B-cell Non-Hodgkin LymphomaPhase 1/2DI-Leu16-IL2NCT01874288
A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL
A Phase 1/2 study testing DI-Leu16-IL2 in people with B-cell Non-Hodgkin Lymphoma, run by Alopexx Oncology, LLC at 5 sites in United States.
Trial summary
This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma
- What is being tested?
- DI-Leu16-IL2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Nov 2013to 16 Nov 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants with CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy. Chronic lymphocytic leukemia/small lymphocytic lymphoma with peripheral blood leukemia/lymphoma cells and high-grade lymphomas are excluded.
- Participants must have received prior rituximab-containing therapy.
- Evaluable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable.
- Participants who have received a prior autologous stem cell transplant are eligible if the transplant occurred >6 months ago.
- Participants who have received a prior allogeneic stem cell transplant are eligible if:
- The transplant occurred >6 months ago
Show all 25Show fewer
- There is no evidence of active graft versus host disease
- Systemic immunosuppressive agents (including corticosteroids) have not been received for at least 8 weeks
- Karnofsky performance scale ≥70%
- Life expectancy ≥12 weeks
- Adequate baseline functions:
- Serum creatinine ≤1.5 mg/deciliter (dL)
- Total white blood cell (WBC) count ≥3000/microliter (µL) or absolute neutrophil count (ANC) ≥1000/µL
- Absolute lymphocyte count ≥0.75 * 10^3/µL
- Platelet count ≥75,000/µL
- Hematocrit ≥25% or hemoglobin ≥9 grams/100 milliliters (mL)
- Alanine aminotransferase (ALT) <2.5 * upper limit of normal (ULN)
- Aspartate aminotransferase (AST) <2.5 * ULN
- Total bilirubin (TBili) <1.5 * ULN
- Sodium, potassium, and phosphorus levels no worse than grade 1
- Chest x-ray (CXR) or computed tomography (CT) within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema. If results are questionable, participants should have additional lung function testing to exclude clinically relevant restriction or obstruction. Participants must have a forced expiratory volume (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) of at least 65% and 50% of expected, respectively.
- Electrocardiogram (12-lead ECG) QTc ≤480 millisecond (ms)
- Cardiac stress test (for example, stress thallium scan, stress echocardiography) with normal results if participant is suspected to have coronary artery disease.
- Participants participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months).
- Provide written informed consent prior to any screening procedures
Who cannot join
- Evidence of central nervous system lymphoma or lymphomatous meningitis
- Prior treatment with interleukin 2 (IL2) within the last 5 years
- 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 and human immunodeficiency virus or other conditions), or clinical evidence of these conditions
Show all 19Show fewer
- Actively infected with or chronic carriers of hepatitis B virus as demonstrated by positive hepatitis B core antibody or hepatitis B surface antigen. Participants who are seropositive only, that is, surface antibody positive [HbsAb], are permitted.
- Other significant active infection.
- Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
- Uncontrolled hypertension (diastolic greater to or equal to 100 millimeters of mercury [mmHg]) or hypotension (systolic less than or equal to 90 mmHg)
- History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias
- History of medically significant ascites requiring repetitive paracentesis
- Previous diagnosis of autoimmune disease (Exceptions: participants 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
- Participants with bulky lymph nodes (LNs) (≥10 centimeters [cm]) or marked splenomegaly (that is, extending into pelvis or crossing the midline).
- Circulating levels of rituximab >75.0 micrograms (µg)/mL
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
City of Hope
Duarte, California, 91010
St. Jude Hospital Yorba Linda
Fullerton, California, 92835
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Joe Arlington Cancer Research and Treatment Center
Lubbock, Texas, 97410
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma (NHL)
This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.
Read the detailed description
The participants will be enrolled during dose escalation and during 2 expansion cohorts of up to 12 participants each.
The dose escalation portion of the trial will incorporate a modified accelerated titration design. Therefore, the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study (skipping every other dose level). Once the first instance of any Grade 3 or higher treatment related toxicity (with some notable exceptions) is observed on the first cycle, the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants (standard 3+3 design), with single step 2 milligrams (mg)/square meter (m^2) increments.
To further explore the clinical efficacy, additional participants (up to 12 per cohort) may be enrolled at the optimal biologic dose (OBD) or maximum tolerated dose (MTD).
