Acute Lymphoblastic LeukemiaPhase 1/2NCT00144963

Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

A Phase 1/2 study testing Vincristine Sulfate Liposomes Injection and Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Acrotech Biopharma Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Read more about this study

Who is it for?: Any age
Conditions the study is for: Acute Lymphoblastic Leukemia
What is being tested?: Vincristine Sulfate Liposomes Injection and Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesUnited States
Study dates: Jul 2002to Aug 2006
Phase: Phase 1/2
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

Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease.
Performance status ≤3 (ECOG).
All ages are eligible. Those aged 12 years or older may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
Adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
Negative pregnancy test in females of childbearing potential.
Patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.

Who cannot join

Active serious infection not controlled by oral or intravenous antibiotics.
Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
Concurrent treatment with other anti-cancer agents other than dexamethasone.
Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.
History of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
Prior history of hypersensitivity reactions to vincristine or any of the other components of VSLI.
Pregnant and/or lactating women; or fertile men or women not willing to use contraception.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Emory University
Atlanta, Georgia, 30322
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia

Read the detailed description

OBJECTIVES:

Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Conditions: Acute Lymphoblastic Leukemia
Being tested: Vincristine Sulfate Liposomes Injection, Dexamethasone
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vincristine Sulfate Liposomes InjectionDrug
Also called Marqibo
Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
DexamethasoneDrug
Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

Study groups in NCT00144963
Study group	Role	What they receive
VSLI	Experimental	Vincristine Sulfate Liposomes Injection (VSLI) Receives: Drug: Vincristine Sulfate Liposomes Injection; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

MTD of VSLI
Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2002Aug 2006

First posted5 Sep 2005 (estimated)
Study startJul 2002
Primary completionAug 2006
Study completionAug 2006

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.
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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00144963
Sponsor's protocol ID: VSLI-06-ALL
Status last verified: Dec 2019
First submitted: 1 Sep 2005
Last updated: 12 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Lymphoblastic Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT00144963
Acronym / sponsor ID: VSLI-06-ALL
Conditions: Acute Lymphoblastic Leukemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
Study start: Jul 2002
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 5 Sep 2005 (estimated)
Results: Posted 18 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VSLI	Experimental	Drug: Vincristine Sulfate Liposomes Injection, Drug: DexamethasoneVincristine Sulfate Liposomes Injection (VSLI)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease.
Performance status ≤3 (ECOG).
All ages are eligible. Those aged 12 years or older may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
Adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
Negative pregnancy test in females of childbearing potential.

Key exclusion criteria (8 listed)

Active serious infection not controlled by oral or intravenous antibiotics.
Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
Concurrent treatment with other anti-cancer agents other than dexamethasone.
Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.

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
Vincristine Sulfate Liposomes InjectionAlso: MarqiboStudy treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).	Drug	VSLI
DexamethasoneStudy treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).	Drug	VSLI

Primary outcome

MTD of VSLI
Time frame: 6 weeks
Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.

Results and safety

Results posted to the registry on 18 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VSLI	36	36

Primary outcome: MTD of VSLI

Time frame: 6 weeks. Number. Unit: mg/m2

Measure	VSLI n = 26
Value	2.25

Population analysed: This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.

Adverse events

Time frame: start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VSLI	33 of 36 (91.7%)	36 of 36 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical trial information from M.D. Anderson Cancer Center's websiteLink provided by the sponsor.

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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.

Deborah Thomas, MD principal investigator

MD Anderson Cancer Center, Department of Hematology/Oncology

Wendy Stock, MD principal investigator

University of Chicago

Leonard Heffner, MD principal investigator

Emory University

3 sites 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 Vincristine Sulfate Liposomes Injection and Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Acrotech Biopharma Inc. at 3 sites 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 6 inclusion and 8 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 18 Jan 2012). 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?

MTD of VSLI (time frame: 6 weeks). 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 NCT00144963.

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 12 Dec 2019.