Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00345865
• Collaborator: (none)
• Enrollment: 473
• Location: 1
• Arms: 5
• Actual Duration (Months): 166.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: peripheral blood stem cell transplantation; Radiation: irradiation therapy; Biological: G-CSF; Drug: Cytarabine	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the disease-free survival and overall survival of patients with non-Hodgkin's or Hodgkin's lymphoma treated with autologous peripheral blood stem cell transplantation (PBSCT).

• Verify the safety and efficacy of autologous PBSCT in patients with HIV disease and relapsed lymphoma.

Secondary

• Evaluate immune reconstitution in HIV-positive patients undergoing autologous PBSCT and compare to immune reconstitution in HIV-negative patients.

• Predict the adequacy of peripheral blood stem cell (PBSC) harvest prior to flow analysis of a PBSC yield.

• Determine the time to engraftment for neutrophils and platelets.

OUTLINE:

• Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF) alone: Patients not requiring further disease reduction receive G-CSF subcutaneously (SC) once daily on days 1-8. Patients undergo PBSC collection by leukapheresis on days 5-8. Patients who do not adequately mobilize with G-CSF alone proceed to chemo-mobilization.

• Chemo-mobilization: Patients requiring further disease reduction receive 1 of 2 chemo-mobilization regimens.

• Patients with CD20+ non-Hodgkin's lymphoma (NHL) or lymphocyte predominant Hodgkin's lymphoma: Patients receive rituximab intravenously (IV) over 6-8 hours on day 1, ifosfamide IV over 2 hours and etoposide IV over 30 minutes on days 2-4, and carboplatin IV over 1 hour on day 2. Patients receive G-CSF SC once daily beginning on day 5 and continuing until leukapheresis is completed. Patients undergo PBSC collection by leukapheresis on days 12-15.

• All other patients: Patients receive ifosfamide IV over 2 hours and etoposide IV over 30 minutes on days 1-3 and carboplatin IV over 1 hour on day 1. Patients receive G-CSF SC once daily beginning on day 4 and continuing until leukapheresis is completed. Patients undergo PBSC collection by leukapheresis on days 12-15.

• Autologous PBSC transplantation (PBSCT) (Patients with NHL undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.

• Autologous PBSCT (Patients with Hodgkin's lymphoma or NHL not undergoing irradiation and cyclophosphamide): Patients receive camustine IV over 2 hours on days -6, etoposide IV over 2 hours twice daily on days -5 to -2, and melphalan over 1 hour on day -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.

• Autologous PBSC transplantation (PBSCT) (Patients with HL not undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -6 to -3, camustine IV over 2 hours on day -6, and etoposide IV over 4 hours twice daily on days -6 to -4. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.

• Post-transplant irradiation: Patients undergo post-transplant irradiation beginning on day 28. Persisting nodal masses ≥ 2 cm are treated with additional localized external beam irradiation.

