A Phase 1-2, Multicenter, Open-Label Study of AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas

Stopped early · Phase 1/Phase 2

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell

In brief

AEG35156 has shown early evidence of activity in patients with advanced indolent B-cell lymphomas in Phase 1 trials and merits further evaluation in this disease. This trial is designed to determine the recommended dose of AEG35156 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and indolent B-cell lymphomas.

Key facts

Study ID

NCT00768339

Run by

Aegera Therapeutics

People needed

25

Starts

2008-09-01

Expected to finish

2011-09-01

Last updated by the study team

2011-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an histologically confirmed diagnosis of CLL as per NCI-WG criteria or
• Patients with an histologically confirmed diagnosis of one of the following indolent B-cell lymphomas: (Follicular lymphoma (FL); Small lymphocytic lymphoma (SLL); Marginal zone lymphoma; Lymphoplasmacytic lymphoma)
• Relapsed or refractory patients who have failed at least 2 prior lines of therapy, one of which may have been high dose therapy and autologous stem cell transplantation. Steroids alone when used for autoimmune phenomena do not qualify as prior therapy
• ECOG performance less or equal than 2
• Life expectancy of at least 3 months
• Age greater or equal than 18 years
• Signed, written IRB-approved informed consent
• A negative serum pregnancy test (if applicable)
• Acceptable liver function:(Bilirubin within normal limit; AST (SGOT) and ALT (SGPT) less or equal than 2.5 x ULN or less or equal than 5 x ULN if there are liver lymphomatous involvement)
• Acceptable renal function: (Serum creatinine within normal limits, OR calculated creatinine clearance greater or equal than 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal)
• Acceptable hematologic status: (Granulocyte greater or equal than 1000 cells/uL; Platelet count greater or equal than 50,000 /uL)
• Acceptable coagulation status:(PT within normal limits; PTT within normal limits)
• For women of child-producing potential, the use of effective contraceptive methods during the study
• Prior radiotherapy for local disease is allowed provided disease progression has been documented, and treatment completed at least 4 weeks prior to registration

You may not qualify if…

• Uncontrolled autoimmune hemolysis and/or thrombocytopenia
• Richter's transformation
• Histologic transformation
• Patients with peripheral neuropathy
• Active progressive leptomeningeal disease including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of leptomeningeal disease to document the stability of prior lesions
• Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Known infection with HIV, hepatitis B, or hepatitis C
• Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
• Unwillingness or inability to comply with procedures required in this protocol

Where it is running

• Providence Saint-Joseph Medical Center — Burbank, California, United States
• New York Medical College — Valhalla, New York, United States
• The Cleveland Clinic, Taussig Cancer Institute — Cleveland, Ohio, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Jewish General Hospital - Sir Mortimer B. Davis — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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