Anaplastic Large Cell LymphomaPhase 2NCT00005080
506U78 in Treating Patients With Lymphoma
A Phase 2 study testing nelarabine in people with Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma
- What is being tested?
- nelarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Jan 2006
- Phase
- Phase 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including:
- Mycosis fungoides/Sezary syndrome
- Peripheral T-Cell lymphomas (medium, mixed medium-large, large cell)
- Variants of peripheral T-Cell lymphoma
- Angioimmunoblastic T-Cell lymphoma (AILD); angiocentric lymphoma; intestinal T-Cell Lymphoma; adult T-Cell lymphoma/leukemia (ATLL); anaplastic Large Cell (CD30+) lymphoma, T-cell type Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible; Note: patients diagnosed more than one year prior to entry on this protocol must have a repeat lymph node biopsy. In the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required
- Biopsy and immunophenotyping should be performed to document relapse after prior treatment
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- CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, and fusion toxins
- PTCL patients may have failed only one or two prior treatment regimens (one of which may include peripheral stem cell transplantation)
- Patients must have measurable disease; patients with CTCL must have skin lesions which are measurable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure
- The following lesions are not considered measurable:
- Barium studies
- Ascites or pleural effusion
- Bony disease (lesions if present should be noted)
- Bone marrow
- No CNS lymphoma requiring intrathecal or craniospinal radiation therapy
- No history of a seizure disorder or grade 3 neurologic toxicity during prior treatment of lymphoma. Baseline neurologic status of all eligible patients is to be carefully recorded (particularly in elderly patients and those with conditions potentially predisposed to neurotoxicity, such as diabetes mellitus and prior exposure to neurotoxic agents); patients with prior neurologic dysfunction or toxicity from any cause must have recovered to grade 1 neurologic toxicity/dysfunction
- Performance status 0-2
- No known HIV disease; patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; patients who test positive or who are known to be infected are not eligible; an HIV test is not required for entry on protocol, but is required if the patient is perceived to be at risk
- Calculated Creatinine Clearance >= 50 ml/min
- Unless attributable to lymphoma
- To be calculated by method of Cockcroft-Gault
- Bilirubin >= 1.5 x upper limit of normal
- Patients with hepatic dysfunction should enroll on CALGB 69803
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)
Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78.
II. Determine the safety and toxicity of this treatment regimen in this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse.
PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
- Conditions
- Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Small Intestine Lymphoma
- Being tested
- nelarabine
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelarabineDrug
Also called 506U78, Arranon, GW506U78
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Nelarabine | Experimental | Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy. Receives: Drug: nelarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate (complete and partial remission)
Measured: Up to 2 years
Remission duration
Remission duration will be estimated using the method of Kaplan Meier.
Measured: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years
Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startMay 2000
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Large Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Myron Czuczman, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005080
- Sponsor's protocol ID
- NCI-2012-02324
- Other IDs
- CALGB-59901, U10CA031946, CDR0000067687
- Status last verified
- Jan 2013
- First submitted
- 6 Apr 2000
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT00005080
- Acronym / sponsor ID
- NCI-2012-02324
- Conditions
- Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Small Intestine Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2000
- Primary completion
- Jan 2006 (actual)
- First posted
- 19 Apr 2004 (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.
Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed description
PRIMARY OBJECTIVES:
- Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78.
II. Determine the safety and toxicity of this treatment regimen in this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse.
PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelarabine | Experimental | Drug: nelarabinePatients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy. |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including:
- Biopsy and immunophenotyping should be performed to document relapse after prior treatment
- CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, and fusion toxins
- PTCL patients may have failed only one or two prior treatment regimens (one of which may include peripheral stem cell transplantation)
- Patients must have measurable disease; patients with CTCL must have skin lesions which are measurable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nelarabineAlso: 506U78, Arranon, GW506U78Given IV | Drug | Nelarabine |
Primary outcome
Remission rate (complete and partial remission)
Time frame: Up to 2 years
Remission duration
Time frame: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years
Remission duration will be estimated using the method of Kaplan Meier.
Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 2 years
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 16 Jan 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.
Myron Czuczman principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nelarabine in people with Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by National Cancer Institute (NCI) 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 23 inclusion and 0 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 16 Jan 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 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?
Remission rate (complete and partial remission) (time frame: Up to 2 years). 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 16 Jan 2013.