Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

In brief

The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

Key facts

Study ID

NCT01585688

Run by

Gilead Sciences

People needed

13

Starts

2012-08-01

Expected to finish

2017-10-01

Last updated by the study team

2021-10-08

Who can join

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

You may qualify if…

• Male or female, age ≥ 18 years
• Able to provide signed, informed consent
• Histologically confirmed diagnosis of recurrent B-cell non-Hodgkin's lymphoma (any histology by WHO criteria) or recurrent chronic lymphocytic leukemia (by NCI criteria) (Reference Appendix C)
• Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
• Measurable disease at least one lesion ≥ 1.5 cm for NHL and ALC > 5,000 for CLL
• Adequate performance status (≥ 70 Karnofsky scale) with an estimated life expectancy of at least 6 months
• -Documented negative hepatitis B screen, per NCCN guidelines (hepatitis B surface antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen)
• At least 12 weeks beyond stem cell transplant and 4 weeks beyond chemotherapy or immunotherapy, major surgery, other experimental treatments, or radiation therapy to the index lesions, and with all acute toxicities from prior therapy resolved to less than Grade 2 toxicity by NCI CTC version 4.0
• Laboratory parameters:
• Adequate hematology without ongoing transfusional support Hemoglobin >/= 10 g/dL Absolute neutrophil count >/= 1.5 x 10 9/L Platelets >/= 75 x 10 9/L Creatinine and bilirubin </= 1.5 x IULN AST and ALT </= 2.5 x IULN
• Adequate cardiac function (MUGA scan or 2-D ECHO with LVEF ≥ 55%, EKG with no medically relevant arrhythmia uncontrolled on medications)

You may not qualify if…

• -Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
• Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
• Prior treatment with trastuzumab
• Bulky disease by CT, defined as any single mass > 10 cm in its greatest diameter
• Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
• New York Heart Classification III or IV heart disease (see Appendix G). Other severe cardiovascular or cardiopulmonary disease, including COPD
• Baseline BNP > 2 x IULN
• Patients with uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities will be excluded
• Patients with recent (≤ 6 months) cardiac angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias will be excluded
• Known autoimmune disease or presence of autoimmune phenomena
• At least 7 days beyond any infection requiring intravenous antibiotic use (Oral antibiotics may be administered prophylactically as clinically indicated)
• Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, ≤ 20 mg/day, or equivalent) which may continue if unchanged
• Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study

Where it is running

• Helen F. Graham Cancer Center — Newark, Delaware, United States
• MD Anderson Cancer Center Orlando — Orlando, Florida, United States
• IU Health Goshen Center for Cancer Care — Goshen, Indiana, United States
• UMass Memorial Cancer Center of Excellence — Worcester, Massachusetts, United States
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States
• U.T. MD Anderson Cancer Center Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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