Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cyclophosphamide With or Without Rituximab and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	12 to 65	NCI	CWRU-1499 CWRU-030040, NCI-G01-2040, NCT00028665, CASE-1499

Objectives

1. 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.
2. 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.
3. Compare the effect of these purging regimens on tumor cell content of PBSC infusates.
4. Compare the effects of these regimens on myeloid and lymphoid engraftment after high-dose chemotherapy and autologous PBSC infusion in these patients.
5. Compare post-transplantation infection complications in patients treated with these regimens.
6. Compare the response and relapse-free survival of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• 12 to 65

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,200/mm³
• Platelet count greater than 100,000/mm³

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:

• FEV₁ 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

Expected Enrollment

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

Outcomes

Total CD34 cells measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
T and B lymphocyte counts measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
Disease response measured at 4 weeks after the transplant
Engraftment measured at days 42 and 90 after the transplant, and 6 and 12 months after the transplant

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Omer Koc, MD, Protocol chair(Contact information may not be current)		Ph: 216-844-8797

Registry Information
Official Title		Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients with B-Cell Non-Hodgkin's Lymphoma: in Vivo Purging with Rituximab Versus Ex-Vivo Purging with Clinamacs CD34+ Cell Enrichment Device
Trial Start Date		2000-05-18
Registered in ClinicalTrials.gov		NCT00028665
Date Submitted to PDQ		2001-11-01
Information Last Verified		2005-09-07
NCI Grant/Contract Number		CA43703

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