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

NCT00800943 | Unknown Phase 2 DMC

• 1 other identifier: CRC005
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

Leukemia; Chronic; Chronic Lymphocytic Leukemia; CAMPATH; Alemtuzumab; MabCampath; Subcutaneous; CLL; C-CLL; Residual

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (2)

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

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

• 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.

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

Study Arms (1)

Campath-1H

EXPERIMENTAL

Biological: Alemtuzumab (Campath-1H)

Interventions

Alemtuzumab (Campath-1H) BIOLOGICAL

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

Campath-1H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chronic Lymphocytic Leukemia Research Consortium: lead
• Bayer: collaborator

Study Sites (3)

University of California San Diego

La Jolla, California, 92093, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Bronchiolitis Obliterans Syndrome

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas Kipps, MD, PhD

  Director, Chronic Lymphocytic Leukemia Research Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2003
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 3, 2008

Record last verified: 2008-12

Locations

US (3)