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A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy


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

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Trial Information

A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy


Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often
of the IgM class, can be detected in the serum and/or urine of most patients with CLL.
Unique cell surface markers are increasingly being used to diagnose the disease, and in
approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be
found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and
symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and
thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival
from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of
patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who
rarely die from the disease.

CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and
co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot
predict the prognosis in individual patients.


Inclusion Criteria:



- Male or female, at least 18 years old.

- Signed informed consent.

- Zubrod performance status of 0, 1, or 2 (Appendix C).

- Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical
complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents,
fludarabine or chemoimmunotherapy but have documentation of residual disease by
immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells
that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual
population of CD5 and CD19 positive cells that comprise <10% of the marrow
mononuclear cells and have a Kappa/Lambda ratio >6 or <.33.

- Patients with CLL who have achieved a partial remission (PR) or nodular partial
remission (nPR) by NCI-WG criteria after chemotherapy.

- Creatinine, bilirubin, AST or ALT and alkaline phosphatase ≤2 x the upper limit of
normal.

Exclusion Criteria:

- Active infection.

- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted
humanized monoclonal antibodies.

- Less than 2 months since prior chemotherapy.

- Previous treatment with CAMPATH-1H.

- Pregnant or nursing women.

- Patients on corticosteroids.

- Uncontrolled autoimmune hemolytic anemia.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate residual disease (documented by flow cytometry) or b) convert partial remission to complete remission

Outcome Time Frame:

Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death

Safety Issue:

No

Principal Investigator

Thomas Kipps, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director, Chronic Lymphocytic Leukemia Research Consortium

Authority:

United States: Food and Drug Administration

Study ID:

CRC005

NCT ID:

NCT00800943

Start Date:

December 2003

Completion Date:

August 2010

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Leukemia
  • Chronic
  • Chronic Lymphocytic Leukemia
  • CAMPATH
  • Alemtuzumab
  • MabCampath
  • Subcutaneous
  • CLL
  • C-CLL
  • Residual
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
University of California San DiegoLa Jolla, California  92093