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Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-Chronic Lymphocytic Leukemia

Thank you

Trial Information

Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)


Rationale: Research indicates that both cyclophosphamide and pentostatin work
synergistically against cancer cells and have a high response rate against chronic
lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition,
studies have shown that rituximab, a therapy that targets the immune system, has the highest
efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy
drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents
cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with
two promising chemotherapy agents against CLL.

Purpose: This study is evaluating the efficacy and safety of combination treatment with
cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating
the genetic and molecular components of CLL will also be performed. Some of these tests will
be conducted before, during, and after treatments to assess changes resulting from the study
drugs. Each patient's outcome will be assessed in relation to various aspects of their
genes.


Inclusion Criteria:



- Diagnosis of B-CLL (no mantle cell)

- Must have active disease

- Age >=18 yo

- ECOG 0-3

- No radiation or surgery <4 weeks

Exclusion Criteria:

- Any of the following comorbid conditions:

- New York Heart Association Class III or IV heart disease

- Recent myocardial infarction (<1 month)

- Uncontrolled infection

- Active infection with the human immunodeficiency virus (HIV/AIDS) as further
severe immunosuppression with this regimen may occur.

- Pregnant or nursing women

- Men or women of child bearing potential must use adequate contraception.

- Active primary malignancy requiring treatment or limits survival to ≤2 years.

- Any radiation therapy ≤4 weeks prior to study entry.

- Any major surgery ≤4 weeks prior to study entry.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.

Outcome Description:

For this evaluation, patients will be classified as complete responders if either of the following types of response are documented CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. CR denotes CCR and, in bone marrow, no nodules and <30% lymphocytes.

Outcome Time Frame:

up to 5 years

Safety Issue:

Yes

Principal Investigator

John Byrd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0143

NCT ID:

NCT00201721

Start Date:

July 2002

Completion Date:

November 2013

Related Keywords:

  • B-Chronic Lymphocytic Leukemia
  • Previously Untreated
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location
Ohio State University Columbus, Ohio  43210