymphoma (SLL)
  • Marginal Zone Lymphoma (MZL)
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
Stanford Cancer CenterStanford, California  94305-5824