LymphomaPhase 1NCT00641381
Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma
A Phase 1 study testing carmustine, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- carmustine, cyclophosphamide and etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2000to 13 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV seropositive at or before the time of lymphoma diagnosis
- Subjects must be on a multi-drug regimen (excluding azidothymidine) to maintain HIV viral load less than 50,000 Gc/mL; if the CD4 count at enrollment is less than 100 then the viral load should be less than 10,000 by reverse transcriptase polymerase chain reaction (Rt-PCR); if the CD4 count is greater than 100/mm^3 prior to the start of any lymphoma chemotherapy and is greater than 100/mm^3 for at least 3 months then the viral load must be less than 150,000 gc/ml and clinically stable; if no pre-chemotherapy CD4 counts are available, then viral load alone will be used from enrollment
- The known hematopoietic toxicity of AZT (zidovudine) prohibits its use pre-transplant during stem cell collection and during the immediate period of engraftment post-transplant; resumptions of AZT should not begin until there is evidence of stable engraftment; therefore, AZT should not be resumed until at least 2 months after last blood product support is used; since platelet support continues until approximately day +14 days in our experience with acquired immune deficiency syndrome (AIDS) patients transplanted date, AZT will be prohibited until at least 2 months after transplant; therefore, if the anti-HIV drug combination needs to be modified then AZT can be part of the new regimen
- Karnofsky performance status >= 70%
- Biopsy proven intermediate grade or high-grade Non-Hodgkin's lymphoma, (working formulation groups D-H and J, and Plasmablastic lymphoma of any disease state, including first remission given the poor risk nature of this histology) or Hodgkin's lymphoma of any subtype except nodular lymphocytic and histiocytic (L\&H) lymphocyte predominant; tissue histology will be reviewed at the City of Hope
- Patients with prior marrow involvement must demonstrate < 10% involvement (by morphology) pre stem cell collection
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- Pretreatment serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) < 1.5 x institutional upper limit of normal
- Serum bilirubin < 1.5 x institutional upper limit of normal
- Patients who are Hepatitis C antibody positive or Hepatitis B surface antigen positive without clinical evidence of cirrhosis will be eligible after further evaluation; specifically, if patient hepatitis C or B positive viral loads will be measured; patients with hepatitis B and ongoing evidence of viral replication may require therapy prior to receiving high dose chemotherapy; this decision will be at the discretion of the treating physician
- Serum creatinine < 2 x institutional upper limit of normal and a 24 hour urine creatinine clearance > 60 cc/min
- Prothrombin time (PT)/partial thromboplastin time (PTT) < 2 x normal
- Forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
- Left ventricular ejection fraction (LVEF) >= 50% (by 2 dimensional [2 D] echocardiogram or multi gated acquisition scan [MUGA] scan); absence of cardiomyopathy, congestive heart failure or dysrhythmia
- If female of child bearing potential, must have negative serum pregnancy test
- Subjects must be on a prophylactic regimen for pneumocystis pneumonia if the CD4 counts are < 200
- Subjects who are not in complete remission must have measurable disease; measurable disease means that there are bidimensionally measurable lesions with clearly defined margins using either a medical photograph, computerized axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan, or palpation of lesions with both diameters >= 2 cm; evaluable disease means that the lesions are only unidimensionally measurable, or have indistinct margins or have both diameters < 0.5 cm, or that the palpable lesions have a diameter < 2.0 cm, or are lesions in bone; pleural effusions and ascites are considered nonevaluable disease; scans must be within 28 days from enrollment
- A minimum of 2.5 x 10^6 CD34 cells/kg must have been collected
- Hodgkin's Lymphoma:
- Partial response after standard chemotherapy OR
- First relapse after initial complete remission with standard chemotherapy
- Non-Hodgkin's Lymphoma:
- First complete remission after standard chemotherapy with high risk features as specified by the International Prognostic Index;
- Partial response after standard chemotherapy; OR
- Relapse after initial complete remission with standard chemotherapy
Who cannot join
- Active bacterial or fungal infection
- AIDS related opportunistic infection within past year, excluding treatment-responsive Mycobacterium Avium Intracellular infection, and treatment-responsive oral thrush, herpes simplex or herpes zoster
- Active cytomegalovirus (CMV) retinitis or other CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
- Relapse of pneumocystis carinii pneumonia within the past year
- AIDS related syndromes or symptoms that pose a perceived excessive risk for transplantation-related morbidity as determined by the principle investigator
- Intractable and severe diarrhea as defined as > 1500 cc diarrheal fluid per day of diarrhea causing persistent severed electrolyte abnormalities or hypoalbuminemia
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- History of grade III hemorrhagic cystitis due to prior chemotherapy
- Pregnant or nursing women
- Any prior malignancy except treated basal cell carcinoma of the skin; females with cervical dysplasia may be included at the discretion of the treating physician and the principle investigator
- Patients with a history of positive cerebrospinal fluid (CSF) cytology that has become negative with intrathecal chemotherapy are eligible; patients should have a negative spinal fluid cytology within thirty days prior to enrollment
- Abnormal cytogenetics on screening bone marrow biopsy
- Psychosocial conditions that hinder compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells that were collected from the patient's blood are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine, etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it works in treating patients with HIV-associated lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the feasibility and toxicity of high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide followed by autologous stem cell infusion in patients with HIV-associated lymphoma receiving combination anti-HIV therapy and to determine the efficiency of stem cell collection from these patients.