• Post-transplant Rituximab therapy: patients with CD20+ NHL may undergo Rituximab maintenance starting between day +45 and +90 and being repeated at day +180 ± 14 days.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 473 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
• Actual Study Start Date: Aug 24, 2005
• Actual Primary Completion Date: Jun 28, 2019
• Actual Study Completion Date: Jun 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NHL with irradiation Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Drug: cyclophosphamide; NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.; Other Names: Cytoxan ; Procedure: peripheral blood stem cell transplantation; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Other Names: PBSC ; Radiation: irradiation therapy; Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. > 1000 cGy to whole lung, kidney, or abdominal bath. > 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes. > 3600 cGy to whole brain.; Biological: G-CSF; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF.; Other Names: filgrastim
Experimental: HL without irradiation Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Drug: carmustine; Day -6, 300 mg/m^2 over 2 hour; Other Names: BNCU ; Drug: cyclophosphamide; NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.; Other Names: Cytoxan ; Drug: etoposide; NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.; Other Names: VP-16 ; Procedure: peripheral blood stem cell transplantation; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Other Names: PBSC ; Biological: G-CSF; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF.; Other Names: filgrastim
Experimental: NHL - HIV infected with irradiation Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Drug: cyclophosphamide; NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.; Other Names: Cytoxan ; Procedure: peripheral blood stem cell transplantation; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Other Names: PBSC ; Radiation: irradiation therapy; Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. > 1000 cGy to whole lung, kidney, or abdominal bath. > 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes. > 3600 cGy to whole brain.; Biological: G-CSF; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF.; Other Names: filgrastim
Experimental: NHL - HIV infected without irradiation Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Drug: carmustine; Day -6, 300 mg/m^2 over 2 hour; Other Names: BNCU ; Drug: cyclophosphamide; NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.; Other Names: Cytoxan ; Drug: etoposide; NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.; Other Names: VP-16 ; Procedure: peripheral blood stem cell transplantation; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Other Names: PBSC ; Biological: G-CSF; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF.; Other Names: filgrastim
Experimental: NHL without radiation and cyclosporine Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).	Drug: carmustine; Day -6, 300 mg/m^2 over 2 hour; Other Names: BNCU ; Drug: etoposide; NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.; Other Names: VP-16 ; Procedure: peripheral blood stem cell transplantation; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Other Names: PBSC ; Biological: G-CSF; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF.; Other Names: filgrastim ; Drug: Cytarabine; 100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.; Other Names: Ara-C cytosine arabinoside Cytosar-U Depocyt

Outcome Measures

Primary Outcome Measures

1. Number of Participants With 1 Year Progression Free Survival [1 year]

   Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

2. Number of Participants With 2 Years Progression Free Survival [2 years]

   Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

3. Number of Participants With 1 Year Overall Survival [1 year]

4. Number of Participants With 2 Years Overall Survival [2 years]

Secondary Outcome Measures

1. Number of Participants With Hematopoietic Recovery After Transplantation [Day 42]

   return to ANC (absolute neutrophil count) more than 500 cells/milliliter.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Karnofsky performance status: >80% (>60% if poor performance status is related to lymphoma)

• No evidence of serious organ dysfunction that is not attributable to tumor

• Central nervous system: Patients with a history of CNS involvement by lymphoma or with relapsed primary lymphoma will be eligible.

• Infection: Patients with serious uncontrolled infections at the time of transplant will be excluded.

• Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study. These patients are not eligible to receive rituximab as a component of their chemotherapy mobilization.

• HIV disease. Patients with HIV disease are eligible for this study provided that:

• Patients will be seen in the infectious disease (ID)/HIV clinic prior to enrollment on study for the purpose of determining eligibility and for local coordination of HIV care during the peri-transplant period.

• Must be on a maximally active anti-HIV regimen

• CD4+ ≥ 50/μL

• HIV RNA viral load ≤ 100,000 copies per mL on each of samples 4 weeks apart. The most recent level must be within one month of enrollment.

• Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed NHL.

• Precursor B-cell or Precursor T-cell NHL

• Lymphoblastic lymphoma

• All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR)

• Mature B-cell Lymphomas:

• Small lymphocytic lymphoma (SLL) or Chronic Lymphocytic Leukemia (CLL)

• Follicular Lymphoma

• Diffuse Large B-cell Lymphoma

• Mantle Cell Lymphoma

• Burkitt's/Burkitt's like

• Mature T-cell lymphoma

• Hodgkin's lymphoma (HL)

• patients with histologically proven HL will be eligible for transplantation after failing prior therapy.

