Trial Outcomes & Findings for Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma (NCT NCT00070291)
NCT ID: NCT00070291
Last Updated: 2023-06-29
Results Overview
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.
TERMINATED
PHASE2
4 participants
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.
2023-06-29
Participant Flow
Participants were recruited from ECOG member institutions between September 2, 2005 and March 24, 2009. The first patient was accrued on January 24, 2006. The study was terminated due to slow accrual.
Participant milestones
| Measure |
Cyclosporine
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) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
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.
|
|---|---|
|
Step 1
STARTED
|
4
|
|
Step 1
Treated
|
3
|
|
Step 1
COMPLETED
|
2
|
|
Step 1
NOT COMPLETED
|
2
|
|
Step 2
STARTED
|
1
|
|
Step 2
COMPLETED
|
0
|
|
Step 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cyclosporine
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) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
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.
|
|---|---|
|
Step 1
Withdrawal by Subject
|
1
|
|
Step 1
Adverse Event
|
1
|
|
Step 2
Adverse Event
|
1
|
Baseline Characteristics
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cyclosporine
n=4 Participants
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: all 4 enrolled patients
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.
Outcome measures
| Measure |
Cyclosporine
n=4 Participants
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) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
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.
|
|---|---|
|
Response Rate (Complete and Partial Response)
|
0.25 Proportion of participants
Interval 0.007 to 0.81
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 year.Population: all 4 enrolled patients
Overall survival was defined as time from randomization to death from any cause.
Outcome measures
| Measure |
Cyclosporine
n=4 Participants
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) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.
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.
|
|---|---|
|
Overall Survival
|
36 Months
Interval 5.0 to 36.0
|
Adverse Events
Cyclosporine
Serious adverse events
| Measure |
Cyclosporine
n=3 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Hematologic-other
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Cyclosporine
n=3 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukopenia (Leukocytes, decreased)
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutropenia (Neutrophils, decreased)
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Thrombocytopenia (Platelets, decreased)
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema limb
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine, increased
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Metabolic/Laboratory-other
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Head/headache
|
66.7%
2/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place