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A Phase I/II Study of Immunotherapy With hLL1-DOX in Patients With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Phase I/II Study of Immunotherapy With hLL1-DOX in Patients With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Patients receive hLL1-DOX at one of 4 dose levels administered on Days 1, 4, 8 and 11 of
21-day treatment cycles which are continued in the absence of progression or unacceptable
toxicity up to a total of 8 cycles. After treatment, follow-up will be done at 4, 8 and 12
weeks post-treatment and will continue to be done every 3 months for up to 2 years.

Inclusion Criteria:

- 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
-Adequate cardiac function (MUGA scan or 2-D ECHO with LVEF ≥ 55%, EKG with no medically
relevant arrhythmia uncontrolled on medications)

Exclusion Criteria:

- -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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Safety will be measured by physical examinations and hematology and chemistry blood tests. Cardiac safety will be done using MUGA scans or echocardiograms. These assessments will be done routinely during treatment and again 4, 8 and 12 weeks after treatment. Long term safety will be assessed every 3 months after that for up to 2 years.

Outcome Time Frame:

during treatment and the change at 4, 8 & 12 weeks after treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

February 2017

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • NHL
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin



MD Anderson Cancer Center Orlando Orlando, Florida  32806
Helen F. Graham Cancer Center Newark, Delaware  19713
IU Health Goshen Center for Cancer Care Goshen, Indiana  46526
John Theurer Cancer Center Hackensack University Medical Center Hackensack, New Jersey  07601
UMass Memorial Cancer Center of Excellence Worcester, Massachusetts  01605
U.T. MD Anderson Cancer Center Houston Houston, Texas  77030