Trial · NCT01419795
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
NCT01419795, Phase 2, Terminated, Fred Hutchinson Cancer Center; results first posted 2017-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant. Trials, record NCT01419795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01419795
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
- NCT number
- NCT01419795
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia
- Interventions
- lenalidomide, rituximab, pharmacological study, laboratory biomarker analysis
- First posted
- 2011-08-18
- Last updated
- 2017-07-27
- Results first posted
- 2017-03-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1) | 12 months | Estimated using the Kaplan-Meier method in all cohorts. |
| Secondary | Rate of Response (CR, PR, or SD) and Time to Progression | Assessed up to 18 months | Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100. |
| Secondary | Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab | Assessed up to 30 days after completion of study treatment | |
| Secondary | Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | Assessed up to 30 days after completion of study treatment | |
| Secondary | Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts | Assessed up to 18 months | |
| Secondary | Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide | From baseline to day 28 of course 3 | |
| Secondary | Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts | Assessed up to 30 days after completion of study treatment | |
| Secondary | Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses | Baseline, day 7 and 28 of course 1, and day 28 of course 3 | |
| Secondary | Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse | Baseline, day 7 and 28 of course 1, and day 28 of course 3 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1) | 12 months | Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls. | survival probability | NUMBER |
| SECONDARY | Rate of Response (CR, PR, or SD) and Time to Progression | Assessed up to 18 months | No participants enrolled in the second arm. | progression free survival probability | NUMBER |
| SECONDARY | Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab | Assessed up to 30 days after completion of study treatment | No participants enrolled in the second arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | Assessed up to 30 days after completion of study treatment | No participants enrolled in the second arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts | Assessed up to 18 months | No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide | From baseline to day 28 of course 3 | With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected. | ||
| SECONDARY | Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts | Assessed up to 30 days after completion of study treatment | No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls. | Number of adverse events | NUMBER |
| SECONDARY | Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses | Baseline, day 7 and 28 of course 1, and day 28 of course 3 | With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected. | ||
| SECONDARY | Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse | Baseline, day 7 and 28 of course 1, and day 28 of course 3 | With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1) | Arm I (Lenalidomide, Rituximab) | 0.33 | 95% Confidence Interval 0.067 to 1.00 | survival probability | |
| Rate of Response (CR, PR, or SD) and Time to Progression | Arm I (Lenalidomide, Rituximab) | 0.67 | 95% Confidence Interval 0.30 to 1.00 | progression free survival probability | |
| Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab | Arm I (Lenalidomide, Rituximab) | 2 | Participants | ||
| Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD | Arm I (Lenalidomide, Rituximab) | 0 | Participants | ||
| Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts | Arm I (Lenalidomide, Rituximab) | 0 | Participants | ||
| Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts | Arm I (Lenalidomide, Rituximab) | 7 | Number of adverse events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Lenalidomide, Rituximab) | 3 | |
| Overall Study | STARTED | Arm II (Lenalidomide) | 0 | |
| Overall Study | COMPLETED | Arm I (Lenalidomide, Rituximab) | 3 | |
| Overall Study | COMPLETED | Arm II (Lenalidomide) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Lenalidomide, Rituximab) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Lenalidomide) | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Superior vena cava obstruction | Vascular disorders | Arm I (Lenalidomide, Rituximab) | 1 | 3 | 1 |
| serious | Superior vena cava obstruction | Vascular disorders | Arm II (Lenalidomide) | 0 | 0 | 0 |
| serious | Hyperglycemia | Metabolism and nutrition disorders | Arm I (Lenalidomide, Rituximab) | 1 | 3 | 1 |
| serious | Hyperglycemia | Metabolism and nutrition disorders | Arm II (Lenalidomide) | 0 | 0 | 0 |
| serious | Dehydration | Metabolism and nutrition disorders | Arm I (Lenalidomide, Rituximab) | 1 | 3 | 1 |
| serious | Dehydration | Metabolism and nutrition disorders | Arm II (Lenalidomide) | 0 | 0 | 0 |
| serious | Tumor flare syndrome | Metabolism and nutrition disorders | Arm I (Lenalidomide, Rituximab) | 1 | 3 | 1 |
| serious | Tumor flare syndrome | Metabolism and nutrition disorders | Arm II (Lenalidomide) | 0 | 0 | 0 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm I (Lenalidomide, Rituximab) | 1 | 3 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm II (Lenalidomide) | 0 | 0 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Lenalidomide, Rituximab) | ||
| Total, all-cause mortality | Arm II (Lenalidomide) | ||
| Total, other adverse events | Arm I (Lenalidomide, Rituximab) | 0 | 3 |
| Total, other adverse events | Arm II (Lenalidomide) | 0 | 0 |
| Total, serious adverse events | Arm I (Lenalidomide, Rituximab) | 2 | 3 |
| Total, serious adverse events | Arm II (Lenalidomide) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT01419795
GET https://conductscience.org/api/trials/v1/NCT01419795/registered