- To estimate the disease-free and overall survival of patients treated with this regimen.
- To evaluate HIV viral load, CD+4/CD+8 counts, and immune recovery after high-dose anti- lymphoma chemotherapy.
- To determine the pharmacokinetics of high-dose etoposide in patients receiving highly active anti-retroviral therapy (HAART).
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood stem cells (PBSCs) for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy.
- High-dose chemotherapy: Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.
- Autologous PBSC transplantation: Patients receive PBSC infusion on day 0. Patients undergo blood sample collection periodically for pharmacokinetic studies of etoposide.
After completion of study treatment, patients are followed at approximately 30 days and 100 days, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
- Conditions
- Lymphoma
- Being tested
- carmustine, cyclophosphamide, etoposide, pharmacological study, autologous hematopoietic stem cell transplantation
- Keywords
- stage III adult Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent mantle cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related lymphoblastic lymphoma, AIDS-related small noncleaved cell lymphoma, Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Mantle-Cell, Recurrence, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Cutaneous, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusion
cyclophosphamideDrug
100 mg/kg on day -2 prior to stem cell reinfusion
etoposideDrug
60 mg/kg on day -4 prior to stem cell reinfusion
Prior to start of etoposide infusion, 2 hours after start of infusion, just prior to the end of infusion, then at 0.5, 1, 2, 4, 24 and 48 hours after the end of infusion
autologous hematopoietic stem cell transplantationProcedure or surgery
Reinfusion of autologous stem cells
peripheral blood stem cell transplantationProcedure or surgery
Reinfusion of autologous stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment (high-dose chemotherapy, anti-HIV therapy) | Experimental | Patients undergo leukapheresis to obtain PBSCs for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy. Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients receive an autologous PBSC infusion on day 0. Receives: Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Other: pharmacological study; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope
Measured: Day 100 post stem cell reinfusion
Feasibility and treatment-associated toxicity of this regimen
Measured: 1 year post stem cell reinfusion
Secondary outcomes (3)
Ability to mobilize adequate numbers of peripheral blood stem cells (2.5 x 10e6 CD34+cells)
Measured: At the completion of stem cell collection
Disease-free and overall survival
Measured: 2 years post stem cell reinfusion
HIV viral load, CD4+/CD8+ counts, and immune recovery
Measured: 2 years post stem cell reinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study start10 May 2000
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amrita Y. Krishnan, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641381
- Sponsor's protocol ID
- 99067
- Other IDs
- P30CA033572, CHNMC-99067, CDR0000589621, NCI-2010-00431
- Status last verified
- May 2026
- First submitted
- 21 Mar 2008
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00641381
- Acronym / sponsor ID
- 99067
- Conditions
- Lymphoma
- Keywords
- stage III adult Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent mantle cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 May 2000 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells that were collected from the patient's blood are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine, etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it works in treating patients with HIV-associated lymphoma.
Detailed description
OBJECTIVES:
Primary
- To evaluate the feasibility and toxicity of high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide followed by autologous stem cell infusion in patients with HIV-associated lymphoma receiving combination anti-HIV therapy and to determine the efficiency of stem cell collection from these patients.
- To estimate the disease-free and overall survival of patients treated with this regimen.
- To evaluate HIV viral load, CD+4/CD+8 counts, and immune recovery after high-dose anti- lymphoma chemotherapy.
- To determine the pharmacokinetics of high-dose etoposide in patients receiving highly active anti-retroviral therapy (HAART).
