LeukemiaPhase 1/2NCT00304005
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
A Phase 1/2 study testing laromustine in people with Leukemia and Lymphoma, run by Vion Pharmaceuticals at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- laromustine
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2008
- Phase
- Phase 1/2
- 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:
- Diagnosis of 1 of the following hematologic malignancies:
- Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
- CLL in transformation allowed
- Richter syndrome
- Other refractory lymphoproliferative diseases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Renal dysfunction due to organ infiltration by disease allowed
- AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
- Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No symptomatic coronary artery disease
- No arrhythmia not controlled by medication
- No uncontrolled, symptomatic congestive heart failure
- No myocardial infarction within the past 3 months
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
- No other concurrent standard or investigational treatment for this cancer
- No other concurrent cytotoxic investigational drugs
- No concurrent disulfiram
Trial locations and contacts
1 site in 1 country.
United States1 site
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
About this study
Official title: A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
- Phase II: Patients receive VNP40101M at the MTD determined in phase I.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Being tested
- laromustine
- Keywords
- refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laromustineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Toxicity
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bonny L. Johnson, RN, MSN, Study chair, Vion Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304005
- Sponsor's protocol ID
- VION-CLI-041
- Other IDs
- CDR0000465217, MDA-2005-0249
- Status last verified
- Aug 2008
- First submitted
- 15 Mar 2006
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
- ClinicalTrials.gov ID
- NCT00304005
- Acronym / sponsor ID
- VION-CLI-041
- Keywords
- refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Vion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Mar 2006 (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: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
- Phase II: Patients receive VNP40101M at the MTD determined in phase I.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| laromustine | Drug | – |
Primary outcome
Maximum tolerated dose
Toxicity
Efficacy
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 18 Jul 2013.
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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.
Bonny L. Johnson, RN, MSN study chair
Vion Pharmaceuticals
1 site 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 laromustine in people with Leukemia and Lymphoma, run by Vion Pharmaceuticals 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: finished, as of the sponsor's last update on 18 Jul 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 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?
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?
Maximum tolerated dose. The study lists 3 primary outcomes in all. 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 18 Jul 2013.