NCT00641381

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started May 2000

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2000

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

25.8 years

First QC Date

March 21, 2008

Last Update Submit

May 1, 2026

Conditions

Lymphoma

Keywords

stage III adult Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent childhood lymphoblastic lymphomarecurrent mantle cell lymphomarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related lymphoblastic lymphomaAIDS-related small noncleaved cell lymphomaBurkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage IV childhood lymphoblastic lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (2)

  • Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope

    Day 100 post stem cell reinfusion

  • Feasibility and treatment-associated toxicity of this regimen

    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)

    At the completion of stem cell collection

  • Disease-free and overall survival

    2 years post stem cell reinfusion

  • HIV viral load, CD4+/CD8+ counts, and immune recovery

    2 years post stem cell reinfusion

Study Arms (1)

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.

Drug: carmustineDrug: cyclophosphamideDrug: etoposideOther: pharmacological studyProcedure: autologous hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation

Interventions

carmustineDRUG

150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusion

Treatment (high-dose chemotherapy, anti-HIV therapy)
cyclophosphamideDRUG

100 mg/kg on day -2 prior to stem cell reinfusion

Treatment (high-dose chemotherapy, anti-HIV therapy)
etoposideDRUG

60 mg/kg on day -4 prior to stem cell reinfusion

Treatment (high-dose chemotherapy, anti-HIV therapy)
pharmacological studyOTHER

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

Treatment (high-dose chemotherapy, anti-HIV therapy)
autologous hematopoietic stem cell transplantationPROCEDURE

Reinfusion of autologous stem cells

Treatment (high-dose chemotherapy, anti-HIV therapy)
peripheral blood stem cell transplantationPROCEDURE

Reinfusion of autologous stem cells

Treatment (high-dose chemotherapy, anti-HIV therapy)

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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
  • +9 more criteria

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Mantle-CellRecurrencePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CarmustineCyclophosphamideEtoposidePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Amrita Y. Krishnan, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 24, 2008

Study Start

May 10, 2000

Primary Completion

February 13, 2026

Study Completion

February 13, 2026

Last Updated

May 4, 2026

Record last verified: 2026-05

Locations

US(1)