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood stem cells (PBSCs) for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy.
- High-dose chemotherapy: Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.
- Autologous PBSC transplantation: Patients receive PBSC infusion on day 0. Patients undergo blood sample collection periodically for pharmacokinetic studies of etoposide.
After completion of study treatment, patients are followed at approximately 30 days and 100 days, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (high-dose chemotherapy, anti-HIV therapy) | Experimental | Drug: carmustine, Drug: cyclophosphamide, Drug: etoposide, Other: pharmacological study, Procedure: autologous hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationPatients undergo leukapheresis to obtain PBSCs for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy. Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients receive an autologous PBSC infusion on day 0. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- HIV seropositive at or before the time of lymphoma diagnosis
- Subjects must be on a multi-drug regimen (excluding azidothymidine) to maintain HIV viral load less than 50,000 Gc/mL; if the CD4 count at enrollment is less than 100 then the viral load should be less than 10,000 by reverse transcriptase polymerase chain reaction (Rt-PCR); if the CD4 count is greater than 100/mm^3 prior to the start of any lymphoma chemotherapy and is greater than 100/mm^3 for at least 3 months then the viral load must be less than 150,000 gc/ml and clinically stable; if no pre-chemotherapy CD4 counts are available, then viral load alone will be used from enrollment
- The known hematopoietic toxicity of AZT (zidovudine) prohibits its use pre-transplant during stem cell collection and during the immediate period of engraftment post-transplant; resumptions of AZT should not begin until there is evidence of stable engraftment; therefore, AZT should not be resumed until at least 2 months after last blood product support is used; since platelet support continues until approximately day +14 days in our experience with acquired immune deficiency syndrome (AIDS) patients transplanted date, AZT will be prohibited until at least 2 months after transplant; therefore, if the anti-HIV drug combination needs to be modified then AZT can be part of the new regimen
- Karnofsky performance status >= 70%
- Biopsy proven intermediate grade or high-grade Non-Hodgkin's lymphoma, (working formulation groups D-H and J, and Plasmablastic lymphoma of any disease state, including first remission given the poor risk nature of this histology) or Hodgkin's lymphoma of any subtype except nodular lymphocytic and histiocytic (L\&H) lymphocyte predominant; tissue histology will be reviewed at the City of Hope
Key exclusion criteria (12 listed)
- Active bacterial or fungal infection
- AIDS related opportunistic infection within past year, excluding treatment-responsive Mycobacterium Avium Intracellular infection, and treatment-responsive oral thrush, herpes simplex or herpes zoster
- Active cytomegalovirus (CMV) retinitis or other CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
- Relapse of pneumocystis carinii pneumonia within the past year
- AIDS related syndromes or symptoms that pose a perceived excessive risk for transplantation-related morbidity as determined by the principle investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carmustine150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusion | Drug | Treatment (high-dose chemotherapy, anti-HIV therapy) |
| cyclophosphamide100 mg/kg on day -2 prior to stem cell reinfusion | Drug | Treatment (high-dose chemotherapy, anti-HIV therapy) |
| etoposide60 mg/kg on day -4 prior to stem cell reinfusion | Drug | Treatment (high-dose chemotherapy, anti-HIV therapy) |
| pharmacological studyPrior to start of etoposide infusion, 2 hours after start of infusion, just prior to the end of infusion, then at 0.5, 1, 2, 4, 24 and 48 hours after the end of infusion | Other | Treatment (high-dose chemotherapy, anti-HIV therapy) |
| autologous hematopoietic stem cell transplantationReinfusion of autologous stem cells | Procedure or surgery | Treatment (high-dose chemotherapy, anti-HIV therapy) |
| peripheral blood stem cell transplantationReinfusion of autologous stem cells | Procedure or surgery | Treatment (high-dose chemotherapy, anti-HIV therapy) |
Primary outcome
Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope
Time frame: Day 100 post stem cell reinfusion
Feasibility and treatment-associated toxicity of this regimen
Time frame: 1 year post stem cell reinfusion
3 secondary outcomes
Ability to mobilize adequate numbers of peripheral blood stem cells (2.5 x 10e6 CD34+cells)
Time frame: At the completion of stem cell collection
Disease-free and overall survival
Time frame: 2 years post stem cell reinfusion
HIV viral load, CD4+/CD8+ counts, and immune recovery
Time frame: 2 years post stem cell reinfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Y. Krishnan, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carmustine, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope (time frame: Day 100 post stem cell reinfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.