LymphomaPhase 2NCT00070291
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
A Phase 2 study testing cyclosporine in people with Lymphoma, run by Eastern Cooperative Oncology Group at 23 sites in United States.
Trial summary
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma. PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 23 sitesUnited States
- Study dates
- 24 Jan 2006to May 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
- Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
- At least one objective measurable or evaluable disease parameter.
- Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
- Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
- Total bilirubin <= 2x the upper limit of normal.
- Age 18 or older.
Who cannot join
- Prior cyclosporine or Tacrolimus (FK506).
- Prior allogeneic transplant.
- Evidence of active infection.
- Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
- Evidence of active neurological impairment.
- Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
Show all 9Show fewer
- History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
- pregnant or breastfeeding women.
- Human immunodeficiency virus (HIV) positive.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, 60402
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, 60611
Saint Joseph Hospital
Chicago, Illinois, 60657
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048
St. Rita's Medical Center
Lima, Ohio, 45801
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360
La Grange Oncology Associates - Geneva
Naperville, Illinois, 60563
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076
Stanford Cancer Center
Stanford, California, 94305-5824
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
- Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
- Conditions
- Lymphoma
- Being tested
- cyclosporine
- Keywords
- angioimmunoblastic T-cell lymphoma
- Medical subject headings
- Lymphoma, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
Also called CSA,, Neoral,, Gengraf
Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Experimental | High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment. Receives: Drug: cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Complete and Partial Response)
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
Measured: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.
Secondary outcomes (1)
Overall Survival
Overall survival was defined as time from randomization to death from any cause.
Measured: Assessed every 3 months for 2 years, then every 6 months for 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study start24 Jan 2006
- Primary completionMar 2009
- Study completionMay 2011
Why it stopped: Slow accrual.
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 LymphomaStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ranjana Advani, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070291
- Sponsor's protocol ID
- CDR0000331864
- Other IDs
- U10CA021115, E2402
- Status last verified
- Jun 2023
- First submitted
- 3 Oct 2003
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00070291
- Acronym / sponsor ID
- CDR0000331864
- Conditions
- Lymphoma
- Keywords
- angioimmunoblastic T-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jan 2006 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Posted 8 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
- Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Experimental | Drug: cyclosporineHigh dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
- At least one objective measurable or evaluable disease parameter.
- Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
Key exclusion criteria (9 listed)
- Prior cyclosporine or Tacrolimus (FK506).
- Prior allogeneic transplant.
- Evidence of active infection.
- Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
- Evidence of active neurological impairment.
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 |
|---|---|---|
| cyclosporineAlso: CSA,, Neoral,, GengrafCyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity | Drug | Cyclosporine |
Primary outcome
Response Rate (Complete and Partial Response)
Time frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
1 secondary outcome
Overall Survival
Time frame: Assessed every 3 months for 2 years, then every 6 months for 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ranjana Advani, MD study chair
Stanford University
23 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 cyclosporine in people with Lymphoma, run by Eastern Cooperative Oncology Group at 23 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 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 8 Feb 2013). 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 (Complete and Partial Response) (time frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.). 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 29 Jun 2023.