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

Primary Purpose

B-Cell Chronic Lymphocytic Leukemia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alemtuzumab (Campath-1H)
Sponsored by
Chronic Lymphocytic Leukemia Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Chronic Lymphocytic Leukemia focused on measuring Leukemia, Chronic, Chronic Lymphocytic Leukemia, CAMPATH, Alemtuzumab, MabCampath, Subcutaneous, CLL, C-CLL, Residual

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • M. D. Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Campath-1H

Arm Description

Outcomes

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 1, 2008
Last Updated
December 2, 2008
Sponsor
Chronic Lymphocytic Leukemia Research Consortium
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00800943
Brief Title
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy
Acronym
CRC005
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chronic Lymphocytic Leukemia Research Consortium
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Chronic Lymphocytic Leukemia
Keywords
Leukemia, Chronic, Chronic Lymphocytic Leukemia, CAMPATH, Alemtuzumab, MabCampath, Subcutaneous, CLL, C-CLL, Residual

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Campath-1H
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Alemtuzumab (Campath-1H)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kipps, MD, PhD
Organizational Affiliation
Director, Chronic Lymphocytic Leukemia Research Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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

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