Clinical trial · Interventional
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to lack of funding, phase II of study was not completed.
Summary
Brief summary (as posted)
Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 111Indium-Zevalin and 90Yttrium-Zevalin | Drug | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
| Rituxan | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituxan and 90Yttrium-Zevalin plus MGd
- description
- Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2\*, 4\*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
- interventionNames
- Drug: Rituxan
- Drug: motexafin gadolinium
- Drug: 111Indium-Zevalin and 90Yttrium-Zevalin
Primary outcomes (2)
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
- Weekly during treatment and continuing up through Day 90
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of one of the following:
* Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)
* The following histologies are eligible:
* Small lymphocytic lymphoma
* Lymphoplasmacytoid lymphoma
* Follicular center grades 1, 2, or 3 lymphoma
* Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type
* Nodal marginal zone B-cell lymphoma
* Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline regimen
* Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse
* Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell lymphoma, with no more than 1 relapse since transformation
Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months Recovered from prior chemotherapy
* More than 4 weeks since prior major surgery and recovered
* More than 4 weeks since prior anticancer therapy recovered from prior radiotherapy
Exclusion criteria:
No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks
* No active infection
* No other active nonmalignant disease
* No known G6PD deficiency
* No history of porphyria
* No other condition that would preclude study participation
* No human anti-mouse antibodies
* No known history of HIV
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior radioimmunoconjugate therapy
* No prior exposure to murine antibodies other than rituximab
* More than 4 weeks since prior rituximab
* No history of failed stem cell collectionReferences
Publications (0)
Data not yet available