An observational study in Carcinoma, Renal Cell and Lymphoma, Mantle-Cell, sponsored by Pfizer. Completed at 16 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-27.
Sponsored by Pfizer · Observational
The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.
There is not sampling method
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This study's enrollment of 243 is above the median of 136 across 625 observational studies indexed under Lymphoma.
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Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Exclusion Criteria:
Patients that do not have a minimum (pre-specified) of data in their clinical record.
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Other: Temsirolimus (Non-Interventional Study)
There is not any intervention in this study.
Progression-free Survival (PFS)
Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Percentage of Participants With Objective Response
Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to \<10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was \>1.5 cm in longest transverse dimension regressed to \<=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to \<=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Duration of Response (DOR)
Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.
Time frame: From initiation of treatment up to disease progression (up to 80 months)
Overall Survival (OS)
Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.
Time frame: From initiation of treatment untill death (up to 80 months)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Time frame: Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
| Milestone | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab |
|---|---|---|---|
| Started | 193 | 23 | 26 |
| Completed | 5 | 23 | 26 |
| Not completed | 188 | 0 | 0 |
| Withdrew: Death | 2 | 0 | 0 |
| Withdrew: Investigator's decision | 2 | 0 | 0 |
| Withdrew: Clinical decline (cd) | 2 | 0 | 0 |
| Withdrew: Progression and death | 8 | 0 | 0 |
| Withdrew: Toxicity | 16 | 0 | 0 |
| Withdrew: Progression | 137 | 0 | 0 |
| Withdrew: Patient asks for rest + slow progression | 1 | 0 | 0 |
| Withdrew: Investigator's opinion, stable disease | 1 | 0 | 0 |
| Withdrew: Bleeding from cavernous haemangioma | 1 | 0 | 0 |
| Withdrew: 3 yr temsirolimus treatment (no disease) | 1 | 0 | 0 |
| Withdrew: Low grade toxicities + stable disease | 1 | 0 | 0 |
| Withdrew: Choledocolithiasis and pancreatitis | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Cd, associated leukaemia | 1 | 0 | 0 |
| Withdrew: Uncontrolled pain | 1 | 0 | 0 |
| Withdrew: Overall status worsens to grade 4 | 1 | 0 | 0 |
| Withdrew: Stabilisation + frequent infections | 1 | 0 | 0 |
| Withdrew: No clinical benefit | 1 | 0 | 0 |
| Withdrew: Intestinal obstruction with necrosis | 1 | 0 | 0 |
| Withdrew: Overall decline | 1 | 0 | 0 |
| Withdrew: Rejection of treatment | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Death from septic shock | 1 | 0 | 0 |
| Withdrew: Cd, suspected disease progression (dp) | 1 | 0 | 0 |
| Withdrew: Patient's wish | 1 | 0 | 0 |
| Withdrew: Palliative. overall decline | 1 | 0 | 0 |
| Withdrew: Suspected dp/suspected active infection | 1 | 0 | 0 |
Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.
| months | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Progression-free Survival (PFS) | 4.04 (3.03 to 5.05) | 7.467 (4.171 to 10.763) | 13.233 (3.306 to 23.161) |
Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to \<10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was \>1.5 cm in longest transverse dimension regressed to \<=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to \<=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)
| percentage of participants | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| CR | 0.5 | 34.8 | 30.8 |
| PR | 14.3 | 17.4 | 50.0 |
| SD | 46.6 | 26.1 | 7.7 |
| DP | 38.6 | 21.7 | 11.5 |
Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.
| months | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Duration of Response (DOR) | 13.21 (8.55 to 17.87) | 7.28 (4.23 to 9.85) | 8.82 (6.42 to 13.16) |
Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.
| months | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| Overall Survival (OS) | 10.81 (8.20 to 13.42) | 19.233 (3.052 to 35.415) | 18.667 (NA to NA) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).
| participants | RCC: Temsirolimus | MCL: Temsirolimus | MCC: Temsirolimus + Rituximab |
|---|---|---|---|
| AEs | 145 | 19 | 16 |
| SAEs | 18 | 3 | 7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RCC: Temsirolimus | — | 18/193 (9.3%) | 142/193 (73.6%) |
| MCL: Temsirolimus | — | 3/23 (13%) | 18/23 (78.3%) |
| MCL: Temsirolimus + Rituximab | — | 7/26 (26.9%) | 14/26 (53.8%) |
| Event | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab |
|---|---|---|---|
| OthersGeneral disorders | 1/193 | 0/23 | 2/26 |
| GastroenteritisInfections and infestations | 0/193 | 1/23 | 0/26 |
| PneumoniaInfections and infestations | 0/193 | 1/23 | 1/26 |
| NeutropeniaBlood and lymphatic system disorders | 0/193 | 1/23 | 0/26 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/193 | 0/23 | 1/26 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 0/193 | 0/23 | 1/26 |
| Aspergillus infectionInfections and infestations | 0/193 | 0/23 | 1/26 |
| Respiratory tract infectionInfections and infestations | 0/193 | 0/23 | 1/26 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/193 | 0/23 | 1/26 |
| Atrioventricular block completeCardiac disorders | 0/193 | 0/23 | 1/26 |
| Event | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 11/193 | 12/23 | 5/26 |
| AnaemiaBlood and lymphatic system disorders | 58/193 | 4/23 | 3/26 |
| AstheniaGeneral disorders | 43/193 | 4/23 | 1/26 |
| StomatitisGastrointestinal disorders | 41/193 | 1/23 | 1/26 |
| DiarrhoeaGastrointestinal disorders | 13/193 | 3/23 | 4/26 |
| RashSkin and subcutaneous tissue disorders | 26/193 | 2/23 | 3/26 |
| HyperglycaemiaMetabolism and nutrition disorders | 23/193 | 3/23 | 2/26 |
| NeutropeniaBlood and lymphatic system disorders | 4/193 | 1/23 | 3/26 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 19/193 | 2/23 | 0/26 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 17/193 | 2/23 | 2/26 |
Baseline population included all participants with RCC or MCL who received atleast 1 dose of study treatment.
| Age, Continuous(years) | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | Total |
|---|---|---|---|---|
| Mean | 65.27 ± 11.14 | 70.56 ± 11.07 | 72.34 ± 7.11 | 66.54 ± 11.04 |
| Sex: Female, Male(Participants) | RCC: Temsirolimus | MCL: Temsirolimus | MCL: Temsirolimus + Rituximab | Total |
|---|---|---|---|---|
| Female | 57 | 3 | 3 | 63 |
| Male | 136 | 20 | 23 | 179 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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