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Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

Phase 2
15 Years
70 Years
Open (Enrolling)

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Trial Information

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II


- Determine the 2-year progression-free survival of patients with progressive or
recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation
(2 courses of high-dose therapy with autologous stem cell rescue).

- Determine the response rate in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Salvage therapy (for patients with relapsed disease after achieving a previous complete
response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell

- Autologous hematopoietic stem cell collection: Patients undergo autologous
hematopoietic stem cell collection. Patients with an inadequate number of collected
stem cells are removed from the study.

- Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after
initial salvage therapy undergo involved-field radiotherapy. All patients then proceed
to the first preparative regimen.

- First preparative regimen: Patients receive high-dose melphalan IV on day -1.

- First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on
day 0. At least 28 days later, patients proceed to second preparative regimen.

- Second preparative regimen: Patients receive 1 of the following preparative regimens:

- Total-body irradiation (TBI)-based regimen: Patients undergo TBI twice daily on
days -8 to -5. Patients also receive etoposide IV over 4 hours on day -4 and
cyclophosphamide IV over 1 hour on day -2.

- Carmustine-based regimen: Patients receive carmustine IV over 2 hours on days -6
to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on
day -2.

- Second autologous SCT: Patients undergo second autologous SCT on day 0. After
completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 7 years.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed Hodgkin's lymphoma

- Relapsed or refractory disease

- Biopsy or radiological evidence of disease at time of recurrence/progression

- Has received ≥ 1 prior systemic chemotherapy regimen

- No clonal abnormalities in marrow collection

- Must undergo involved-field radiotherapy if bulky disease > 5 cm

- Must have adequate sections of original diagnostic specimen available for review

- Needle aspirations or cytologies are not adequate

- No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free > 5

- Patients who relapse after achieving a complete remission must complete a minimum of
2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or
resistant recurrent disease is present

- No central nervous system (CNS) involvement



- 15 to 70

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease)


- Creatinine clearance ≥ 60 mL/min

- Creatinine ≤ 2 times upper limit of normal


- None of the following conditions requiring therapy:

- Coronary artery disease

- Cardiomyopathy

- Congestive heart failure

- Arrhythmias

- Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram


- Adequate pulmonary function

- Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR

- Forced Expiratory Volume in One Side (FEV_1) ≥ 60% of predicted


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer

- No known HIV or AIDS infection

- No active bacterial, fungal, or viral infection

- No medical condition that would preclude study treatment


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- See Disease Characteristics


- Not specified

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year Progression-free Survival

Outcome Description:

Measured from date of randomization to date of first observation of progressive disease, or death due to any cause

Outcome Time Frame:

At day 60, then every 6 months for 2 years

Safety Issue:


Principal Investigator

Eileen P. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

February 2016

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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