At the end of the study, participants may be enrolled into an open-label extension study (AO-101-EXT [NCT02151903]), at the discretion of the investigator.
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Being tested
- DI-Leu16-IL2
- Keywords
- NHL, Immunocytokine, Lymphoma, Non-Hodgkin, B-cell, IL (interleukin)
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DI-Leu16-IL2Drug
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| DI-Leu16-IL2 0.5 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 0.5 mg/m^2 subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. Receives: Drug: DI-Leu16-IL2 |
| DI-Leu16-IL2 1.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. Receives: Drug: DI-Leu16-IL2 |
| DI-Leu16-IL2 2.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. Receives: Drug: DI-Leu16-IL2 |
| DI-Leu16-IL2 4.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles Receives: Drug: DI-Leu16-IL2 |
| DI-Leu16-IL2 6.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. Receives: Drug: DI-Leu16-IL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of DI-Leu16-IL2
The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Measured: First 2 cycles of treatment (each cycle = 21 days)
Number of Participants With a DLT
All non-hematologic AEs and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included ALC Grade 3 and 4 (if ALC does not resolve to baseline grade according to CTCAE v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and ANC Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Measured: First 2 cycles of treatment (each cycle = 21 days)
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1) Disappearance of all detectable clinical and radiological evidence of disease; 2) lymph nodes (LN) regressed to normal size; 3) other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4) clear bone marrow (BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 cm in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.
Measured: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 6 months)
Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Measured: Baseline, end of study (EOS) (up to approximately 3 years)
Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Measured: Baseline, EOS (up to approximately 3 years)
Secondary outcomes (1)
Number of Participants With Anti-DI-Leu16-IL2 Antibodies
Measured: First dose of study drug up to EOS (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study start25 Nov 2013
- Primary completion27 Jan 2014
- Study completion16 Nov 2016
Why it stopped: Clinical benefit was noted in the earlier portion of the trial; hence, participants were not enrolled in 2 expansion cohorts and the study was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alopexx Oncology, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Vlock, MD, Study director, Alopexx Oncology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874288
- Sponsor's protocol ID
- AO-101
- Acronym
- DI-Leu16-IL2
- Status last verified
- Nov 2020
- First submitted
- 7 Jun 2013
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
King DM, Albertini MR, Schalch H, Hank JA, Gan J, Surfus J, Mahvi D, Schiller JH, Warner T, Kim K, Eickhoff J, Kendra K, Reisfeld R, Gillies SD, Sondel P. Phase I clinical trial of the immunocytokine EMD 273063 in melanoma patients. J Clin Oncol. 2004 Nov 15;22(22):4463-73. doi: 10.1200/JCO.2004.11.035. Epub 2004 Oct 13.
PubMed 15483010Ko YJ, Bubley GJ, Weber R, Redfern C, Gold DP, Finke L, Kovar A, Dahl T, Gillies SD. Safety, pharmacokinetics, and biological pharmacodynamics of the immunocytokine EMD 273066 (huKS-IL2): results of a phase I trial in patients with prostate cancer. J Immunother. 2004 May-Jun;27(3):232-9. doi: 10.1097/00002371-200405000-00008.
PubMed 15076141Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, Levy R. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994 Oct 15;84(8):2457-66.
PubMed 7522629
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT01874288
- Acronym / sponsor ID
- DI-Leu16-IL2 / AO-101
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Keywords
- NHL, Immunocytokine, Lymphoma, Non-Hodgkin, B-cell, IL (interleukin)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical benefit was noted in the earlier portion of the trial; hence, participants were not enrolled in 2 expansion cohorts and the study was terminated early.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alopexx Oncology, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 27 Jan 2014 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.
Detailed description
The participants will be enrolled during dose escalation and during 2 expansion cohorts of up to 12 participants each.
The dose escalation portion of the trial will incorporate a modified accelerated titration design. Therefore, the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study (skipping every other dose level). Once the first instance of any Grade 3 or higher treatment related toxicity (with some notable exceptions) is observed on the first cycle, the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants (standard 3+3 design), with single step 2 milligrams (mg)/square meter (m^2) increments.
To further explore the clinical efficacy, additional participants (up to 12 per cohort) may be enrolled at the optimal biologic dose (OBD) or maximum tolerated dose (MTD).
