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A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma

Phase 2
1 Year
21 Years
Open (Enrolling)

Thank you

Trial Information

A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma


- Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and
non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood
stem cell transplantation (PBSCT) in patients who achieve a complete remission or
partial remission.

- Estimate the post complete/partial remission failure-free survival rate in these

- Characterize the time to recovery of normal bone marrow function after transplantation
in these patients.

OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow
biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow
involvement is still present at harvest, then 2 additional courses of induction chemotherapy
are given.

The PBSC transplantation preparative regimen should begin within 2 weeks of completing
reinduction therapy course, consisting of the following:

- Carmustine IV over 3 hours on days -8, -7, and -6

- Etoposide continuous IV over days -8, -7, and -6

- Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2

- Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12
hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to
protect lungs from the toxic effects of carmustine.

PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.

Inclusion Criteria


- Histologically confirmed non-Hodgkin's lymphoma in first relapse or refractory after
primary induction therapy

- Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with
more than one nodal region involved at relapse or refractory after primary induction
therapy (i.e., failed to achieve remission at the conclusion of standard induction

- No prior radiotherapy only for low stage nodal disease

- No greater than 4 courses of standard chemotherapy for low stage nodal disease

- CSF or bone marrow involvement at time of study entry is allowed



- 1 to 21 (at initial diagnosis)

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- SGOT or SGPT less than 2.5 times normal

- Bilirubin no greater than 1.5 mg/dL


- Creatinine less than 1.5 mg/dL

- Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or
24 hour urine collection for creatinine clearance


- Shortening fraction of at least 28% by echocardiogram

- Ejection fraction of at least 40% by radionuclide angiogram echocardiogram


- Total lung capacity (TLC) at least 50% OR

- Vital capacity (VC) at least 65% of normal

- DLCO at least 55% of normal

- For children who are uncooperative to pulmonary function testing, no dyspnea at rest
or with mild exercise, and a pulse oximetry of at least 95%


- HIV negative


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- See Disease Characteristics


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard E. Harris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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