Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy (CRC005)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Chronic Lymphocytic Leukemia Research Consortium.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Chronic Lymphocytic Leukemia Research Consortium
ClinicalTrials.gov Identifier:
NCT00800943
First received: December 1, 2008
Last updated: December 2, 2008
Last verified: December 2008
  Purpose

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

To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.


Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Biological: Alemtuzumab (Campath-1H)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chronic Lymphocytic Leukemia Research Consortium:

Primary Outcome Measures:
  • 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 [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry. [ 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. ] [ Designated as safety issue: No ]
  • To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR. [ 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. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2003
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath-1H Biological: Alemtuzumab (Campath-1H)
Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800943

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Chronic Lymphocytic Leukemia Research Consortium
Bayer
Investigators
Principal Investigator: Thomas Kipps, MD, PhD Director, Chronic Lymphocytic Leukemia Research Consortium
  More Information

No publications provided

Responsible Party: Thomas J. Kipps, M.D., Ph.D., University of California, San Diego, CLL Research Consortium
ClinicalTrials.gov Identifier: NCT00800943     History of Changes
Other Study ID Numbers: CRC005
Study First Received: December 1, 2008
Last Updated: December 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Chronic Lymphocytic Leukemia Research Consortium:
Leukemia
Chronic
Chronic Lymphocytic Leukemia
CAMPATH
Alemtuzumab
MabCampath
Subcutaneous
CLL
C-CLL
Residual

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014