LeukemiaNCT00003837
506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
A study testing nelarabine in people with Leukemia and Lymphoma, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- nelarabine
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 1999to Nov 2007
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
- Tumor cells should exhibit phenotypic characteristics of these diseases
- No CNS involvement requiring intrathecal or craniospinal radiotherapy
- Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-3 OR
- Karnofsky 40-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
Other:
- No neuropathy grade 2 or higher
- No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
- No active seizure disorder
- No active infection
- No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior bone marrow transplantation allowed
- No concurrent allogeneic bone marrow transplantation
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
- No prior 506U78
Endocrine therapy:
- No concurrent systemic steroid therapy
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy allowed
Surgery:
- Not specified
Other:
- No other concurrent investigational therapy
- No concurrent treatment for seizures
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
NCI - Pharmaceutical Management Branch
Bethesda, Maryland, 20892
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5047
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612
About this study
Official title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Read the detailed description
OBJECTIVES:
- Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
- Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
- Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
- Being tested
- nelarabine
- Keywords
- recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelarabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Secondary outcomes (2)
Toxicity
Antitumor efficacy as defined by the rate of complete hematologic responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1999
- Study completionNov 2007
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.
- More trials run by National Cancer Institute (NCI)The 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Anthony J. Murgo, MD, Study chair, NCI - Investigational Drug Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003837
- Sponsor's protocol ID
- CDR0000066994
- Other IDs
- CTEP-TRC-9701, CWRU-TRC-1499
- Status last verified
- Dec 2005
- First submitted
- 1 Nov 1999
- Last updated
- 20 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT00003837
- Acronym / sponsor ID
- CDR0000066994
- Keywords
- recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, recurrent adult lymphoblastic lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Detailed description
OBJECTIVES:
- Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
- Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
- Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| nelarabine | Drug | – |
Primary outcome
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
2 secondary outcomes
Toxicity
Antitumor efficacy as defined by the rate of complete hematologic responses
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 20 Jun 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.
Anthony J. Murgo, MD study chair
NCI - Investigational Drug Branch
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nelarabine in people with Leukemia and Lymphoma, run by National Cancer Institute (NCI) at 7 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?
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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority. 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 20 Jun 2013.