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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
etoposide
BCNU
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Cancer Specialists
  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Autologous Transplant

Allogeneic Transplant

Arm Description

autologous hematopoietic progenitor cell transplant

allogeneic hematopoietic progenitor cell trasnplant

Outcomes

Primary Outcome Measures

relapse rate
determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 3, 2013
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005613
Brief Title
Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Acronym
CBV
Official Title
A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Transplant
Arm Type
Experimental
Arm Description
autologous hematopoietic progenitor cell transplant
Arm Title
Allogeneic Transplant
Arm Type
Experimental
Arm Description
allogeneic hematopoietic progenitor cell trasnplant
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
vp-16
Intervention Description
Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
Intervention Type
Drug
Intervention Name(s)
BCNU
Other Intervention Name(s)
Carmustine
Intervention Description
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
Primary Outcome Measure Information:
Title
relapse rate
Description
determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C. Goldstein, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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