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High-Dose chemo and stem cell transplant shows promise for HIV lymphoma patients

NCT ID NCT00641381

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested whether high-dose chemotherapy followed by a stem cell transplant is safe and feasible for 25 people with HIV who also have lymphoma. The goal was to see how well the body recovers and to monitor side effects. Results could point to a new treatment path for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-dose chemotherapy (carmustine, etoposide, cyclophosphamide) followed by autologous stem cell transplant
What this could lead to
If successful, this approach could offer a treatment option for people with HIV who develop lymphoma, potentially improving survival.
What could go wrong
This is a small, early-phase trial focused on safety, so it's too soon to know if it works. High-dose chemotherapy has serious side effects, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2000

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010-3000, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.