Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cancer and Leukemia Group B.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00004857
First received: March 7, 2000
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Biological: alemtuzumab
Drug: fludarabine phosphate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Response [ Time Frame: 2 months post consolidation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 months post consolidation ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: January 2000
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fludarabine + Campath-1H
Standard of care induction with fludarabine followed by consolidation antibody therapy
Biological: alemtuzumab
30 mg subQ injection tiw for 6 weeks
Other Name: campath-1H
Drug: fludarabine phosphate
25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13

Detailed Description:

OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients.

OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS: Previously untreated, stage I, II, III, or IV B-cell chronic lymphocytic leukemia (CLL) Lymphocytosis greater than 5,000/mm3 with less than 55% prolymphocytes Bone marrow aspirate with greater than 30% of all nucleated cells being lymphoid OR Bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL Overall cellularity must be normocellular or hypercellular Monoclonal B-cell population positive for at least 1 B-lineage marker (CD19, CD20, CD23, CD24) with coexpression of CD5 Bright surface immunoglobulin levels must have CD23 coexpression Stage I or II disease must have evidence of active disease demonstrated by at least 1 of the following: Massive or progressive splenomegaly and/or lymphadenopathy Presence of weight loss greater than 10% over the preceding 6-month period Grade 2 or 3 fatigue Fevers greater than 100.5 degrees Fahrenheit or night sweats for greater than 2 weeks without evidence of infection Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Direct Coomb's test negative Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: Not pregnant or nursing Fertile patients must use effective contraception No medical condition requiring chronic oral corticosteroids

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for CLL No concurrent epoetin alfa Chemotherapy: No prior chemotherapy for CLL No other concurrent chemotherapy Endocrine therapy: No prior corticosteroids for autoimmune complications that have developed since initial diagnosis of CLL No concurrent hormones except steroids for new adrenal failure or nondisease-related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other corticosteroid-based antiemetics Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004857

  Show 50 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Kanti R. Rai, MD Long Island Jewish Medical Center
  More Information

Additional Information:
Publications:
Rai KR, Byrd JC, Peterson B: Subcutaneous alemtuzumab following fludarabine for previously untreated patients with chronic lymphocytic leukemia (CLL): CALGB study 19901. [Abstract] Blood 102 (11 Pt 1): A-2506, 2003.
Rai KR, Byrd JC, Peterson BL, et al.: A phase II trial of fludarabine followed by alemtuzumab (Campath-1H) in previously untreated chronic lymphocytic leukemia (CLL) patients with active disease: Cancer and Leukemia Group B (CALGB) study 19901. [Abstract] Blood 100 (11 Pt 1): A-772, 2002.
Morrison VA, Peterson BL, Rai KR, et al.: Alemtuzumab increases serious infections in patients with previously untreated chronic lymphocytic leukemia (CLL) receiving fludarabine-based therapy: a comparative analysis of 3 Cancer and Leukemia Group B studies (CALGB 9011, 9712, 19901). [Abstract] Blood 110 (11): A-756, 2007.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00004857     History of Changes
Other Study ID Numbers: CDR0000067506, U10CA031946, CLB-19901
Study First Received: March 7, 2000
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

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
Fludarabine
Fludarabine monophosphate
Alemtuzumab
Campath 1G
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014