Lymphoma, B-CellPhase 1NCT00538096
A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma
A Phase 1 study testing MEDI-538 in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by MedImmune LLC.
Trial summary
Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy. Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
- What is being tested?
- MEDI-538
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to May 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult men or women at least 18 years of age;
- Written informed consent and Heath Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the patient prior to performing any study-related procedures, including screening visits;
- Histologically confirmed B-cell NHL of one of the following classifications:
- Follicular lymphoma
- Marginal zone lymphoma;
- Lymphoplasmocytic lymphoma; or
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- Mantle cell lymphoma.
- Not eligible for curative therapy according to the NCCN guidelines for NHL (NCCN 2006);
- Measurable disease (at least one lesion ≥ 20 mm in one dimension) documented by computed tomography (CT) scan;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A);
- Life expectancy of at least 6 months;
- Heterosexual sexually active females, unless surgically sterile or at least 1 year postmenopausal, must use an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through 3 months after the last dose of MEDI-538. Cessation of birth control after this point should be discussed with a responsible physician. Heterosexual sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through 3 months after the last dose of MEDI-538;
- Hemoglobin ≥ 10.0 g/dL; absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelets ≥ 100.0 × 10^9/L; lymphocyte count ≥ 0.8 × 10^9/L; leukocyte count ≥ 3.0 × 10^9/L; and D-dimer ≤ 2.5 × upper limit of normal (ULN); and antithrombin III ≥ lower limit of normal (LLN); and 10. Total bilirubin ≤ 1.5 × ULN; aspartate transaminase (AST), alanine transaminase (ALT), amylase and lipase ≤ 2 × ULN; serum creatinine ≤ 2 × ULN, and creatinine clearance ≥ 50 mL/min.
Who cannot join
- Receipt of MEDI-538 in any previous clinical study;
- History of allergy or reaction to any component of the MEDI-538 formulation;
- Any other NHL not listed in inclusion criterion 3;
- History of malignancy other than B-cell NHL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy;
- Known or suspected CNS involvement by NHL;
- Clinical history of significant CNS pathology, eg, multiple occurrences of confusion, dementia, multiple previous infarcts, or major brain surgery;
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- Active infection or known bacteremia. Patients with documented evidence of culture positive sepsis or active infection requiring IV antibiotic therapy must complete a full course of antibiotic treatment with no clinical or laboratory evidence of bacterial infection at least 2 weeks prior to starting therapy with MEDI-538.
- Vaccination (either preventive or therapeutic for infectious disease or cancer) within 2 weeks prior to initiation of study drug;
- Infection with human immunodeficiency virus (HIV-1 or HIV-2), chronic infection with hepatitis B or C, or acute infection with hepatitis A;
- History of primary immunodeficiency;
- History of serious, chronic autoimmune disease, eg, rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis;
- Elective surgery planned during the study period through 30 days after discontinuation of MEDI-538;
- Autologous stem cell transplantation within 26 weeks prior to study entry;
- Allogenic stem cell transplantation or any other solid organ transplant;
- Cancer chemotherapy within 6 weeks prior to study entry;
- Radiotherapy within 6 weeks prior to study entry;
- Receipt of any investigational agent within 12 weeks prior to initiation of study drug;
- Treatment with rituximab within 12 weeks prior to study entry;
- Prior treatment with alemtuzumab;
- Regular dose of systemic corticosteroids during the 4 weeks prior to initiation of study drug or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry;
- Any contraindication to chronic anticoagulation with low-molecular weight heparin (LMWH);
- Inability for safe placement and prolonged use (at least 8 weeks) of a central venous catheter;
- Contraindication to any of the protocol-specified concomitant medications (methylprednisolone, antacids, or antihistamines) during this study;
- Presence of human anti-murine antibodies or known hypersensitivity to immunoglobulins;
- Pregnancy (sexually active females of childbearing potential must have a negative urine pregnancy test on the day of the first dose of the study drug, prior to dosing) or nursing;
- Evidence of any uncontrolled systemic disease (other than B-cell NHL), any finding upon physical examination or history of any disease that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
- Inability to meet social environment requirements for outpatient therapy (see Section 3.3.4.4).
