Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Lymphoma Clinical Trial

— CBV  

Official title:

A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005613
• Other study ID #: 11306
• Secondary ID: MCC-11306IRB-425
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: June 3, 2013
• Start date: March 1996
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.

Description:

OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2010
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that has relapsed or failed to achieve complete remission after first line induction chemotherapy Intermediate or high grade (including mantle cell, but excluding lymphoblastic disease) No more than 1 prior salvage chemotherapy regimen, e.g.: Dexamethasone, high dose cytarabine, and cisplatin (DHAP) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP) Low grade No more than 2 prior salvage chemotherapy regimens, e.g.: Fludarabine, mitoxantrone, and dexamethasone (FND) ESHAP DHAP OR Histologically proven stage III or IV Hodgkin's disease that has relapsed or failed to achieve remission after combination induction chemotherapy Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, liver/marrow involvement) No more than 2 prior salvage chemotherapy regimens Allogeneic stem cell transplantation group: Availability of 6 antigen (A, B, and DR loci) HLA matched sibling donor No active CNS disease 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 55 Performance status: ECOG 0 or 1 Life expectancy:

Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 times normal PT and PTT normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 45% by MUGA scan or echocardiogram No myocardial infarction within the past 6 months No arrhythmias unless medically controlled Pulmonary: FEV1 at least 50% predicted DLCO at least 50% predicted Other: No diabetes mellitus or thyroid disease unless medically controlled No active serious infection HIV negative Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• cyclophosphamide
Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
• etoposide
Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
• BCNU
BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4

Locations

Country	Name	City	State
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate	determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation	5 years	Yes