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Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkin's Lymphoma


Phase 2
12 Years
65 Years
Not Enrolling
Both
Lymphoma

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Trial Information

Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkin's Lymphoma


OBJECTIVES:

- Compare the effects of mobilization therapy with or without rituximab on hematopoietic
stem cells, B and T lymphocytes, and natural killer cells in patients with advanced or
recurrent B-cell non-Hodgkin's lymphoma.

- Compare the effects of B-lymphocyte purging using concurrent rituximab and mobilization
therapy vs a CD34+ cell enrichment device on hematopoietic stem cells, B and T
lymphocytes, and natural killer cells in the peripheral blood stem cell (PBSC)
infusates.

- Compare the effect of these purging regimens on tumor cell content of PBSC infusates.

- Compare the effects of these regimens on myeloid and lymphoid engraftment after
high-dose chemotherapy and autologous PBSC infusion in these patients.

- Compare post-transplantation infection complications in patients treated with these
regimens.

- Compare the response and relapse-free survival of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive mobilization therapy comprising rituximab IV over 2-5 hours on
days 1, 8, and 15 and cyclophosphamide IV over 3-6 hours on day 16. Beginning 36-48
hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF)
subcutaneously (SC) daily until blood counts recover. Patients then undergo peripheral
blood stem cell (PBSC) collection.

After completion of PBSC collection, patients receive high-dose chemotherapy comprising
carmustine IV on days -7 to -3 and etoposide IV and cisplatin IV for 3 days during days -7
to -3. Patients may undergo involved-field radiotherapy to active or previously bulky (more
than 5 cm) tumors daily for 7-10 days.

Patients receive unmanipulated PBSCs on day 0. Patients receive G-CSF SC daily beginning 4
hours after completion of PBSC infusion and continuing until neutrophil engraftment.

- Arm II: Patients receive mobilization therapy comprising cyclophosphamide and G-CSF and
high-dose chemotherapy comprising carmustine, etoposide, and cisplatin as in arm I.
Patients may also undergo involved-field radiotherapy as in arm I. Patients receive
CD34 cell-enriched PBSC on day 0 followed by G-CSF as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL)

- Indolent or aggressive histology

- No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic
non-Burkitt's lymphoma

- CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry

- Second or greater remission allowed

- Partial remission, relapse, or refractory disease must have measurable tumor

- Eligible for high-dose therapy followed by autologous peripheral blood stem cell
transplantation

- No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

- 12 to 65

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,200/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

Renal:

- Creatinine clearance at least 60 mL/min

- No renal dysfunction

Cardiovascular:

- LVEF at least 40%

- No cardiac dysfunction

- No myocardial infarction within the past 3 months

Pulmonary:

- FEV_1 greater than 60%

- DLCO at least 60% of predicted

- No pulmonary dysfunction

- No asthma

Other:

- HIV negative

- No significant organ dysfunction

- No severe comorbid condition

- No uncontrolled diabetes

- No severe or active infection

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Chemotherapy

- No prior immunotherapy

Chemotherapy:

- No prior high-dose chemotherapy with or without peripheral blood stem cell
transplantation

- No more than 3 prior chemotherapy regimens for NHL

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Total CD34 cells

Outcome Time Frame:

measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant

Safety Issue:

No

Principal Investigator

Omer N. Koc, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1499

NCT ID:

NCT00028665

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic 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 adult immunoblastic large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106