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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585688
Recruitment Status : Terminated (Study was terminated due to lack of efficacy, as a result, the stability program for the drug product was discontinued)
First Posted : April 26, 2012
Last Update Posted : October 8, 2021
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Drug: hLL1-DOX (IMMU-115) Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Immunotherapy With hLL1-DOX in Patients With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : August 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: hLL1-DOX Drug: hLL1-DOX (IMMU-115)
hLL1-DOX is administered intravenously at one of 4 dose levels on days 1, 4, 8 and 11 of 21-day treatment cycles, with up to 8 cycles administered.
Other Name: IMMU-115

Primary Outcome Measures :
  1. Evaluate the safety and tolerability of hLL1-DOX [ Time Frame: These assessments will be done routinely during treatment & changes at 4, 8 & 12 weeks after treatment ]
    NCI CTCAE version 4.0 is used to grade all adverse events

  2. All patients who were treated and meet the efficacy criteria for response assessment will be included in the analysis of efficacy [ Time Frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years ]

    For the primary efficacy evaluations, the proportion of responders (defined as patients with a best response of PR or CR) will be tabulated for each dose level. In addition, the progression-free survival (PFS, as measured from start of treatment to disease progression, death or last follow-up) will be summarized using Kaplan-Meier survival analysis methods.

    Similarly, for responders at each dose level, the duration of response (DR, as measured from time of first response to relapse or last follow-up) will also be summarized using Kaplan- Meier survival analysis methods, if appropriate.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01585688

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United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Indiana
IU Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Massachusetts
UMass Memorial Cancer Center of Excellence
Worcester, Massachusetts, United States, 01605
United States, New Jersey
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Texas
U.T. MD Anderson Cancer Center Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Gilead Sciences
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Study Director: Pius P Maliakal, PhD Gilead Sciences
Study Chair: Francois Wilhelm, MD,PhD Gilead Sciences
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Responsible Party: Gilead Sciences Identifier: NCT01585688    
Other Study ID Numbers: IM-T-hLL1-DOX-02
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: February 2020
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes