LymphomaPhase 2NCT00080535
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Cutaneous T-Cell Lymphomas
A Phase 2 study testing LMB-2 in people with Lymphoma and T-Cell, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LMB-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2004to 31 Dec 2011
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histopathological evidence of cluster of differentiation 25 (CD25) + cutaneous T-cell lymphoma (CTCL) confirmed by the National Institutes of Health (NIH) pathology department.
- One of the following must be present:
- Greater than or equal to 20 percent expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor.
- Greater than or equal to 20 percent of the peripheral blood Sezary cells must be CD25+.
- Measurable stage Ib-IV disease that has progressed after at least 2 prior systemic or topical therapies.
- Patients must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and be at least 18 years old.
Show all 19Show fewer
- Patients must be able to understand and give informed consent.
- Patients must be 4 weeks from any monoclonal antibodies.
- Patients must be greater than or equal to 3 weeks from any CTCL-specific therapy and have evidence of progressive disease.
- Patients who are on chronic steroids must be on a stable dose of Prednisone less than or equal to 20 mg/day (or equivalent dose of another steroid) for at least 3 weeks and have evidence of progressive disease.
- Female patients of childbearing potential must have a negative pregnancy test and must use effective contraception (a barrier form of contraception).
- The transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must each be less than or equal to 2.5-times the upper limits of normal.
- Albumin must be greater than or equal to 3.0 gm/dL.
- Total bilirubin must be less than or equal to 2.2 mg/dL.
- The creatinine must be less than or equal to 2.0 mg/dL or the creatinine clearance must be greater than or equal to 50 ml/min.
- The absolute neutrophil count (ANC) must be greater than or equal to 1000/mm^3 and the unsupported platelet count must be greater than or equal to 50,000/mm^3 in patients without blood or bone marrow involvement.
- If there is blood or bone marrow involvement, the ANC must be greater than or equal to 500 mm^3 and the platelets must be greater than or equal to 10,000/mm^3.
- The cardiac ejection fraction as assessed by echocardiogram or nuclear medicine study must not be less than the institutional limit of normal.
- Pulmonary function studies must demonstrate a carbon monoxide diffusing capacity (DLCO) greater than or equal to 55 percent and a forced expiratory volume 1 (FEV1) greater than or equal to 60 percent of normal for inclusion.
Who cannot join
- Patients whose serum neutralizes LMB-2 in tissue culture, due either to anti-toxin or anti-mouse-IgG antibodies.
- No patient whose serum neutralizes greater than 75 percent of the activity of 1 microg/mL of LMB-2 will be treated.
- Patients who are pregnant or breast-feeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
- symptomatic congestive heart failure,
- unstable angina pectoris,
Show all 16Show fewer
- cardiac arrhythmia,
- or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are human immunodeficiency virus (HIV) positive,
- hepatitis B antigen positive,
- hepatitis C polymerase chain reaction (PCR) positive,
- or who have other chronic liver disease.
- Patients with symptomatic cardiac or pulmonary disease.
- Patients on warfarin therapy.
- Such patients may be eligible if they can be switched to heparin or low-molecular weight heparin therapy and are off warfarin at least 4 days prior to study enrollment.
- Active cancer requiring treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Cutaneous T-Cell Lymphomas
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts: a genetically engineered monoclonal antibody that binds to CD25, and a toxin produced by bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD25-containing cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness in shrinking tumors in patients with various types of lymph and blood cancers.
Patients 18 years of age and older with stage 1b to IV cutaneous T-cell lymphoma that has progressed within 2 years of systemic or topical therapy and who have CD25 receptor proteins on their cancer cells may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis, skin punch biopsy to evaluate tumor infiltration in the skin, and a bone marrow biopsy on patients with stage IIa disease and higher. In addition, the patient's blood, bone marrow, tumor, or other tissue is tested to determine the presence of CD25 on cancer cells.
Read more
Participants receive up to nine cycles of LMB-2 therapy as long as their cancer does not worsen and they do not develop serious side effects. Each 28-day cycle consists of 30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line - an IV tube placed in a large vein in the neck or chest that leads to the heart. In addition to drug therapy, patients undergo the following procedures:
Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood tests are also done before and during each cycle to determine how the immune system is interacting with the drug.
Disease evaluations: Patients undergo a careful skin examination, blood tests, chest x-ray, and EKG before each treatment cycle and at follow-up visits. A CT scan and echocardiogram (heart ultrasound) are done before the first cycle. Before the first and second cycles, patients have a biopsy of the lymphoma on the skin. If the biopsy is helpful in evaluating the disease response to LMB-2, additional biopsies may be requested prior to other cycles as well. A nuclear medicine scan may be done, and a bone marrow biopsy may be done in patients with stage II to IV disease. If these tests are helpful in understanding the response of the lymphoma to treatment, they may also be repeated prior to other cycles, with the patient's permission.
Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. Subsequent cycles are given as outpatients. If the infusions are well tolerated, patients may return home after about one week (or possibly longer if complications occur). After returning home, patients have blood tests done weekly by their local physicians.
Read the detailed description
Background:
It is estimated that 40-50% of patients with cutaneous T-cell lymphoma (CTCL) have tumors that express cluster of differentiation 25 (CD25) (Tac or IL2Ra). Normal resting T-cells do not express CD25. LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of MAb anti-Tac and truncated Pseudomonas exotoxin. A phase I trial at National Cancer Institute (NCI) found that the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (QOD times 3) with prophylactic IV fluid. The most common adverse events were transient fever, hypoalbuminemia and transaminase elevations. In that trial, two of two patients with cutaneous T-cell lymphoma had clinical benefit (1 partial response (PR), 1 stable disease (SD)). In 1999 another recombinant fusion protein, denileukin diftitox, was approved by the Food and Drug Administration (FDA) for treatment of patients with advanced or recurrent CTCL expressing the high affinity interleukin-2 (IL-2) receptor. This receptor is composed of three subunits: CD25, CD122 and CD132. Because LMB-2 is cytotoxic to cells expressing CD25 without the other IL-2 receptor subunits needed to form the high affinity receptor, CD25+ CTCL patients are good candidates for further testing with LMB-2.
Objectives:
The purpose of this study is to determine the activity of anti-Tac(Fv)-PE38 (LMB-2) in patients with Tac-expressing Cutaneous T-cell Lymphoma (CTCL). The primary endpoints of this trial are the response rate and response duration. We will also evaluate LMB-2 immunogenicity, pharmacokinetics, and toxicity, and monitor soluble Tac levels in the serum. These will be evaluated using routine hematologic and clinical evaluation, and when appropriate, by monitoring the phenotype of circulating T-cells or of biopsied tissues using antibodies to CD25.
Eligibility:
CD25+ CTCL based on immunohistochemistry or flow cytometry of blood. Patients must have measurable stage 1b-IV disease which progressed after greater than or equal 2 prior systemic or topical therapies. Labs required: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5-time upper limit, albumin greater than or equal 3, bilirubin less than or equal to 2.2, creatinine less than or equal to 2.0 (unless creatinine clearance greater than or equal to 50 ml/min), absolute neutrophil count (ANC) greater than or equal to 1000/ul, and platelets greater than or equal to 50,000/ul (ANC and platelets greater than or equal 500 and 10,000 if blood/marrow involvement).
Design:
Patients receive LMB-2 30 ug/Kg QOD time 3 every 4 weeks in absence of neutralizing antibodies or progressive disease. Dose escalation to 40 ug/Kg QOD times 3 if less than 2/6 dose limiting toxicity (DLT) at 30 ug/Kg times 3. 1st stage is 16 patients, to expand to 25 if greater than 1 of 16 patients respond.
- Being tested
- LMB-2
- Keywords
- LMB-2, Cutaneous T Cell Lymphoma, CTCL, Immunotoxin, Oncology
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Cutaneous, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMB-2Biological
30 micrograms/kg every other day (QOD) x 3 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| LMB-2 for cutaneous Tcell lymphoma | Experimental | 30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation. Receives: Biological: LMB-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.
Measured: Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.
