Trial · NCT00422656
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
NCT00422656, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2012-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia. Trials, record NCT00422656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
- NCT number
- NCT00422656
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom's Macroglobulinemia
- Interventions
- Perifosine
- First posted
- 2007-01-17
- Last updated
- 2017-12-26
- Results first posted
- 2012-02-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response (OR) Rate | 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+). | 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. |
| Secondary | Time to Progression (TTP) | 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. | 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. |
| Secondary | Progression Free Survival (PFS) | 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. | 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. |
| Secondary | Treatment-Related Grade 3-4 Adverse Event Rate | Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). | The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response (OR) Rate | 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+). | The analysis dataset is comprised of all enrolled patients. | percentage of patients | NUMBER |
| SECONDARY | Time to Progression (TTP) | 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. | The analysis dataset is comprised of all enrolled patients. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | 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. | The analysis dataset is comprised of all enrolled patients. | months | MEDIAN |
| SECONDARY | Treatment-Related Grade 3-4 Adverse Event Rate | Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). | The analysis dataset is comprised of all enrolled patients. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response (OR) Rate | Perifosine | 38 | 90% Confidence Interval 25 to 53 | percentage of patients | |
| Time to Progression (TTP) | Perifosine | 12.6 | 90% Confidence Interval 10.2 to 22.7 | months | |
| Progression Free Survival (PFS) | Perifosine | 12.6 | 90% Confidence Interval 10.2 to 22.7 | months | |
| Treatment-Related Grade 3-4 Adverse Event Rate | Perifosine | 35 | 90% Confidence Interval 22 to 50 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perifosine | 37 | |
| Overall Study | COMPLETED | Perifosine | 37 | |
| Overall Study | NOT COMPLETED | Perifosine | 0 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | Perifosine | 2 | 37 | |
| other | Infection Gr0-2 neut, eye NOS | Infections and infestations | Perifosine | 1 | 37 | |
| other | Infection Gr0-2 neut, lung | Infections and infestations | Perifosine | 1 | 37 | |
| other | Infection Gr0-2 neut, skin | Infections and infestations | Perifosine | 1 | 37 | |
| other | Infection Gr0-2 neut, upper airway | Infections and infestations | Perifosine | 1 | 37 | |
| other | Infection w/ unk ANC oral cavity/gums | Infections and infestations | Perifosine | 1 | 37 | |
| other | Infection w/ unk ANC upper airway NOS | Infections and infestations | Perifosine | 1 | 37 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Perifosine | 26 | 37 | |
| other | Palpitations | Cardiac disorders | Perifosine | 2 | 37 | |
| other | Hearing-other | Ear and labyrinth disorders | Perifosine | 1 | 37 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perifosine | 0 | 37 |
| Total, other adverse events | Perifosine | 37 | 37 |
| Total, serious adverse events | Perifosine | 14 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20103671 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00422656
GET https://conductscience.org/api/trials/v1/NCT00422656/events?page=2