Status:
COMPLETED
NOX-A12 in Combination With Bendamustine and Rituximab in Relapsed Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
TME Pharma AG
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously treated patients with...
Detailed Description
CLL cells express high levels of CXCR4 chemokine receptors, which cause leukemia cell migration and adhesion to stromal cells secreting the CXCR4 ligand, CXCL12 (or stromal-derived-factor 1, SDF-1). N...
Eligibility Criteria
Inclusion
- Diagnosis of B-cell CLL
- Relapsed, bendamustine-sensitive (at least partial response with a duration of at least six months) or bendamustine-naive patients after at least one but not more than 3 prior treatments of their disease.
- CLL in need of treatment (Binet C or A/B with active disease) according to Hallek et al. 2008
- Subject must have measurable disease according to NCI-WG criteria (for details see Hallek M, Blood 2008; 111: 5446-5456).
- Pre-study WHO performance status ≤ 2 and modified cumulative illness rating score (CIRS) of less than 7.
- Signed, written informed consent.
- Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment.
- Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN) at screening, AST (SGOT) and/or ALT (SGPT) ≤ 2.5 x ULN.
- Acceptable hematologic status: Platelet count ≥ 75 x 109/L, ANC \> 0.75x109/L.
- Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance (Cockroft-Gault Formula) ≥ 50 mL/min
- Male or female, age ≥ 18
- No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.
Exclusion
- Relapse of B-cell CLL within 12 months after last chemotherapy.
- Subjects who have progressed to more aggressive B-cell cancers such as Richter's syndrome.
- CLL with documented loss of the short arm of chromosome 17 (17p-) associated with the loss of p53.
- The subject has a history of or is clinically suspicious for cancer-related Central Nervous System disease.
- Patients at risk of hemostasis or spleen rupture.
- Autoimmune hemolytic anemia.
- Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for allo SCT as assessed by their treating physician
- Patient has a history of other active malignancies within three years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
- The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
- Female subject is pregnant or breast-feeding.
- Known infection with HIV, active Hepatitis B or Hepatitis C.
- The patient has a history of prior toxicity from bendamustine or rituximab that resulted in permanent discontinuation of treatments.
- Treatment with other investigational drugs, or participation in another clinical trial within 30 days prior to study drug administration.
- Uncontrolled hypertension (defined as systolic blood pressure (BP) \> 160 mm Hg or diastolic BP \> 100 mm Hg).
- Myocardial infarction or unstable angina within the past 6 months prior to study drug administration.
- Systemic illnesses or other severe concurrent disease including alcoholism which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
- Known or suspected of not being able to comply with the trial protocol.
- Having been previously enrolled in this clinical trial.
- Known hypersensitivity to rituximab or to any of the excipients or to murine proteins
- History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infection.
- Known hypersensitivity to bendamustine or to mannitol.
- Invasive surgery within 30 days prior to study drug administration.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01486797
Start Date
March 1 2012
End Date
April 1 2017
Last Update
May 22 2017
Active Locations (17)
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1
Medical University Innsbruck, Division of Hematology and Oncology
Innsbruck, Austria
2
University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology
Salzburg, Austria
3
Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology)
Steyr, Austria
4
Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology)
Wels, Austria