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Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning


OBJECTIVES:

Primary

- Determine event-free survival of patients with aggressive non-Hodgkin's lymphoma
treated with early high-dose therapy and autologous peripheral blood stem cell (PBSC)
or bone marrow transplantation (BMT) based on positive fludeoxyglucose F 18 positron
emission tomography (FDG-PET) results obtained during first-line chemotherapy.

- Compare event-free survival of patients treated with this regimen with historical
event-free survival of patients with positive FDG-PET results obtained during
first-line chemotherapy that are not treated with early high-dose therapy.

Secondary

- Compare overall survival of patients treated with a standard treatment regimen vs early
high-dose therapy and autologous PBSC or BMT based on FDG-PET results obtained during
first-line chemotherapy.

- Determine the predictive value of an early negative FDG-PET result in these patients.

- Correlate International Prognostic Index risk category with FDG-PET results and overall
outcome in these patients.

OUTLINE: This is a pilot study.

- First-line chemotherapy: Patients receive cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, oral prednisone on days 1-5, and rituximab IV on day 1
(patients with CD20-positive disease only) OR another standard first-line chemotherapy
regimen. Treatment repeats every 14-21 days for 2 or 3 courses in the absence of
disease progression or unacceptable toxicity.

- Radiographic staging: Between days 11-20 of course 2 or 3 OR days 11-13 of course 3 of
first-line chemotherapy, patients receive fludeoxyglucose F 18 (FDG) IV. One hour
later, patients undergo whole-body FDG-positron emission tomography (PET) and CT scan.
Patients with no evidence of malignant disease by FDG-PET (i.e., negative result)
receive a standard treatment regimen that may include localized radiotherapy for
limited stage or bulky disease followed, 4-6 weeks later, by a repeat whole-body
FDG-PET and CT scan. Patients with progressive disease after first-line chemotherapy
are removed from the study. Patients with evidence of malignant disease by FDG-PET
(i.e., positive result) and stable disease or better proceed to ESHAP chemotherapy.

- ESHAP chemotherapy: Patients receive etoposide IV over 2 hours, methylprednisolone IV,
and cisplatin IV over 3 hours on days 1-4 followed by cytarabine IV over 2 hours on day
5. Patients with CD20-positive disease also receive rituximab IV on day 1. Treatment
repeats every 14-21 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Beginning 1 day after completion of course 2, patients receive
filgrastim (G-CSF) subcutaneously once daily followed by leukapheresis to collect
peripheral blood stem cells (PBSC). Some patients may also undergo bone marrow (BM)
harvest if sufficient PBSC are not collected. Patients with a sufficient number of stem
cells proceed to high-dose therapy and autologous PBSC transplantation (PBSCT) or BM
transplantation (BMT).

- High-dose therapy and PBSCT or BMT: No more than 4 weeks after completion of PBSC
collection or BM harvest, patients receive high-dose therapy that may include
cyclophosphamide and total-body irradiation OR busulfan and cyclophosphamide. Patients
then undergo PBSCT or BMT. Between 4-6 weeks after completion of PBSCT or BMT, patients
undergo repeat whole-body FDG-PET and CT scan. Patients may also undergo consolidative
radiotherapy to the sites of bulky disease at the discretion of the physician.

After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2
years, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following
subtypes:

- Diffuse large B-cell lymphoma

- Mediastinal (thymic) B-cell lymphoma

- Grade 3 follicular lymphoma

- Anaplastic large cell lymphoma

- Peripheral T-cell lymphoma

- Must have adequate staging of disease by the following techniques:

- CT scan or MRI of affected sites

- Bone marrow biopsy (in cases where results influence the duration of
chemotherapy only)

- Lumbar puncture (if clinically indicated)

- Stage I-IV disease

- Any International Prognostic Index risk category

- Radiographically measurable disease

- None of the following aggressive non-Hodgkin's subtypes are allowed:

- Mantle cell lymphoma

- Lymphoblastic lymphoma

- Burkitt's lymphoma

- Mycosis fungoides/Sezary's syndrome

- HTLV-1-associated T-cell leukemia/lymphoma

- Primary CNS lymphoma

- HIV-associated lymphoma

- Transformed lymphomas

- No prior diagnosis of another hematologic malignancy

- No known progressive disease during prior first-line chemotherapy

- No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is
previously treated and in remission

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-4 (0-2 for peripheral blood stem cell [PBSC] or bone marrow transplantation
[BMT] patients)

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3*

- Platelet count ≥ 75,000/mm^3 NOTE: *PBSC or BMT patients only

Hepatic

- Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma*

- No known significant hepatic dysfunction that is not expected to improve and would
preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Renal

- Creatinine ≤ 2.0 mg/dL*

- No known significant renal dysfunction that is not expected to improve and would
preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Cardiovascular

- Ejection fraction ≥ 45% by echocardiogram or MUGA*

- No known significant cardiac dysfunction that is not expected to improve and would
preclude PBSC or BMT NOTE: *PBSC or BMT patients only; a cardiology consult and
evaluation may override ejection fraction criterion

Pulmonary

- FEV_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or
mantle radiotherapy (75% of predicted for patients who have received thoracic or
mantle radiotherapy)*

- No known significant pulmonary dysfunction that is not expected to improve and would
preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 3 years except carcinoma in situ of the cervix or
nonmelanoma skin cancer

- No known HIV positivity OR HIV negative (for PBSC or BMT patients only)

- No serious illness that would preclude study participation

- No contraindication to autologous BMT

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No more than 3 prior courses of chemotherapy for lymphoma

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

2-year event free survival

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000445618

NCT ID:

NCT00238368

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • anaplastic large cell lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410