TriangleNCT00422656 · STUDY IN CONTEXT
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protein and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan; and MR: At least 25% but less than 50% reduction of IgM M-protein by protein electrophoresis. Patients must have no new symptoms or signs of active disease.
TTP estimated using the Kaplan-Meier method is defined as the time from registration to disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.
PFS estimated using the Kaplan-Meier method is defined as the time from registration to death from any cause or disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients alive without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.
The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- trial label
- Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0000
- source section id
- NCT00422656-om-0000
- source outcome index
- 0
- endpoint
- Overall Response (OR) Rate
- endpoint definition
- OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protein and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan; and MR: At least 25% but less than 50% reduction of IgM M-protein by protein electrophoresis. Patients must have no new symptoms or signs of active disease.
- time origin
- Disease was assessed every cycle for the first 12 months and every 3 months thereafter. The median duration of treatment with perifosine was 5.6 months (range, 1.8- 21.5+).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0001
- source section id
- NCT00422656-om-0001
- source outcome index
- 1
- endpoint
- Time to Progression (TTP)
- endpoint definition
- TTP estimated using the Kaplan-Meier method is defined as the time from registration to disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.
- time origin
- Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0002
- source section id
- NCT00422656-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS estimated using the Kaplan-Meier method is defined as the time from registration to death from any cause or disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients alive without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.
- time origin
- Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0003
- source section id
- NCT00422656-om-0003
- source outcome index
- 3
- endpoint
- Treatment-Related Grade 3-4 Adverse Event Rate
- endpoint definition
- The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.
- time origin
- Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Perifosine
- regimen
- Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00422656-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Perifosine
- regimen
- Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00422656-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Perifosine
- regimen
- Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00422656-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Perifosine
- regimen
- Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00422656-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-indolent-b-cell-non-hodgkin-lymphoma-recurrent-7342020a
- nct id
- NCT00422656
- harm key
- EG000
- source section id
- NCT00422656-ae
- event group key
- EG000
- event group label
- Perifosine
- serious affected
- 14
- serious at risk
- 37
- other affected
- 37
- other at risk
- 37
- frequency threshold
- 1
- collection period
- Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).
- event definition
- Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice