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Anaplastic Large Cell LymphomaPhase 1NCT00720135

Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

A Phase 1 study testing DI-Leu16-IL2 immunocytokine, rituximab and flow cytometry in people with Anaplastic Large Cell Lymphoma and Cutaneous B-cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
DI-Leu16-IL2 immunocytokine, rituximab and flow cytometry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
17 Mar 2008to 1 Jul 2014
Phase
Phase 1
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with CD20-expressing B cell NHL that is relapsed or refractory to standard therapy; CLL/SLL with peripheral blood leukemia/lymphoma cells and high-grade lymphomas (i.e., lymphoblastic lymphoma/Burkitt lymphoma) are excluded
  • Patients must have received prior Rituxan
  • Measurable disease; in the absence of lymphadenopathy, splenomegaly with defects or measurable extramedullary disease is acceptable; however, bone marrow involvement alone will not be included in the study
  • Age >=18 years and <=65 physiologic years of age
  • KPS >= 70%
  • Life expectancy >= 12 weeks
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  • Serum creatinine =< 1.5 mg/dl
  • Total WBC >= 3000/ul or absolute neutrophil count (ANC) >= 1000/ul
  • Lymphocyte count >= 0.2 x 10^3/ul
  • Platelet count >= 75,000/ul
  • Hematocrit >= 25% or hemoglobin >= 9 g/100 ml
  • Alanine aminotransferase (ALT) =< 2.5 x UNL
  • Aspartate aminotransferase (AST) =< 2.5 x UNL
  • Total bilirubin (TBili) < 1.5 x UNL
  • Sodium, potassium, and phosphorus within normal limits
  • Chest x ray (CXR) within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema; if results are questionable, subjects would have additional lung function testing to exclude clinically relevant restriction or obstruction; subjects must have an FEV-1 and DLCO of at least 65% and 50% of expected, respectively
  • Electrocardiogram (12-lead ECG)
  • Echocardiogram (or MUGA) with normal left ventricular function
  • Cardiac stress test (e.g., stress thallium scan, stress echocardiography) with normal results if subject is suspected to have coronary artery disease
  • Fasting blood glucose (FBG) < 160 and hemoglobin (Hgb) A1C < 7% for subjects with diabetes mellitus (DM) or borderline DM
  • Women of procreative potential must have negative pregnancy test within the 2-week screening phase prior to Cycle 1, and all subjects of procreative potential must use adequate birth control throughout the study; subjects of procreative potential are defined as any fertile male, and any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy) or is not post-menopausal, defined as age-related amenorrhea >= 12 months
  • Provide written informed consent prior to any screening procedures

Who cannot join

  • Evidence of CNS lymphoma or lymphomatous meningitis
  • Prior treatment with IL-2
  • Type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusion of rituximab
  • Pregnant or lactating female
  • An immediate need for palliative radiotherapy or systemic corticosteroid therapy
  • Known intercurrent infections (including hepatitis C virus [HCV] and HIV or other conditions), or clinical evidence of these conditions
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  • Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcHb) or hepatitis B surface antigen (HbsAg); (subjects who are sero-positive only, i.e., surface antibody positive [HbsAg], are permitted)
  • Other significant active infection
  • Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
  • Uncontrolled hypertension (diastolic >= 100 mmHg) or hypotension (systolic =< 90 mmHg)
  • History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias
  • On ECG: a marked baseline prolongation of QT/QTc interval (> grade 2 QTc interval > 470 milliseconds)
  • History of medically significant ascites requiring repetitive paracentesis
  • Previous diagnosis of Addison's disease
  • Previous diagnosis of autoimmune disease (exceptions: subjects with autoimmune thyroiditis or vitiligo may be enrolled)
  • Organ transplant recipient
  • History of prior therapy or a serious, uncontrolled medical disorder that in the investigator's opinion would impair participation in the study
  • Known hypersensitivity to Tween-80 or human immunoglobulin
  • Legal incapacity or limited legal capacity
  • Patients with bulky lymph nodes (>= 10cm) or marked splenomegaly (i.e., extending into pelvis or crossing the midline)
  • Positive anti-DI-Leu16-IL2 antibody assay (where positive is defined as > 10% of the radiolabeled DI-Leu16-IL2 reactive with the subject's serum)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma

RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) of DI-Leu16-IL2 (DI-Leu16-IL2 immunocytokine) following peripheral blood B cell depletion with rituximab in patients with B-cell NHL.

II. To investigate the optimal biological dose (OBD) of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL, which may differ from the MTD.

III. To describe the toxicities associated with the proposed DI-Leu16-IL2 regimen.

SECONDARY OBJECTIVES:

  1. To evaluate the immunogenicity as measured by the induction of DI-Leu16-IL2-specific antibodies.

II. To evaluate the pharmacokinetics of DI-Leu16-IL2. III. To document any clinical responses associated with the proposed therapy and survival endpoints of the enrolled patients.

OUTLINE: This is a dose-escalation study of DI-Leu16-IL2 immunocytokine.

Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays.

Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays.

Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 5 years.

Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Waldenstrom Macroglobulinemia

What participants receive

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

  • DI-Leu16-IL2 immunocytokineBiological

    Also called de-immunized anti-CD20-IL-2 immunocytokine DI-Leu16-IL-2, DI-Leu16-IL-2

    Given IV

  • rituximabBiological

    Also called C2B8 Monoclonal Antibody, IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera

    Given IV

  • flow cytometryOther

    Correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • enzyme-linked immunosorbent assayOther

    Also called ELISA

    Correlative studies

  • reverse transcriptase-polymerase chain reactionGenetic

    Also called RT-PCR

    Correlative studies

Study groups in NCT00720135
Study groupRoleWhat they receive
Arm IExperimentalPatients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays. Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays. Treatment repeats every 6-8 weeks for up to a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: DI-Leu16-IL2 immunocytokine; Biological: rituximab; Other: flow cytometry; Other: immunohistochemistry staining method; Other: pharmacological study; Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Genetic: reverse transcriptase-polymerase chain reaction

What is being measured

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

  1. Maximum tolerated dose of DI-Leu16-IL2

    Measured: 6 weeks post cycle 1 of treatment

  2. Optimal biologic dose of DI-Leu16-IL2

    Measured: 6 weeks after final cycle of treatment

  3. Toxicities associated with the DI-Leu16-IL2 regimen

    Measured: 6 weeks after final cycle of treatment

Secondary outcomes (3)

  1. Immunogenicity as a result of DI-Leu16-IL2 administration

    Measured: Within 2 weeks following a 4 week treatment period

  2. Pharmacokinetics of DI-Leu16-IL2 administration

    Measured: 6 weeks after final cycle of treatment

  3. Clinical responses and survival

    Measured: Within two weeks following completion of treatment

Timeline

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

  1. First posted22 Jul 2008 (estimated)
  2. Study start17 Mar 2008
  3. Primary completion1 Jul 2014
  4. Study completion1 Jul 2014

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720135
Sponsor's protocol ID
03131
Other IDs
NCI-2010-01228, CDR0000598679, P50CA107399
Status last verified
Oct 2026
First submitted
19 Jul 2008
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DI-Leu16-IL2 immunocytokine, rituximab and flow cytometry in people with Anaplastic Large Cell Lymphoma and Cutaneous B-cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site 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 22 inclusion and 21 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of DI-Leu16-IL2 (time frame: 6 weeks post cycle 1 of treatment). The study lists 3 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 NCT00720135.

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 23 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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