About this study
Official title: A Phase I, Multicenter, Open-Label, Single-Arm, Dose-Escalation, Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of the Bispecific T-Cell Engager MEDI-538 in Adults With B-Cell Non-Hodgkin's Lymphoma Not Eligible for Curative Therapy
- Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
- Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.
Read the detailed description
- Evaluate the safety and tolerability of MEDI-538 at doses of 5, 10, or 15 μg/m2/24h by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for
- Determine the MTD of MEDI-538 administered by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
- Being tested
- MEDI-538
- Keywords
- B-cell Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-538Drug
1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
MEDI-538Drug
1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
MEDI-538Drug
1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-538 Receives: Drug: MEDI-538 |
| 2 | Experimental | MEDI-538 Receives: Drug: MEDI-538 |
| 3 | Experimental | MEDI-538 Receives: Drug: MEDI-538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All endpoints will be analyzed descriptively. AEs and SAEs will be summarized by dose cohort, body system, severity, and relationship to MEDI-538 through 30 days after discontinuation of MEDI-538.
Measured: 30 days after discontinuation of MEDI-538
Secondary outcomes (1)
The secondary endpoints of this study include measurement of the pharmacokinetics,immunogenicity, and antitumor activity of MEDI-538 in this patient population.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: Replacing this trial with a new trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen L. Kaucic, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538096
- Sponsor's protocol ID
- MI-CP137
- Status last verified
- Sep 2008
- First submitted
- 28 Sep 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-Label, Single-Arm, Dose-Escalation, Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of the Bispecific T-Cell Engager MEDI-538 in Adults With B-Cell Non-Hodgkin's Lymphoma Not Eligible for Curative Therapy
- ClinicalTrials.gov ID
- NCT00538096
- Acronym / sponsor ID
- MI-CP137
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
- Keywords
- B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replacing this trial with a new trial.
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
- Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.
Detailed description
- Evaluate the safety and tolerability of MEDI-538 at doses of 5, 10, or 15 μg/m2/24h by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for
- Determine the MTD of MEDI-538 administered by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-538MEDI-538 |
| 2 | Experimental | Drug: MEDI-538MEDI-538 |
| 3 | Experimental | Drug: MEDI-538MEDI-538 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adult men or women at least 18 years of age;
- Written informed consent and Heath Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the patient prior to performing any study-related procedures, including screening visits;
- Histologically confirmed B-cell NHL of one of the following classifications:
- Not eligible for curative therapy according to the NCCN guidelines for NHL (NCCN 2006);
- Measurable disease (at least one lesion ≥ 20 mm in one dimension) documented by computed tomography (CT) scan;
Key exclusion criteria (27 listed)
- Receipt of MEDI-538 in any previous clinical study;
- History of allergy or reaction to any component of the MEDI-538 formulation;
- Any other NHL not listed in inclusion criterion 3;
- History of malignancy other than B-cell NHL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy;
- Known or suspected CNS involvement by NHL;
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 |
|---|---|---|
| MEDI-5381 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment. | Drug | 1 |
| MEDI-5381 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment. | Drug | 2 |
| MEDI-5381 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment. | Drug | 3 |
Primary outcome
All endpoints will be analyzed descriptively. AEs and SAEs will be summarized by dose cohort, body system, severity, and relationship to MEDI-538 through 30 days after discontinuation of MEDI-538.
Time frame: 30 days after discontinuation of MEDI-538
1 secondary outcome
The secondary endpoints of this study include measurement of the pharmacokinetics,immunogenicity, and antitumor activity of MEDI-538 in this patient population.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
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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.
Karen L. Kaucic, M.D. study director
MedImmune LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-538 in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by MedImmune LLC.
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 13 inclusion and 27 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: withdrawn, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
All endpoints will be analyzed descriptively. AEs and SAEs will be summarized by dose cohort, body system, severity, and relationship to MEDI-538 through 30 days after discontinuation of MEDI-538. (time frame: 30 days after discontinuation of MEDI-538). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2008; AzTrials last refreshed its copy on 31 Oct 2026.