Secondary outcomes (1)
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2004 (estimated)
- Study start30 Apr 2004
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Robert Kreitman, M.D., National Cancer Institute (NCI)
- Investigators
- Robert J Kreitman, M.D., Principal investigator, National Cancer Institute, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080535
- Sponsor's protocol ID
- 040142
- Other IDs
- 04-C-0142
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2004
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RS, Pandolfino T, Guitart J, Rosen S, Kuzel TM. Primary cutaneous T-cell lymphoma: review and current concepts. J Clin Oncol. 2000 Aug;18(15):2908-25. doi: 10.1200/JCO.2000.18.15.2908.
PubMed 10920140Diamandidou E, Cohen PR, Kurzrock R. Mycosis fungoides and Sezary syndrome. Blood. 1996 Oct 1;88(7):2385-409. No abstract available.
PubMed 8839829Weinstock MA, Horm JW. Mycosis fungoides in the United States. Increasing incidence and descriptive epidemiology. JAMA. 1988 Jul 1;260(1):42-6.
PubMed 3379722Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.
PubMed 18596230
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Cutaneous T-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00080535
- Acronym / sponsor ID
- 040142
- Keywords
- LMB-2, Cutaneous T Cell Lymphoma, CTCL, Immunotoxin, Oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Apr 2004 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 7 Apr 2004 (estimated)
- Results
- Posted 24 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts: a genetically engineered monoclonal antibody that binds to CD25, and a toxin produced by bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD25-containing cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness in shrinking tumors in patients with various types of lymph and blood cancers.
Patients 18 years of age and older with stage 1b to IV cutaneous T-cell lymphoma that has progressed within 2 years of systemic or topical therapy and who have CD25 receptor proteins on their cancer cells may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis, skin punch biopsy to evaluate tumor infiltration in the skin, and a bone marrow biopsy on patients with stage IIa disease and higher. In addition, the patient's blood, bone marrow, tumor, or other tissue is tested to determine the presence of CD25 on cancer cells.
Participants receive up to nine cycles of LMB-2 therapy as long as their cancer does not worsen and they do not develop serious side effects. Each 28-day cycle consists of 30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line - an IV tube placed in a large vein in the neck or chest that leads to the heart. In addition to drug therapy, patients undergo the following procedures:
Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood tests are also done before and during each cycle to determine how the immune system is interacting with the drug.
Disease evaluations: Patients undergo a careful skin examination, blood tests, chest x-ray, and EKG before each treatment cycle and at follow-up visits. A CT scan and echocardiogram (heart ultrasound) are done before the first cycle. Before the first and second cycles, patients have a biopsy of the lymphoma on the skin. If the biopsy is helpful in evaluating the disease response to LMB-2, additional biopsies may be requested prior to other cycles as well. A nuclear medicine scan may be done, and a bone marrow biopsy may be done in patients with stage II to IV disease. If these tests are helpful in understanding the response of the lymphoma to treatment, they may also be repeated prior to other cycles, with the patient's permission.
Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. Subsequent cycles are given as outpatients. If the infusions are well tolerated, patients may return home after about one week (or possibly longer if complications occur). After returning home, patients have blood tests done weekly by their local physicians.
Detailed description
Background:
It is estimated that 40-50% of patients with cutaneous T-cell lymphoma (CTCL) have tumors that express cluster of differentiation 25 (CD25) (Tac or IL2Ra). Normal resting T-cells do not express CD25. LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of MAb anti-Tac and truncated Pseudomonas exotoxin. A phase I trial at National Cancer Institute (NCI) found that the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (QOD times 3) with prophylactic IV fluid. The most common adverse events were transient fever, hypoalbuminemia and transaminase elevations. In that trial, two of two patients with cutaneous T-cell lymphoma had clinical benefit (1 partial response (PR), 1 stable disease (SD)). In 1999 another recombinant fusion protein, denileukin diftitox, was approved by the Food and Drug Administration (FDA) for treatment of patients with advanced or recurrent CTCL expressing the high affinity interleukin-2 (IL-2) receptor. This receptor is composed of three subunits: CD25, CD122 and CD132. Because LMB-2 is cytotoxic to cells expressing CD25 without the other IL-2 receptor subunits needed to form the high affinity receptor, CD25+ CTCL patients are good candidates for further testing with LMB-2.
Objectives:
The purpose of this study is to determine the activity of anti-Tac(Fv)-PE38 (LMB-2) in patients with Tac-expressing Cutaneous T-cell Lymphoma (CTCL). The primary endpoints of this trial are the response rate and response duration. We will also evaluate LMB-2 immunogenicity, pharmacokinetics, and toxicity, and monitor soluble Tac levels in the serum. These will be evaluated using routine hematologic and clinical evaluation, and when appropriate, by monitoring the phenotype of circulating T-cells or of biopsied tissues using antibodies to CD25.
Eligibility:
CD25+ CTCL based on immunohistochemistry or flow cytometry of blood. Patients must have measurable stage 1b-IV disease which progressed after greater than or equal 2 prior systemic or topical therapies. Labs required: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5-time upper limit, albumin greater than or equal 3, bilirubin less than or equal to 2.2, creatinine less than or equal to 2.0 (unless creatinine clearance greater than or equal to 50 ml/min), absolute neutrophil count (ANC) greater than or equal to 1000/ul, and platelets greater than or equal to 50,000/ul (ANC and platelets greater than or equal 500 and 10,000 if blood/marrow involvement).
Design:
Patients receive LMB-2 30 ug/Kg QOD time 3 every 4 weeks in absence of neutralizing antibodies or progressive disease. Dose escalation to 40 ug/Kg QOD times 3 if less than 2/6 dose limiting toxicity (DLT) at 30 ug/Kg times 3. 1st stage is 16 patients, to expand to 25 if greater than 1 of 16 patients respond.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LMB-2 for cutaneous Tcell lymphoma | Experimental | Biological: LMB-230 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histopathological evidence of cluster of differentiation 25 (CD25) + cutaneous T-cell lymphoma (CTCL) confirmed by the National Institutes of Health (NIH) pathology department.
- Greater than or equal to 20 percent expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor.
- Greater than or equal to 20 percent of the peripheral blood Sezary cells must be CD25+.
- Measurable stage Ib-IV disease that has progressed after at least 2 prior systemic or topical therapies.
- Patients must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and be at least 18 years old.
Key exclusion criteria (16 listed)
- Patients whose serum neutralizes LMB-2 in tissue culture, due either to anti-toxin or anti-mouse-IgG antibodies.
- No patient whose serum neutralizes greater than 75 percent of the activity of 1 microg/mL of LMB-2 will be treated.
- Patients who are pregnant or breast-feeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
- symptomatic congestive heart failure,
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 |
|---|---|---|
| LMB-230 micrograms/kg every other day (QOD) x 3 every 4 weeks | Biological | LMB-2 for cutaneous Tcell lymphoma |
Primary outcome
Response Rate
Time frame: Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.
Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10920140Siegel RS, Pandolfino T, Guitart J, Rosen S, Kuzel TM. Primary cutaneous T-cell lymphoma: review and current concepts. J Clin Oncol. 2000 Aug;18(15):2908-25. doi: 10.1200/JCO.2000.18.15.2908.
- Background: PubMed 8839829Diamandidou E, Cohen PR, Kurzrock R. Mycosis fungoides and Sezary syndrome. Blood. 1996 Oct 1;88(7):2385-409. No abstract available.
- Background: PubMed 3379722Weinstock MA, Horm JW. Mycosis fungoides in the United States. Increasing incidence and descriptive epidemiology. JAMA. 1988 Jul 1;260(1):42-6.
- Derived from this study: PubMed 18596230Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.
- International Workshop to Standardize Response Criteria for Non-Hodgkin's LymphomasLink provided by the sponsor.
- 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.
Robert J Kreitman, M.D. principal investigator
National Cancer Institute, National Institutes of Health
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 LMB-2 in people with Lymphoma and T-Cell, 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 19 inclusion and 16 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 29 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 24 Oct 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?
Response Rate (time frame: Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.). 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 NCT00080535, which also lists 4 linked publications.
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 29 Jan 2018.