NCT00182650

Brief Summary

RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated in the laboratory to stimulate the immune system in different ways and stop cancer cells from growing. Rituximab and fludarabine may also prevent the body from making an immune response against the laboratory-treated white blood cells that are put back into the body. Interleukin-2 may help the laboratory-treated white blood cells stay in the body longer. Giving cellular adoptive immunotherapy together with rituximab, fludarabine, and interleukin-2 may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

Enrollment Period

3.8 years

First QC Date

September 15, 2005

Last Update Submit

December 23, 2009

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphoma

Interventions

aldesleukinBIOLOGICAL
rituximabBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
fludarabine phosphateDRUG

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin's lymphoma (NHL) * High-risk disease, as defined by any of the following: * Relapsed within 6 months after the last treatment * Failed to achieve a complete response during the last treatment * Relapsed after prior autologous hematopoietic stem cell transplantation (HSCT) * No current transformation of lymphoma (e.g., elements of intermediate- or high-grade lymphoma by biopsy) * No active CNS disease by lumbar puncture or radiology scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * 16 to 70 Performance status * Karnofsky 50-100% Life expectancy * More than 16 weeks Hematopoietic * Absolute neutrophil count \> 500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN)\* (unless due to Gilbert's disease) * ALT ≤ 2.5 times ULN\* NOTE: \*Unless due to NHL Renal * Creatinine ≤ 1.5 times ULN\* OR * Creatinine clearance ≥ 80 mL/min\* NOTE: \*Unless due to NHL Immunologic * HIV negative * Epstein-Barr virus positive * No history of allergy or intolerance to ganciclovir Other * Negative pregnancy test * No history of another malignancy except basal cell skin cancer or carcinoma in situ * No other uncontrolled or severe illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior allogeneic HSCT * No other immunotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the Principal Investigator (PI) Chemotherapy * No other chemotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the PI * Patients may receive chemotherapy after leukapheresis while waiting for CD19-specific T cells to be manufactured Endocrine therapy * No systemic corticosteroids during and for approximately 65 days after the last T-cell infusion, unless approved by the PI Radiotherapy * Not specified Surgery * Not specified Other * No concurrent participation in another investigational study * No immunosuppression agents or other investigational agents during and for approximately 65 days after the last T-cell infusion, unless approved by the PI

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

aldesleukinRituximabfludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations

US(1)