Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648739
First received: March 28, 2008
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine the safety and best dose of ALXN6000 in treating relapsing or refractory B-CLL or MM and to study how ALXN6000 may help the immune system fight cancer.


Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Multiple Myeloma
Drug: ALXN6000
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Obtain dose, safety, PK, and PD information about ALXN6000. [ Time Frame: From first dose through 10 weeks after the last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Obtain biological information on ALXN6000 including binding to CD200 on B CLL cells; describe the effect of ALXN6000 in B-CLL patients on ORR and its components of CR, PR, nPR and SD; and in MM patients on response as defined in the protocol [ Time Frame: From first dose through 10 weeks after the last dose ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1, 2, 3, 4, 5, 6, and 7
ALXN6000 dose ranging cohorts numbered 1-7 with dosages of 50 mg/m2 to 600 mg/m2.
Drug: ALXN6000
Part A is a comparison of different dosages of ALXN6000 by cohort ranging from 50 mg/m2 up to 600 mg/m2 given as a single IV dose. Once the most appropriate dose is determined it will be given over a 28 day cycle for 4 cycles in Part B Cohort 1 = 50 mg/m2 Cohort 2 = 100 mg/m2 Cohort 3 = 200 mg/m2 Cohort 4 = 300 mg/m2 Cohort 5 = 400 mg/m2 Cohort 6 = 500 mg/m2

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsing or Refractory B CLL or MM
  • ECOG performance status 0-2
  • Anticipated survival of greater than 6 months.
  • Female patients of childbearing potential must agree to use two forms of contraception
  • Patients must have a standard indication for treatment of their malignancy
  • Is willing and able to give written informed consent.

Exclusion Criteria:

  • Absolute neutrophil count (ANC) < 1000 x 109/L
  • Platelet count < 50,000 x 109/L
  • Pregnant or lactating women.
  • Prior history of autoimmune hemolysis requiring therapy.
  • Prior history of immune thrombocytopenia.
  • Active autoimmune disease requiring immunosuppressive therapy.
  • Positive Coombs' Test (neither Direct or Indirect)
  • Ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
  • Prior stem cell transplantation within 4 weeks prior to enrollment.
  • Prior chemotherapy for the applicable malignancy within 30 days of enrollment.
  • Neurosurgery or cranial radiation therapy within one year of enrollment.
  • Clinically significant renal, hepatic or heart disease.
  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: NCT00648739

Locations
United States, Arizona
Arizona Cancer Center at UMC North
Tucson, Arizona, United States, 85719
United States, Georgia
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hematology Oncology Assoc. of Northern NJ Carol G. Simon Cancer Center
Morristown, New Jersey, United States, 07962
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Alexion Pharmaceuticals
Investigators
Principal Investigator: Leonard Heffner Emory University
Principal Investigator: Duruka Mahadevan University of Arizona College of Medicine
Principal Investigator: Charles Farber HOANNJ-Carol G. Simon Cancer Center
Principal Investigator: Moshe Talpaz University of Michigan Cancer Center
Principal Investigator: Mark Lanasa Duke University
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00648739     History of Changes
Other Study ID Numbers: C07-003
Study First Received: March 28, 2008
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexion Pharmaceuticals:
B-cell Chronic Lymphocytic Leukemia
Leukemia
Multiple Myeloma
CD200
Anti-CD200

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 22, 2014