Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Pharmacyclics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Small Lymphocytic Lymphoma; Lymphoma; Chronic Lymphocytic Leukemia; Leukemia

Treatments: Drug: motexafin gadolinium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00290004

PCYC-0223

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years old

• CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following:

  • Refractory disease: progressive disease while on therapy
  • Relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization

• ECOG performance status score of 0, 1, or 2

• Willing and able to provide written informed consent

Exclusion criteria

• Laboratory values of:

  • Platelet count < 30,000/µL
  • AST or ALT > 2 x ULN (upper limit of normal)
  • Total bilirubin > 2 x ULN
  • Creatinine > 2 mg/dL

• Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment

• Major surgery or hospitalization for a serious illness within the last 3 months

• Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)

• Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer

• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)