LeukemiaPhase 1NCT00156299
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
A Phase 1 study testing choline magnesium trisalicylate and Dexamethasone in people with Leukemia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- choline magnesium trisalicylate and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia
- Newly diagnosed disease
- Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies
- Leukemic blast count > 5,000/mm³ of peripheral blood
- No acute promyelocytic leukemia (M3)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Bilirubin < 2.0 times upper limit of normal (ULN)
- AST < 3.0 times ULN
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
- No other concurrent medical condition that would preclude study compliance
- No allergies to any investigational drugs and/or chemotherapeutic agents
- No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy
- No clinical diagnosis of GI bleeding requiring blood transfusions
PRIOR CONCURRENT THERAPY:
- No prior induction therapy
- No prior chemotherapy for acute leukemia
- No concurrent medications that would preclude study compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate.
PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia.
- Determine toxicities of this regimen in these patients.
Secondary
- Determine patterns of leukemic cell gene expression in patients treated with this regimen.
- Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician.
Blood is collected at baseline, 24 hours, and 48 hours to assess for changes in NF-kB expression, apoptosis, and gene expression in leukemic cells.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- choline magnesium trisalicylate, Dexamethasone
- Keywords
- adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), untreated adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Erythroblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choline magnesium trisalicylateDrug
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
DexamethasoneDrug
10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone plus Choline Magnesium Trisalicylate | Experimental | Dexamethasone plus Choline Magnesium Trisalicylate Receives: Drug: choline magnesium trisalicylate; Drug: Dexamethasone |
| Choline Magnesium Trisalicylate | Experimental | Choline Magnesium Trisalicylate Receives: Drug: choline magnesium trisalicylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal changes in leukemic cell NF-kB activity
Measured: 5 years
Secondary outcomes (2)
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Measured: 5 years
Apoptosis related to NF-kB modulation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Replaced by another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roger Strair, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156299
- Sponsor's protocol ID
- CDR0000540303
- Other IDs
- P30CA072720, 020201
- Status last verified
- Nov 2013
- First submitted
- 8 Sep 2005
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Strair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8. doi: 10.1158/1078-0432.CCR-08-1390.
PubMed 19010875
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00156299
- Acronym / sponsor ID
- CDR0000540303
- Conditions
- Leukemia
- Keywords
- adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Replaced by another study
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Sep 2005 (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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate.
PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.
Detailed description
OBJECTIVES:
Primary
- Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia.
- Determine toxicities of this regimen in these patients.
Secondary
- Determine patterns of leukemic cell gene expression in patients treated with this regimen.
- Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician.
Blood is collected at baseline, 24 hours, and 48 hours to assess for changes in NF-kB expression, apoptosis, and gene expression in leukemic cells.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone plus Choline Magnesium Trisalicylate | Experimental | Drug: choline magnesium trisalicylate, Drug: DexamethasoneDexamethasone plus Choline Magnesium Trisalicylate |
| Choline Magnesium Trisalicylate | Experimental | Drug: choline magnesium trisalicylateCholine Magnesium Trisalicylate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| choline magnesium trisalicylate1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48. | Drug | Choline Magnesium Trisalicylate, Dexamethasone plus Choline Magnesium Trisalicylate |
| Dexamethasone10mg orally every 6 hours beginning at hour 0 and continuing until hour 48. | Drug | Dexamethasone plus Choline Magnesium Trisalicylate |
Primary outcome
Temporal changes in leukemic cell NF-kB activity
Time frame: 5 years
2 secondary outcomes
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Time frame: 5 years
Apoptosis related to NF-kB modulation
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Replaced by another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Results publication: PubMed 19010875Strair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8. doi: 10.1158/1078-0432.CCR-08-1390.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Roger Strair, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing choline magnesium trisalicylate and Dexamethasone in people with Leukemia, run by Rutgers, The State University of New Jersey 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?
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 19 Nov 2013. 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 was stopped early (reason given: Replaced by another study). 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?
Temporal changes in leukemic cell NF-kB activity (time frame: 5 years). 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 NCT00156299, which also lists 1 linked publication.
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 19 Nov 2013.