At the end of the study, participants may be enrolled into an open-label extension study (AO-101-EXT [NCT02151903]), at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DI-Leu16-IL2 0.5 mg/m^2 | Experimental | Drug: DI-Leu16-IL2Participants will receive DI-Leu16-IL2 0.5 mg/m^2 subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. |
| DI-Leu16-IL2 1.0 mg/m^2 | Experimental | Drug: DI-Leu16-IL2Participants will receive DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. |
| DI-Leu16-IL2 2.0 mg/m^2 | Experimental | Drug: DI-Leu16-IL2Participants will receive DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. |
| DI-Leu16-IL2 4.0 mg/m^2 | Experimental | Drug: DI-Leu16-IL2Participants will receive DI-Leu16-IL2 4.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles |
| DI-Leu16-IL2 6.0 mg/m^2 | Experimental | Drug: DI-Leu16-IL2Participants will receive DI-Leu16-IL2 6.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants with CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy. Chronic lymphocytic leukemia/small lymphocytic lymphoma with peripheral blood leukemia/lymphoma cells and high-grade lymphomas are excluded.
- Participants must have received prior rituximab-containing therapy.
- Evaluable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable.
- Participants who have received a prior autologous stem cell transplant are eligible if the transplant occurred >6 months ago.
- Participants who have received a prior allogeneic stem cell transplant are eligible if:
Key exclusion criteria (19 listed)
- Evidence of central nervous system lymphoma or lymphomatous meningitis
- Prior treatment with interleukin 2 (IL2) within the last 5 years
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DI-Leu16-IL2DI-Leu16-IL2 will be administered per dose and schedule specified in the arm. | Drug | DI-Leu16-IL2 0.5 mg/m^2, DI-Leu16-IL2 1.0 mg/m^2, DI-Leu16-IL2 2.0 mg/m^2, DI-Leu16-IL2 4.0 mg/m^2, DI-Leu16-IL2 6.0 mg/m^2 |
Primary outcome
Maximum Tolerated Dose (MTD) of DI-Leu16-IL2
Time frame: First 2 cycles of treatment (each cycle = 21 days)
The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Number of Participants With a DLT
Time frame: First 2 cycles of treatment (each cycle = 21 days)
All non-hematologic AEs and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included ALC Grade 3 and 4 (if ALC does not resolve to baseline grade according to CTCAE v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and ANC Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
Time frame: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 6 months)
BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1) Disappearance of all detectable clinical and radiological evidence of disease; 2) lymph nodes (LN) regressed to normal size; 3) other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4) clear bone marrow (BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 cm in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.
Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
Time frame: Baseline, end of study (EOS) (up to approximately 3 years)
Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
Time frame: Baseline, EOS (up to approximately 3 years)
Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
1 secondary outcome
Number of Participants With Anti-DI-Leu16-IL2 Antibodies
Time frame: First dose of study drug up to EOS (up to approximately 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15483010King DM, Albertini MR, Schalch H, Hank JA, Gan J, Surfus J, Mahvi D, Schiller JH, Warner T, Kim K, Eickhoff J, Kendra K, Reisfeld R, Gillies SD, Sondel P. Phase I clinical trial of the immunocytokine EMD 273063 in melanoma patients. J Clin Oncol. 2004 Nov 15;22(22):4463-73. doi: 10.1200/JCO.2004.11.035. Epub 2004 Oct 13.
- Background: PubMed 15076141Ko YJ, Bubley GJ, Weber R, Redfern C, Gold DP, Finke L, Kovar A, Dahl T, Gillies SD. Safety, pharmacokinetics, and biological pharmacodynamics of the immunocytokine EMD 273066 (huKS-IL2): results of a phase I trial in patients with prostate cancer. J Immunother. 2004 May-Jun;27(3):232-9. doi: 10.1097/00002371-200405000-00008.
- Background: PubMed 7522629Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, Levy R. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994 Oct 15;84(8):2457-66.
- Sponsor websiteLink provided by the sponsor.
- National Cancer Institute at the National Institute of HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Vlock, MD study director
Alopexx Oncology, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DI-Leu16-IL2 in people with B-cell Non-Hodgkin Lymphoma, run by Alopexx Oncology, LLC at 5 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 25 inclusion and 19 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (MTD) of DI-Leu16-IL2 (time frame: First 2 cycles of treatment (each cycle = 21 days)). The study lists 5 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 NCT01874288, which also lists 3 linked publications.
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 24 Nov 2020.