TriangleNCT00436618 · OUTCOME
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients in group
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 5 years
What was measured
CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
Analysis population: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
Groups in this outcome
Relapsed Aggressive Non-Hodgkin Lymphoma
Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Relapsed Indolent Non-Hodgkin Lymphoma
Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Uncommon Lymphomas
Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
| Group | Source count |
|---|---|
| Relapsed Aggressive Non-Hodgkin Lymphoma | 114 |
| Relapsed Indolent Non-Hodgkin Lymphoma | 55 |
| Uncommon Lymphomas | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relapsed Aggressive Non-Hodgkin Lymphoma | 26 | Not reported | 19 | 35 | Not reported |
| Relapsed Indolent Non-Hodgkin Lymphoma | 35 | Not reported | 22 | 49 | Not reported |
| Uncommon Lymphomas | 49 | Not reported | 39 | 58 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19
- upper Limit
- 35
- value
- 26
- group Id
- OG001
- lower Limit
- 22
- upper Limit
- 49
- value
- 35
- group Id
- OG002
- lower Limit
- 39
- upper Limit
- 58
- value
- 49
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 107
- units
- Participants
- description
- CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG000
- title
- Relapsed Aggressive Non-Hodgkin Lymphoma
- description
- Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG001
- title
- Relapsed Indolent Non-Hodgkin Lymphoma
- description
- Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
- id
- OG002
- title
- Uncommon Lymphomas
- param Type
- NUMBER
- population Description
- 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.
- type
- PRIMARY
- unit Of Measure
- percentage of patients in group
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Preserved source evidence · Not medical advice