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A Pivotal Study to Determine the Safety and Efficacy of Using B-Cell High Density Microparticles (BCell-HDM) to Deplete B-Cells From Peripheral Blood Stem Cell Collections Without Compromising the Time to Neutrophil and Platelet Engraftment in Patients With Relapsed Low or Intermediate Grade B-Cell Non-Hodgkin's Lymphoma Given Autologous Peripheral Blood Stem Cell Transplants After High-Dose Chemotherapy


Phase 2
18 Years
65 Years
Not Enrolling
Both
Lymphoma

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Trial Information

A Pivotal Study to Determine the Safety and Efficacy of Using B-Cell High Density Microparticles (BCell-HDM) to Deplete B-Cells From Peripheral Blood Stem Cell Collections Without Compromising the Time to Neutrophil and Platelet Engraftment in Patients With Relapsed Low or Intermediate Grade B-Cell Non-Hodgkin's Lymphoma Given Autologous Peripheral Blood Stem Cell Transplants After High-Dose Chemotherapy


OBJECTIVES: I. Determine the effectiveness of the B-cell high density microparticles
(BCell-HDM) device in purging B-cells from peripheral blood stem cells (PBSC) harvested from
patients with relapsed low or intermediate grade B-cell non-Hodgkin's lymphoma. II.
Determine the recovery of T-cells and CD34+ cells in BCell-HDM processed PBSC in these
patients. III. Compare hematopoietic engraftment following infusion of autologous PBSC
purged using the BCell-HDM device versus unpurged autologous PBSC in these patients
receiving high dose chemotherapy. IV. Determine the toxicity of this regimen in these
patients. V. Determine the occurrence of adverse effects from this regimen in these
patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by
grade of lymphoma (low vs intermediate), type of myeloablative conditioning regimen
(chemotherapy only vs chemotherapy/total body irradiation), and center. Patients are
randomized to one of two treatment arms. Patients undergo peripheral blood stem cell (PBSC)
harvest over no more than 4 consecutive days. A myeloablative conditioning regimen of either
chemotherapy alone or chemotherapy/total body irradiation is given within 4 weeks of PBSC
harvest. Prior to randomization one patient at each center receives PBSC transplantation
using cells purged with the B-cell high density microparticle (BCell-HDM) device. Arm I:
Patients receive BCell-HDM treated PBSC transplantation on day 0. Arm II: Patients receive
untreated PBSC transplantation on day 0. Patients receive filgrastim (G-CSF) subcutaneously
beginning on day 1 and continuing until blood counts recover. Patients are followed on days
30 and 100, and then at 6 and 12 months.

PROJECTED ACCRUAL: A total of 115 patients (15 for prerandomization study, 50 for each
treatment arm) will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William I. Bensinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1488.00

NCT ID:

NCT00006241

Start Date:

March 2000

Completion Date:

October 2000

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109