Clinical trial NCT02046928: Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 2 Trial to Determine the Safety, Tolerability, and Efficacy of A6, a CD44 Binding Peptide, for the Treatment of Patients With Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
CLL
SLL
Keywords: Leukemia
Lymphoma
Lead sponsor: Ångstrom Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).

Detailed description: In patients diagnosed with CLL or SLL, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CLL or SLL based on IWCLL Criteria
* Measurable or evaluable disease based on IWCLL criteria
* Previously untreated patients who have been counseled on approved alternative therapeutic options. Not a candidate for fludarabine/cyclophosphamide/rituximab (FCR) or has preference to not receive chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) status of 0-2.
* Adequate bone marrow, renal, liver, cardiac and pulmonary function.
* Life expectancy of greater than or equal to 6 months.

Exclusion Criteria:

* Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
* Receipt of corticosteroids \> 20 mg/day within 4 weeks prior to1st dose
* Major surgery or radiation within 4 weeks prior to 1st dose
* Presence of uncontrolled infection requiring systemic therapy
* Active second malignancy other than non-melanoma skin cancer
* Uncontrolled autoimmune anemia or thrombocytopenia
* Receipt of any investigational agent within 4 weeks prior to 1st dose
* Pregnant or lactating female
* Any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.

Primary outcomes:
measure: Overall response rate
timeFrame: Assessed at Day 28 of Cycle 6
Secondary outcomes:
measure: Safety of A6
timeFrame: Throughout 6 Cycles (6 months)
measure: Determine IWCLL response rate in the Intent-To-Treat Population
timeFrame: Throughout 6 Cycles (6 months)
measure: Determine the response in patients who received all 6 cycles of A6
timeFrame: 6 months
measure: Determine progression-free survival
timeFrame: Throughout 6 Cycles (6 months)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center, UCSD
state: California
Study officials:
affiliation: Moores Cancer Center, UCSD
name: Michael Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: