Hematologic MalignanciesPhase 1UPCC 04701NCT00780052
Infusional C-myb ASODN in Advanced Hematologic Malignancies
A Phase 1 study testing c-myb AS ODN in people with Hematologic Malignancies, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- c-myb AS ODN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2011
- 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
Who may be able to join
- Patients must have one of the following: acute myeloid or lymphoid leukemia; or Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or Multiple Myeloma
- Patients with acute leukemia must meet one of the following conditions:
- have disease which is refractory to a course of standard induction chemotherapy have relapsed diseased after documentation of previous clinical remission or have untreated disease and not be a candidate for conventional first line treatment
- Patients with CML or other MPD must have evidence of accelerated phase or blast crisis
- Patients having clinical features of CML in transformation but who are negative for Philadelphia chromosome may be entered provided there is a prior definable chronic phase
- Patients with Philadelphia chromosome positive CML must have failed treated with Gleevec (Imatinib) in order to be eligible for study
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- Patients with myelodysplastic syndrome (MDS) must have > 5% blasts in the peripheral blood or bone marrow and have at diagnosis as IPSS score of >= 1
- Patients with CLL must have relapsed or refractory disease after at least three courses of conventional therapy and have been determined to no longer be a candidate for conventional therapy
- Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or refractory disease after at least two courses of chemotherapy and have been determined not to be a candidate for further conventional therapies
- Patients with multiple myeloma must have failed at least 3 prior therapies
- Performance Status 0, 1 or 2
- Serum creatinine < 2.0 mg/dl; serum bilirubin < 2 mg/dl and AST/ALT < 3.0 x upper limit of normal
- PTT within normal range
- Age > 18
- Patients must have an indwelling central venous catheter
Who cannot join
- Significant cardiac disease which requires active therapy
- Intercurrent organ damage or medical problems that will jeopardize outcome of therapy
- Pregnant or lactating females
- Received prior c-myb AS ODN therapy
- Patients with suitable HLA identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation
- Patients requiring anticoagulation with unfractionated heparin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.
- Conditions
- Hematologic Malignancies
- Being tested
- c-myb AS ODN
- Keywords
- Hematologic Malignancies, c-myb, c-myb AS ODN
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-myb AS ODNDrug
Subjects will be admitted to the hospital to receive c-myb AS ODN as a 24-hour continuous intravenous infusion over 7 days. Dose level is increased with each new subject to determine if there is a MTD.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | c-myb AS ODN as a 24-hour continuous infusion over 7 days Receives: Drug: c-myb AS ODN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
Measured: At study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startSep 2002
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selina Luger, MD, Principal investigator, University of Pennsylvania Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780052
- Sponsor's protocol ID
- UPCC 04701
- Acronym
- UPCC 04701
- Status last verified
- Dec 2011
- First submitted
- 24 Oct 2008
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00780052
- Acronym / sponsor ID
- UPCC 04701 / UPCC 04701
- Conditions
- Hematologic Malignancies
- Keywords
- Hematologic Malignancies, c-myb, c-myb AS ODN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Oct 2008 (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.
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: c-myb AS ODNc-myb AS ODN as a 24-hour continuous infusion over 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have one of the following: acute myeloid or lymphoid leukemia; or Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or Multiple Myeloma
- Patients with acute leukemia must meet one of the following conditions:
- have disease which is refractory to a course of standard induction chemotherapy have relapsed diseased after documentation of previous clinical remission or have untreated disease and not be a candidate for conventional first line treatment
- Patients with CML or other MPD must have evidence of accelerated phase or blast crisis
- Patients having clinical features of CML in transformation but who are negative for Philadelphia chromosome may be entered provided there is a prior definable chronic phase
Key exclusion criteria (6 listed)
- Significant cardiac disease which requires active therapy
- Intercurrent organ damage or medical problems that will jeopardize outcome of therapy
- Pregnant or lactating females
- Received prior c-myb AS ODN therapy
- Patients with suitable HLA identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation
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 |
|---|---|---|
| c-myb AS ODNSubjects will be admitted to the hospital to receive c-myb AS ODN as a 24-hour continuous intravenous infusion over 7 days. Dose level is increased with each new subject to determine if there is a MTD. | Drug | 1 |
Primary outcome
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
Time frame: At study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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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.
Selina Luger, MD principal investigator
University of Pennsylvania Abramson Cancer Center
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 c-myb AS ODN in people with Hematologic Malignancies, run by Abramson Cancer Center at Penn Medicine 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 15 inclusion and 6 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 26 Sep 2016. 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?
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN (time frame: At study completion). 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 26 Sep 2016.