Exclusion Criteria:

• Patients eligible for any higher priority transplant protocols

• Women who are pregnant or breast feeding

• Patients with chemotherapy resistant disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota

Investigators

• Principal Investigator: Veronika Bachanova, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2014

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00345865
• Other Study ID Numbers: 2005LS048; UMN-0508M72589; UMN-MT2004-24
• First Posted: Jun 29, 2006
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Masonic Cancer Center, University of Minnesota: Hodgkin lymphoma; non-Hodgkin lymphoma; HIV-associated lymphoma
• Additional relevant MeSH terms: Lymphoma; Cytarabine; Cyclophosphamide; Carmustine; Etoposide

Study Results

Participant Flow

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Period Title: Overall Study
STARTED	171	149	2	5	146
COMPLETED	171	149	2	5	146
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide	Total
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).	Total of all reporting groups
Overall Participants	171	149	2	5	146	473
Age (Count of Participants)
<=18 years	4 2.3%	13 8.7%	0 0%	0 0%	0 0%	17 3.6%
Between 18 and 65 years	126 73.7%	129 86.6%	2 100%	4 80%	107 73.3%	368 77.8%
>=65 years	41 24%	7 4.7%	0 0%	1 20%	39 26.7%	88 18.6%
Sex: Female, Male (Count of Participants)
Female	53 31%	74 49.7%	1 50%	1 20%	54 37%	183 38.7%
Male	118 69%	75 50.3%	1 50%	4 80%	92 63%	290 61.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	1 0.7%	1 0.2%
Asian	4 2.3%	2 1.3%	0 0%	0 0%	3 2.1%	9 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	10 5.8%	5 3.4%	1 50%	0 0%	4 2.7%	20 4.2%
White	147 86%	127 85.2%	1 50%	5 100%	135 92.5%	415 87.7%
More than one race	1 0.6%	3 2%	0 0%	0 0%	0 0%	4 0.8%
Unknown or Not Reported	9 5.3%	12 8.1%	0 0%	0 0%	3 2.1%	24 5.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With 1 Year Progression Free Survival
Description	Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Measure Participants	171	149	2	5	146
Count of Participants [Participants]	112 65.5%	102 68.5%	1 50%	2 40%	116 79.5%

2. Primary Outcome

Title	Number of Participants With 2 Years Progression Free Survival
Description	Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Measure Participants	171	149	2	5	146
Count of Participants [Participants]	96 56.1%	91 61.1%	1 50%	1 20%	106 72.6%

3. Primary Outcome

Title	Number of Participants With 1 Year Overall Survival
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Measure Participants	171	149	2	5	146
Count of Participants [Participants]	139 81.3%	144 96.6%	1 50%	5 100%	128 87.7%

4. Primary Outcome

Title	Number of Participants With 2 Years Overall Survival
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Measure Participants	171	149	2	5	146
Count of Participants [Participants]	124 72.5%	140 94%	1 50%	4 80%	121 82.9%

5. Secondary Outcome

Title	Number of Participants With Hematopoietic Recovery After Transplantation
Description	return to ANC (absolute neutrophil count) more than 500 cells/milliliter.
Time Frame	Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Irradiation	NHL - HIV Infected Without Irradiation	NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.	Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.	Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Measure Participants	171	149	2	5	145
Count of Participants [Participants]	171 100%	147 98.7%	2 100%	5 100%	145 99.3%

