NCT00006241

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Treating the peripheral stem cells in the laboratory to remove any existing cancer cells may improve the effectiveness of the transplant. PURPOSE: Randomized phase II trial to compare the effectiveness of treated peripheral stem cells with that of untreated stem cells in patients who have relapsed low- or intermediate-grade non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2000

Shorter than P25 for phase_2 lymphoma

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

June 22, 2004

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

September 11, 2000

Last Update Submit

November 28, 2011

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

filgrastimBIOLOGICAL
chemotherapyDRUG
in vitro-treated peripheral blood stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of relapsed low or intermediate grade B-cell non-Hodgkin's lymphoma CD20+ or CD19+ tumor cells Bone marrow involvement less than 20% of intratrabecular space All tumor masses less than 5 cm in each dimension In second or greater remission with either complete remission or minimal disease state OR Failed to achieve remission with primary induction therapy, but can achieve minimal disease with additional chemotherapy or radiotherapy OR Persistent splenomegaly with otherwise minimal disease No active CNS involvement 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: 18 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 50% predicted Other: Not pregnant Negative pregnancy test No prior other malignancy except carcinoma in situ of the cervix or basal cell carcinoma of the skin No known hypersensitivity to nickel No known hypersensitivity to mouse proteins HIV negative HTLV I and II negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior unconjugated anti-B-cell monoclonal antibody (mAb) (e.g., rituximab, Campath I) No prior anti-B-cell mAb conjugated to radioisotopes such as iodine I 131 (e.g., iodine I monoclonal antibody anti-B1) or yttrium Y No concurrent mAb therapy until 12 months after study No other biologic therapy (e.g., monoclonal antibodies, interferon alfa) for 12 months after study No concurrent hematopoietic growth factors other than filgrastim (G-CSF) Chemotherapy: See Disease Characteristics No chemotherapy within 5 days prior to PBSC collection No other concurrent chemotherapy for 12 months after study Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy for 12 months after study Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimDrug TherapyPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTherapeuticsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • William I. Bensinger, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

June 22, 2004

Study Start

March 1, 2000

Study Completion

October 1, 2000

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)