T-Cell Large Granular Lymphocytic LeukemiaPhase 2NCT00278265
Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia
A Phase 2 study testing MTX followed by fludarabine in people with T-Cell Large Granular Lymphocytic Leukemia, run by German CLL Study Group at 7 sites in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, 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
- Conditions the study is for
- T-Cell Large Granular Lymphocytic Leukemia
- What is being tested?
- MTX followed by fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesGermany
- Study dates
- Jun 2005to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia
- Must have concurrent anemia or neutropenia
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 2 years
- Not pregnant
- Fertile patients must use effective contraception
- No other malignancy
- No active infection
PRIOR CONCURRENT THERAPY:
- No prior immunosuppressive treatment
- No previous treatment with methotrexate or fludarabine
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, D-13125
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24105
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, D-80337
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, D-73557
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, 22844
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081
About this study
Official title: First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)
RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, 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 II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic (T-LGL) leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate (MTX) as first-line therapy
- Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy.
Secondary
- Determine the side effects of these drugs in these patients.
- Determine the rate of molecular remissions in patients treated with these drugs.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity. Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3. Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Being tested
- MTX followed by fludarabine
- Keywords
- T-cell large granular lymphocyte leukemia, anemia, neutropenia
- Medical subject headings
- Leukemia, Large Granular Lymphocytic, Anemia, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX followed by fludarabineDrug
Also called methotrexate, fludarabine phosphate
MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| MTX followed by fludarabine | Experimental | MTX is given with a dose of 10-20mg weekly Fludarabine is dosed with 25mg/m2 day 1-3 of 28 days, up to 4 cycles Receives: Drug: MTX followed by fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) [20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
Measured: 12 months after inclusion in the study
Secondary outcomes (3)
Duration of remission
he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) [20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
Measured: up to 24 months after inclusion in the study
Molecular remission rate
Measured: 2 months after the last dose of study medication
Adverse events rate and severity
Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)
Measured: up to 28 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Large Granular Lymphocytic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- German CLL Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kneba, Study chair, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278265
- Sponsor's protocol ID
- LGL1
- Other IDs
- GCLLSG-LGL1, EU-20564, CDR0000454596
- Status last verified
- Sep 2016
- First submitted
- 16 Jan 2006
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)
- ClinicalTrials.gov ID
- NCT00278265
- Acronym / sponsor ID
- LGL1
- Keywords
- T-cell large granular lymphocyte leukemia, anemia, neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- German CLL Study GroupUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jan 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 methotrexate and fludarabine, 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 II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia.
Detailed description
OBJECTIVES:
Primary
- Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic (T-LGL) leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate (MTX) as first-line therapy
- Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy.
Secondary
- Determine the side effects of these drugs in these patients.
- Determine the rate of molecular remissions in patients treated with these drugs.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity. Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3. Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTX followed by fludarabine | Experimental | Drug: MTX followed by fludarabineMTX is given with a dose of 10-20mg weekly Fludarabine is dosed with 25mg/m2 day 1-3 of 28 days, up to 4 cycles |
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 |
|---|---|---|
| MTX followed by fludarabineAlso: methotrexate, fludarabine phosphateMTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles | Drug | MTX followed by fludarabine |
Primary outcome
Response rate
Time frame: 12 months after inclusion in the study
he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) [20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
3 secondary outcomes
Duration of remission
Time frame: up to 24 months after inclusion in the study
Molecular remission rate
Time frame: 2 months after the last dose of study medication
Adverse events rate and severity
Time frame: up to 28 days after the last dose of study medication
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Michael Kneba study chair
University Hospital Schleswig-Holstein
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTX followed by fludarabine in people with T-Cell Large Granular Lymphocytic Leukemia, run by German CLL Study Group at 7 sites in Germany.
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: stopped early, as of the sponsor's last update on 3 Oct 2016. 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 Germany. 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
Response rate (time frame: 12 months after inclusion in the study). 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 3 Oct 2016.