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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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Obtain dose, safety, PK, and PD information about ALXN6000.

Outcome Time Frame:

From first dose through 10 weeks after the last dose

Safety Issue:

Yes

Principal Investigator

Leonard Heffner

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Food and Drug Administration

Study ID:

C07-003

NCT ID:

NCT00648739

Start Date:

June 2008

Completion Date:

November 2010

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • B-cell Chronic Lymphocytic Leukemia
  • Leukemia
  • Multiple Myeloma
  • CD200
  • Anti-CD200
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Duke University Medical CenterDurham, North Carolina  27710
Emory Winship Cancer InstituteAtlanta, Georgia  30322
Arizona Cancer Center at UMC NorthTucson, Arizona  85719
Hematology Oncology Assoc. of Northern NJ Carol G. Simon Cancer CenterMorristown, New Jersey  07962