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Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemotherapy


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemotherapy


OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor
prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma
who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab
(IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and
consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/
etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a
historical control population. II. Evaluate the ability of posttransplant rituximab therapy
in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma
remaining after high dose therapy in these patients. III. Evaluate quality of life
parameters and assess the risk of secondary malignancies following this treatment regimen in
these patients.

OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again
approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients
receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood
stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously
beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days.
At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody;
anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at
week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week
continuing through rituximab therapy. At approximately 3 and 9 months posttransplant,
patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide,
etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV
over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients
receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3.
Patients are followed at least every 6 weeks to 3 months until death.

PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade B-cell
non-Hodgkin's lymphoma that meets one of the following criteria: - Relapsed or progressed
following at least 1 course of standard therapy - Developed from a low grade lymphoma
regardless of remission status - In first complete response with 3 or more of the
following pretreatment criteria met at the time of original diagnosis: Stage III/IV
disease Two or more extranodal sites of disease Lactate dehydrogenase greater than 1.2
times normal Performance status 2-4 (at time of diagnosis) Dimension of the largest tumor
at least 10 cm No myelodysplasia 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 75 Performance status: See Disease Characteristics
ECOG 0-2 (ECOG 3-4 acceptable if based solely on pain) Life expectancy: Not specified
Hematopoietic: CD34 cells at least 1,000/g Hepatic: See Disease Characteristics Bilirubin
no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No
active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL
Cardiovascular: No evidence for clinically significant functional impairment Left
ventricular ejection fraction at least 45% Patients with lower ejection fractions may be
included if a formal cardiological evaluation reveals no evidence for clinically
significant functional impairment Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted
If unable to complete pulmonary function tests due to bone pain or fracture, must have a
high resolution CT scan of the chest and acceptable blood arterial gases defined as PO2
greater than 70 Other: HIV negative No active infection that is unresponsive to
intravenous antibiotics Not pregnant or nursing Effective contraception required of all
fertile patients

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Aaron P. Rapoport, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066399

NCT ID:

NCT00003397

Start Date:

September 1998

Completion Date:

December 2002

Related Keywords:

  • Lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt 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 III adult Burkitt 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
  • stage IV adult Burkitt 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
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201