Clinical trial · Interventional
Biological Therapy After Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas
NCT00012207CI-TRIAL-00003832completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr
Secondary outcomes (4)
- measure
- Duration of in vivo persistence of adoptively transferred CD20-specific CD8+ T cell clones by flow cytometry and quantitative polymerase chain reaction (qPCR) during each infusion, weekly for 4 weeks, and then monthly for a year
- measure
- Trafficking of CD8+ CD20-specific T cell clones to lymph nodes by Gamma camera imaging during each infusion, weekly for 4 weeks, and then monthly for a year
- measure
- Development of host anti-scFvFc:zeta (and anti-NeoR) immune responses by ELISA and chromium release assays during each infusion, weekly for 4 weeks, and then monthly for a year
- measure
- Tumor responses to cyclophosphamide, vincristine, and prednisone (CVP) and to cytotoxic T-lymphocyte (CTL) infusions by Cheson criteria during each infusion, weekly for 4 weeks, and then monthly for a year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma
* Indolent B-cell lymphomas including any of the following subtypes:
* Follicular lymphoma (grade I, II, or III)
* Small lymphocytic lymphoma or chronic lymphocytic leukemia
* Marginal zone lymphoma (splenic, nodal, and extra-nodal)
* Lymphoplasmacytoid lymphoma
* Ineligible for or unwilling to participate in other FHCRC/UWMC protocols
* Serological evidence of prior exposure to Epstein-Barr virus
* Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node biopsy, and nuclear medicine imaging
* Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to \< 5 cm in diameter or circulating B lymphocyte counts to \< 5,000/mm\^3
* No pulmonary involvement
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* Not specified
Life expectancy:
* At least 90 days
Hematopoietic:
* Not specified
Hepatic:
* No active hepatitis B infection
Renal:
* Not specified
Other:
* No HIV positivity
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of hypersensitivity reactions to murine proteins
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 months since prior rituximab, tositumomab, or ibritumomab
* No prior allogeneic stem cell transplantation
* No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products)
Chemotherapy:
* At least 2 years since prior fludarabine or cladribine
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* At least 4 weeks since prior immunosuppressive therapy and recovered
* No concurrent pentoxifylline
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTTill BG, Jensen MC, Wang J, Chen EY, Wood BL, Greisman HA, Qian X, James SE, Raubitschek A, Forman SJ, Gopal AK, Pagel JM, Lindgren CG, Greenberg PD, Riddell SR, Press OW. Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells. Blood. 2008 Sep 15;112(6):2261-71. doi: 10.1182/blood-2007-12-128843. Epub 2008 May 28. PMID 18509084