Adverse Events

Time Frame	2 years
Arm/Group Title	NHL With Irradiation		HL Without Irradiation		NHL - HIV Infected With Irradiation		NHL - HIV Infected Without Irradiation		NHL Without Radiation and Cyclophosphamide
Arm/Group Description	Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.		Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.		Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.		Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.		Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
All Cause Mortality
	NHL With Irradiation		HL Without Irradiation		NHL - HIV Infected With Irradiation		NHL - HIV Infected Without Irradiation		NHL Without Radiation and Cyclophosphamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/171 (27.5%)		9/149 (6%)		1/2 (50%)		1/5 (20%)		25/146 (17.1%)
Serious Adverse Events
	NHL With Irradiation		HL Without Irradiation		NHL - HIV Infected With Irradiation		NHL - HIV Infected Without Irradiation		NHL Without Radiation and Cyclophosphamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/171 (19.9%)		18/149 (12.1%)		1/2 (50%)		1/5 (20%)		0/146 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death	4/171 (2.3%)	4	0/149 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Disease progression	9/171 (5.3%)	12	4/149 (2.7%)	4	1/2 (50%)	1	0/5 (0%)	0	0/146 (0%)	0
Relapse	12/171 (7%)	12	12/149 (8.1%)	12	0/2 (0%)	0	1/5 (20%)	1	0/146 (0%)	0
Myelodysplasia	1/171 (0.6%)	1	0/149 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Death due to progression	4/171 (2.3%)	4	1/149 (0.7%)	1	1/2 (50%)	1	0/5 (0%)	0	0/146 (0%)	0
Death due to relapse	8/171 (4.7%)	8	1/149 (0.7%)	1	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Death due to multi organ failure	1/171 (0.6%)	1	1/149 (0.7%)	1	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hemorrhage	1/171 (0.6%)	1	0/149 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Pulmonary failure	1/171 (0.6%)	1	0/149 (0%)	0	0/2 (0%)	0	0/5 (0%)	0	0/146 (0%)	0
Other (Not Including Serious) Adverse Events
	NHL With Irradiation		HL Without Irradiation		NHL - HIV Infected With Irradiation		NHL - HIV Infected Without Irradiation		NHL Without Radiation and Cyclophosphamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	125/171 (73.1%)		98/149 (65.8%)		2/2 (100%)		2/5 (40%)		120/146 (82.2%)
Cardiac disorders
Decreased heart function	20/171 (11.7%)	26	16/149 (10.7%)	21	0/2 (0%)	0	2/5 (40%)	3	20/146 (13.7%)	31
Endocrine disorders
hypothyroidism	9/171 (5.3%)	10	10/149 (6.7%)	11	0/2 (0%)	0	0/5 (0%)	0	1/146 (0.7%)	1
Gastrointestinal disorders
GI bleeding	12/171 (7%)	13	3/149 (2%)	4	1/2 (50%)	1	1/5 (20%)	2	5/146 (3.4%)	6
Infections and infestations
Infection	94/171 (55%)	331	63/149 (42.3%)	187	1/2 (50%)	1	2/5 (40%)	15	103/146 (70.5%)	291
Injury, poisoning and procedural complications
Surgery	5/171 (2.9%)	8	3/149 (2%)	3	0/2 (0%)	0	1/5 (20%)	1	5/146 (3.4%)	6
Metabolism and nutrition disorders
deconditioning	7/171 (4.1%)	11	2/149 (1.3%)	2	0/2 (0%)	0	0/5 (0%)	0	7/146 (4.8%)	9
Nervous system disorders
Neuropathy	29/171 (17%)	39	12/149 (8.1%)	13	0/2 (0%)	0	0/5 (0%)	0	14/146 (9.6%)	16
sensory loss	20/171 (11.7%)	26	4/149 (2.7%)	4	0/2 (0%)	0	0/5 (0%)	0	8/146 (5.5%)	8
Renal and urinary disorders
Other Kidney disorder	23/171 (13.5%)	36	6/149 (4%)	10	1/2 (50%)	2	2/5 (40%)	2	9/146 (6.2%)	10
Respiratory, thoracic and mediastinal disorders
Pneumonia	67/171 (39.2%)	160	53/149 (35.6%)	102	1/2 (50%)	1	2/5 (40%)	6	55/146 (37.7%)	102
Intubation	9/171 (5.3%)	17	6/149 (4%)	8	0/2 (0%)	0	0/5 (0%)	0	6/146 (4.1%)	7
Vascular disorders
Deep vein thrombosis	9/171 (5.3%)	10	8/149 (5.4%)	9	1/2 (50%)	1	0/5 (0%)	0	15/146 (10.3%)	16
Thrombosis	10/171 (5.8%)	10	8/149 (5.4%)	9	1/2 (50%)	1	0/5 (0%)	0	8/146 (5.5%)	10

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.