Acute Lymphoblastic LeukemiaPhase 2NCT00276159
Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
A Phase 2 study testing 852A in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma
- What is being tested?
- 852A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2008
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
- acute lymphoblastic leukemia (ALL)
- acute myeloid leukemia (AML)
- non-Hodgkin's lymphoma (NHL)
- Hodgkin's lymphoma (HL)
- multiple myeloma (MM)
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- chronic lymphocytic leukemia (CLL)
- Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
- Normal organ function within 14 days of study entry
- If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
Who cannot join
- Had/have the following prior/concurrent therapy:
- Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
- Investigational drugs/agents within 14 days of first dose of 852A
- Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
- Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions
- Radiotherapy within 4 weeks of the first dose of 852A
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- Hematopoietic cell transplantation 4 weeks of first dose of 852A
- Active infection or fever > 38.5°C within 3 days of first dose of 852A
- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- Uncontrolled intercurrent or chronic illness
- Active autoimmune disease requiring immunosuppressive therapy within 30 days
- Active hepatitis B or C with evidence of ongoing viral replication
- Hyperthyroidism
- Uncontrolled seizure disorder
- Active coagulation disorder not controlled with medication
- Pregnant or lactating
- Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated
- Proven active central nervous system (CNS) disease
- Human Immunodeficiency Virus (HIV) positive
- Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
Read the detailed description
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
- Being tested
- 852A
- Keywords
- Leukemia, Lymphoma, Myeloma, Hematology, 852A, IRM, Oncology
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
852ADrug
Also called Molecule 852A, S-32865
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| 852A Treatment | Experimental | Patients receiving at least one dose of 852A. Receives: Drug: 852A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.
Measured: Up to Week 12
Secondary outcomes (3)
Number of Patients Who Received Steroids
Number of patients who received steroids allowing successful continuation of therapy.
Measured: Up to Week 12
Measure of Immune Activation With Correlative Laboratory Studies
Measured: Up to Week 12
Peak Concentrations of 852A
Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Drug was not available.
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.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Sarah Cooley, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276159
- Sponsor's protocol ID
- 05US02IMP-852A
- Other IDs
- MT2005-20, 2005LS057, 0509M73467
- Status last verified
- Aug 2019
- First submitted
- 11 Jan 2006
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
- ClinicalTrials.gov ID
- NCT00276159
- Acronym / sponsor ID
- 05US02IMP-852A
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, Lymphoma, Myeloma, Hematology, 852A, IRM, Oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug was not available.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Posted 5 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
Detailed description
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 852A Treatment | Experimental | Drug: 852APatients receiving at least one dose of 852A. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
- Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
- Normal organ function within 14 days of study entry
- If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
Key exclusion criteria (21 listed)
- Had/have the following prior/concurrent therapy:
- Active infection or fever > 38.5°C within 3 days of first dose of 852A
- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- Uncontrolled intercurrent or chronic illness
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 |
|---|---|---|
| 852AAlso: Molecule 852A, S-32865Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2. | Drug | 852A Treatment |
Primary outcome
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Time frame: Up to Week 12
Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.
3 secondary outcomes
Number of Patients Who Received Steroids
Time frame: Up to Week 12
Measure of Immune Activation With Correlative Laboratory Studies
Time frame: Up to Week 12
Peak Concentrations of 852A
Time frame: Up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Cooley, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 852A in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota 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 10 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: stopped early, as of the sponsor's last update on 4 Sep 2019. 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 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 5 May 2010). 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?
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors (time frame: Up to Week 12). 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 4 Sep 2019.