Status and phase
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About
The purpose of this study is to find out what effects a new drug AT7519M has on chronic lymphocytic leukemia.
Full description
This research is being done because AT7519M has been shown to shrink tumours in animals, has been studied in a few people and seems promising, but it is not clear if it can offer better results than standard treatment.
Enrollment
Sex
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Volunteers
Inclusion criteria
Absolute lymphocyte count ≥ 10 x 10^9/L OR At least one pathologically enlarged lymph node (≥ 2 x 2 cm) by CT scan
Systemic Therapy:
Patients must have received at least one prior systemic treatment regimen (single agent or combination therapy). There is no limit on number of prior regimens.
Patients must be ≥ 4 weeks since last dose of systemic therapy (including investigational). Exceptions to the 4-week interval since last treatment are possible if prior therapy is non-myelosuppressive or if any treatment-related myelosuppression has resolved.
Rationale:
Based on a review of recently published phase II trials of CDK inhibitors in relapsed and refractory CLL, there does not appear to be sufficient grounds to restrict the number of previous cycles of systemic chemotherapy. The IND193 investigators do not predict that this change will affect either the safety or efficacy outcomes of the study drug.
Radiation:
Patients may have had radiation, provided a minimum of 21 days has elapsed prior to enrollment. (Exceptions may be made however, for low dose, palliative radiotherapy Patients must have recovered from any acute toxic effects from radiation prior to registration.
Surgery:
Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed if surgery was major.
Exclusion criteria
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, other in situ cancers or other invasive malignancies curatively treated with no evidence of disease for ≥ 5 years.
Patients with known CNS involvement by CLL. Tests to investigate CNS involvement are required only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings).
Patients with clinically suspected or proven progression to high grade lymphoma (Richter's transformation) or myelodysplasia.
Patients with known hypersensitivity to the study drug or its components.
The following are exclusions for enrolment on the study:
Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including, but not limited to:
Patients with pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction as follows:
Patients who are currently receiving treatment with agents with a known risk of Torsades de Pointes. (see http://torsades.org [list #1]). However, patients may be enrolled on study if treatment with such agents is stopped ≥ 7 days prior to first dose of AT7519M.
Patients with pre-existing peripheral neuropathy (sensory and/or pain) > grade 2.
Patients with uncontrolled auto-immune hemolytic anemia (AIHA) and/or auto-immune thrombocytopenia (ITP) who require active treatment.
Primary purpose
Allocation
Interventional model
Masking
7 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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