Trial · NCT01182415
High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma
NCT01182415, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma. Trials, record NCT01182415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01182415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma
- NCT number
- NCT01182415
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Non-Hodgkin's Lymphoma, CNS Lymphoma
- Interventions
- Autologous stem cell transplant, High-dose chemotherapy
- First posted
- 2010-08-16
- Last updated
- 2023-04-06
- Results first posted
- 2017-12-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year | 3 years | The proportion of patients with central nervous system (CNS) involvement by B-cell Non-Hodgkin's Lymphoma (NHL), relapsed primary central nervous system lymphoma (PCNSL), or relapsed primary intraocular lymphoma (PIOL) who are alive and progression-free at one year. Relapse was defined as per standard PCNSL criteria from clinical and MRI criteria. |
| Secondary | 2-year Progression Free Survival (PFS) | 2 years | The percentage of participants alive and without disease progression at 2 years. Disease progression was judged through clinical impression and MRI imaging. |
| Secondary | 2-year Overall Survival (OS) | 2 years | The percentage of participants alive after two years |
| Secondary | Response Rate | 3 years | The number of participants that achieved complete remission following high dose chemotherapy and autologous stem cell transplantation (ASCT). Complete remission is defined as the disappearance of all evidence of disease. Response was judged by MRI assessment. |
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 | Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year | 3 years | The participant that was lost to follow-up was not available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 2-year Progression Free Survival (PFS) | 2 years | The participant that was lost to follow-up was not available for analysis. | percentage of participants | NUMBER |
| SECONDARY | 2-year Overall Survival (OS) | 2 years | The participant that was lost to follow-up was not available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Response Rate | 3 years | The participant that was lost to follow-up was not available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year | High-dose Chemotherapy With Autologous Stem Cell Transplant | 28 | Participants | ||
| 2-year Progression Free Survival (PFS) | High-dose Chemotherapy With Autologous Stem Cell Transplant | 81 | 95% Confidence Interval 59 to 92 | percentage of participants | |
| 2-year Overall Survival (OS) | High-dose Chemotherapy With Autologous Stem Cell Transplant | 93 | 95% Confidence Interval 76 to 98 | percentage of participants | |
| Response Rate | High-dose Chemotherapy With Autologous Stem Cell Transplant | 29 | Participants |
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 | High-dose Chemotherapy With Autologous Stem Cell Transplant | 30 | |
| Overall Study | COMPLETED | High-dose Chemotherapy With Autologous Stem Cell Transplant | 29 | |
| Overall Study | NOT COMPLETED | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 |
Source ClinicalTrials.gov
Adverse events15
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 |
|---|---|---|---|---|---|---|
| serious | Anemia | Blood and lymphatic system disorders | High-dose Chemotherapy With Autologous Stem Cell Transplant | 2 | 30 | 2 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Gait disturbance | General disorders | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Mucositis oral | Gastrointestinal disorders | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Lung infection | Infections and infestations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Alanine aminotransferase increased | Investigations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Aspartate aminotransferase increased | Investigations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
| serious | Lymphocyte count decreased | Investigations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 2 |
| serious | Platelet count decreased | Investigations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 2 | 30 | 2 |
| serious | Investigations - Other, specify | Investigations | High-dose Chemotherapy With Autologous Stem Cell Transplant | 1 | 30 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High-dose Chemotherapy With Autologous Stem Cell Transplant | 3 | 30 |
| Total, other adverse events | High-dose Chemotherapy With Autologous Stem Cell Transplant | 0 | 30 |
| Total, serious adverse events | High-dose Chemotherapy With Autologous Stem Cell Transplant | 6 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25204639 | RESULT |
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/NCT01182415
GET https://conductscience.org/api/trials/v1/NCT01182415/registered