Study Stopped
Slow accrual.
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
3 other identifiers
interventional
4
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lymphoma
Started Jan 2006
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2003
CompletedFirst Posted
Study publicly available on registry
October 7, 2003
CompletedStudy Start
First participant enrolled
January 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
February 8, 2013
CompletedJune 29, 2023
June 1, 2023
3.1 years
October 3, 2003
January 7, 2013
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Assessed every 3 months for 2 years, then every 6 months for 1 year.
Study Arms (1)
Cyclosporine
EXPERIMENTALHigh 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504, United States
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, 60402, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Saint Joseph Hospital
Chicago, Illinois, 60657, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
La Grange Oncology Associates - Geneva
Naperville, Illinois, 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Ranjana Advani, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2003
First Posted
October 7, 2003
Study Start
January 24, 2006
Primary Completion
March 1, 2009
Study Completion
May 1, 2011
Last Updated
June 29, 2023
Results First Posted
February 8, 2013
Record last verified: 2023-06