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PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia (CLL)

Thank you

Trial Information

PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB


Inclusion Criteria:



- Must be >/= 18 years old and able to provide consent

- Must have diagnosis of CLL as defined by NCI criteria

- Must require chemotherapy

- Must be previously treated with a minimum of one course of prior chemo or other
treatment

- Serum creatinine <1.8 mg/dl

- Bilirubin must be
- Must have adequate liver function (as defined as <2x ULN, unless related to CLL)

- AST/ALT <2x ULN

- Performance status 0-2

- Women of child bearing age must be willing to use accepted/effective method of birth
control.

Exclusion Criteria:

- Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.

- Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia

- Not have history of corticosteroid treatment for CLL

- Not have CNS disease

- Not have clinically significant infections

- Patients with a second malignancy, other than basal cell carcinoma of the skin or in
situ carcinoma of the cervix are not eligible.

- Not have positive serology for Hepatitis B or Hepatitis C

- Not have be known to be HIV positive

- Not have New York Classification III or IV hear disease

Other protocol specific criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate/ Efficacy

Outcome Description:

The primary objective for this trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.

Safety Issue:

No

Principal Investigator

Mark Kirschbaum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nevada Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

NVCI 09-15

NCT ID:

NCT01131247

Start Date:

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • CLL
  • bendamustine
  • ofatumumab
  • blood cancer
  • leukemia
  • lymphoma
  • lymphocyte
  • refractory
  • Advanced
  • relapsed
  • hematologic
  • hematology
  • antibody
  • non-Hodgkin lymphoma
  • small lymphocytic lymphoma
  • nevada cancer institute
  • cephalon
  • Glaxosmithkline
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Mayo ClinicScottsdale, Arizona