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LymphomaPhase 2NCT00028665

Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma

A Phase 2 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and carmustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Jun 2000to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106-7284

Other trials in United States

About this study

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

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation.

PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkin's lymphoma.

Read the detailed description

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.

Conditions
Lymphoma
Being tested
filgrastim, rituximab, carmustine, cisplatin, cyclophosphamide
Keywords
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
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.

  • rituximabBiological

    rituximab IV over 2-5 hours on days 1, 8, and 15

  • carmustineDrug

    After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3

  • cisplatinDrug

    After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.

  • cyclophosphamideDrug

    cyclophosphamide IV over 3-6 hours on day 16.

  • etoposideDrug

    After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.

  • bone marrow ablation with stem cell supportProcedure or surgery

    Patients then undergo peripheral blood stem cell (PBSC) collection.

  • peripheral blood stem cell transplantationProcedure or surgery

    Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.

  • radiation therapyRadiation

    Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

Study groups in NCT00028665
Study groupRoleWhat they receive
Arm I: with rituximab IVExperimentalNot described
Receives: Biological: filgrastim; Biological: rituximab; Drug: carmustine; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy
Arm II: without rituximab IVActive comparatorNot described
Receives: Biological: filgrastim; Drug: carmustine; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total CD34 cells

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

  2. T and B lymphocyte counts

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

  3. Disease response

    Measured: measured at 4 weeks after the transplant

  4. Engraftment

    Measured: measured at days 42 and 90 after the transplant, and 6 and 12 months after the transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2000
  3. Primary completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028665
Sponsor's protocol ID
CWRU1499
Other IDs
P30CA043703, CWRU1499, CWRU-030040, NCI-G01-2040
Status last verified
Jun 2010
First submitted
4 Jan 2002
Last updated
10 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total CD34 cells (time frame: measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2010.

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