Trial · NCT00089284
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
NCT00089284, Phase 1, Phase 2, Terminated, Northwestern University; results first posted 2019-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL. Trials, record NCT00089284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
- NCT number
- NCT00089284
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Interventions
- Rituxan, motexafin gadolinium, 111Indium-Zevalin and 90Yttrium-Zevalin
- First posted
- 2004-08-05
- Last updated
- 2019-08-14
- Results first posted
- 2019-08-14
- Limitations and caveats
- Due to a lack of adequate funding, we were unable to complete 2 of the secondary objectives for this study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLT) | Weekly during treatment and continuing up through Day 90 | The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively). |
| Primary | Maximum Tolerated Dose (MTD) | Weekly during treatment and continuing up through Day 90 | The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients. |
| Secondary | Anti-lymphoma Efficacy | At 1, 3 and 6 months | To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined. |
| Secondary | Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs | At baseline (pre-treatment) and on Day 4 of treatment | To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement. |
| Secondary | Correlative Laboratory Studies | On Day 1 and 4 | To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Limiting Toxicities (DLT) | Weekly during treatment and continuing up through Day 90 | Only patients enrolled during the phase I portion of this trial were analyzed for this outcome measure. | Dose-Limiting Toxicities | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) | Weekly during treatment and continuing up through Day 90 | Phase I arms were evaluable for this outcome measure. | mg/kg | NUMBER |
| SECONDARY | Anti-lymphoma Efficacy | At 1, 3 and 6 months | All phase I and phase II patients were evaluated for response to treatment (anti-lymphoma efficacy). For the cohort with ≤ 5% bone marrow involvement treated at the 5.0 mg/kg MGd dose, results are based on 6 phase I patients and 8 phase II patients. 2 patients were determined not to be evaluable as they did not reach response time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs | At baseline (pre-treatment) and on Day 4 of treatment | Data was not collected for analysis of this outcome measure due to lack of funding. | ||
| SECONDARY | Correlative Laboratory Studies | On Day 1 and 4 | Data not collected for analysis of this outcome measure. |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Limiting Toxicities (DLT) | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | Dose-Limiting Toxicities | ||
| Dose Limiting Toxicities (DLT) | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | Dose-Limiting Toxicities | ||
| Dose Limiting Toxicities (DLT) | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | Dose-Limiting Toxicities | ||
| Dose Limiting Toxicities (DLT) | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | Dose-Limiting Toxicities | ||
| Maximum Tolerated Dose (MTD) | Rituxan and 90Yttrium-Zevalin Plus MGd | 5.0 | mg/kg | ||
| Anti-lymphoma Efficacy | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Complete Response (CR) | 6 | Participants | |
| Anti-lymphoma Efficacy | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | Complete Response (CR) | 0 | Participants | |
| Anti-lymphoma Efficacy | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Complete Response (CR) | 2 | Participants | |
| Anti-lymphoma Efficacy | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Complete Response (CR) | 3 | Participants | |
| Anti-lymphoma Efficacy | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Partial Response (PR) | 0 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 7 | |
| Overall Study | STARTED | Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 3 | |
| Overall Study | STARTED | Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 6 | |
| Overall Study | STARTED | Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 6 | |
| Overall Study | STARTED | Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | |
| Overall Study | STARTED | Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | |
| Overall Study | STARTED | Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement | 8 | |
| Overall Study | COMPLETED | Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 7 | |
| Overall Study | COMPLETED | Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 3 | |
| Overall Study | COMPLETED | Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events420
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 | Alkaline phosphatase | Metabolism and nutrition disorders | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 2 | 7 | 2 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 2 | 3 | 2 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | 6 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 5 | 13 | 5 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | 0 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | 0 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | 7 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 0 | 3 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 0 | 6 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 1 | 13 | 1 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | ||
| Total, all-cause mortality | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | ||
| Total, all-cause mortality | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | ||
| Total, all-cause mortality | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | ||
| Total, all-cause mortality | 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | ||
| Total, all-cause mortality | 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | ||
| Total, other adverse events | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 7 | 7 |
| Total, other adverse events | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | 3 | 3 |
| Total, other adverse events | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 6 | 6 |
| Total, other adverse events | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | 13 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00089284
GET https://conductscience.org/api/trials/v1/NCT00089284/results?page=2