Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Launched by TEMPLE UNIVERSITY · Jan 26, 2003
Trial Information
Current as of March 19, 2025
Completed
Keywords
ClinConnect Summary
OBJECTIVES:
* Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell rescue in patients with relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma.
* Determine the overall response rate and survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the differences in the rates of engraftment, response, and survival of patients treated with bone marrow vs peripheral blo...
Gender
ALL
Eligibility criteria
- DISEASE CHARACTERISTICS:
- • Histologically proven relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma
- * Eligible subtypes:
- • Diffuse small cleaved cell
- • Diffuse mixed (small and large cell)
- • Diffuse large cell
- • Large cell immunoblastic
- • Lymphoblastic
- • Small noncleaved cell
- • High-grade histology patients should first be considered for Protocol TUHSC-1520
- * Must have chemosensitive disease, defined by 1 of the following conditions:
- • Response to initial chemotherapy without obtaining complete response (CR)(refractory lymphoma)
- • Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25% for more than 1 month after completion of 1-3 courses of salvage chemotherapy (chemosensitive relapse)
- * No chemoresistant disease, defined by the following conditions:
- • Unresponsive or progressive disease during initial chemotherapy
- • Relapse after chemotherapy-induced CR if tumor volume not reduced by at least 25% after completion of 1-3 courses salvage chemotherapy (chemoresistant relapse)
- • No CNS involvement by lymphoma
- • Syngeneic bone marrow transplantation offered to patients with consenting identical twin donor NOTE: 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:
- • 15 to 60 (physically fit patients up to age 70 may be considered)
- Performance status:
- • ECOG 0-2
- Life expectancy:
- • Not specified
- Hematopoietic:
- • Not specified
- Hepatic:
- • Bilirubin no greater than 2.0 mg/dL
- • AST and ALT not persistently greater than 2 times normal
- Renal:
- • Creatinine less than 1.8 mg/dL
- Cardiovascular:
- • Cardiac ejection fraction at least 45%
- Pulmonary:
- • DLCO, FEV_1, and FVC at least 50% predicted
- • Resting pO_2 at least 70 mm Hg
- Other:
- • HIV negative
- • No other concurrent disease that would limit life expectancy
- • No active infection
- • No severe neurologic or emotional disorders
- • Not pregnant
- • Fertile patients must use effective contraception
- • Adequate psychological support available
- PRIOR CONCURRENT THERAPY:
- • Biologic therapy
- • Not specified
- • Chemotherapy
- • See Disease Characteristics
- • Endocrine therapy
- • Not specified
- • Radiotherapy
- • Not specified
- • Surgery
- • Not specified
Trial Officials
Kenneth F. Mangan, MD, FACP
Study Chair
Fox Chase Cancer Center
About Temple University
Temple University is a leading academic institution located in Philadelphia, Pennsylvania, renowned for its commitment to research and innovation in the health sciences. As a clinical trial sponsor, Temple University leverages its extensive resources, including a diverse pool of participants and cutting-edge facilities, to advance medical knowledge and improve patient care. The university's clinical research initiatives are driven by a multidisciplinary team of experts dedicated to conducting high-quality studies that address critical health issues and contribute to the development of novel therapies. Through its partnerships with local and global organizations, Temple University aims to enhance the translation of research findings into practical applications that benefit communities and advance public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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