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Non-Hodgkin's LymphomaPhase 1/2NCT01585688

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

A Phase 1/2 study testing hLL1-DOX (IMMU-115) in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hLL1-DOX (IMMU-115)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
6 sitesUnited States
Study dates
Aug 2012to Oct 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • --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)

Who cannot join

  • -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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • IU Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • U.T. MD Anderson Cancer Center Houston

    Houston, Texas, 77030

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • UMass Memorial Cancer Center of Excellence

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
hLL1-DOX (IMMU-115)
Keywords
NHL, CLL
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hLL1-DOX (IMMU-115)Drug

    Also called 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.

Study groups in NCT01585688
Study groupRoleWhat they receive
hLL1-DOXExperimentalNot described
Receives: Drug: hLL1-DOX (IMMU-115)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety and tolerability of hLL1-DOX

    NCI CTCAE version 4.0 is used to grade all adverse events

    Measured: These assessments will be done routinely during treatment & changes at 4, 8 & 12 weeks after treatment

  2. All patients who were treated and meet the efficacy criteria for response assessment will be included in the analysis of efficacy

    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.

    Measured: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionNov 2016
  4. Study completionOct 2017

Why it stopped: Study was terminated due to lack of efficacy, as a result, the stability program for the drug product was discontinued

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585688
Sponsor's protocol ID
IM-T-hLL1-DOX-02
Status last verified
Feb 2020
First submitted
23 Apr 2012
Last updated
8 Oct 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing hLL1-DOX (IMMU-115) in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to lack of efficacy, as a result, the stability program for the drug product was discontinued). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.

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