Autologous Stem Cell Transplant for Lymphoma
This study is looking at an autologous (using your own cells) stem cell transplant for people with Hodgkin Lymphoma (HL) or Non-Hodgkin Lymphoma (NHL), including those who are HIV positive. Researchers are testing different combinations of chemotherapy drugs like Etoposide, BCNU, AraC, and Melphalan, followed by a peripheral blood stem cell transplant. The main goal is to see how long patients live without their cancer progressing (Progression Free Survival) three years after the transplant. You may be able to join if you are up to 75 years old and have chemo-sensitive NHL or HL. The study plans to enroll 150 participants, but its current status is unclear.
- Study design
- This is a Phase II interventional study, meaning it's testing a treatment in a larger group of people to see if it's effective and safe. It plans to enroll 150 participants.
- What's involved
- You would receive chemotherapy drugs (Etoposide, BCNU, AraC, Melphalan) over several days, followed by a peripheral blood stem cell transplant on Day 0. Your stem cells would be collected beforehand through a process called leukapheresis.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured at 3 years after the transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03125642
Auto Stem Cell Transplant for Lymphoma Patients
Recruiting
PHASE2Up to 75InterventionalTreatmentMasonic Cancer Center, University of MinnesotaInvestigator-initiated
~150 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:EtoposideBCNUAraCMelphalanPeripheral blood stem cell transplantationG-CSF
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival Comparison
Measured over 3 years post transplant
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Veronika Bachanova, MD · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, University of Minnesota
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Eligible Diseases
Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification.
Patients in partial or complete remission following cell therapy will also be eligible.
NHL patients with resistant or refractory lymphoma (no PR following up to three cycles of combination chemotherapy) will not be eligible for transplant in this trial.
Lymphoblastic Lymphoma:
Mature B-cell Lymphoma
Mature T-Cell Lymphoma
Patients with histologically proven HL will be eligible for transplantation after failing prior therapy.
Patients with resistant disease (initial or at relapse): those who fail to achieve an objective partial response to three cycles of combination non-cross resistant chemotherapy will not be eligible for transplant in this trial.
For stage I/II patients treated with primary chemotherapy-radiation, they must have failed (no CR or progression after CR) at least one salvage combination chemotherapy treatment regimen
For advanced (stage III/IV) Hodgkin disease, patients must have failed an Adriamycin containing regimen (ABVD) or an alternative non-cross resistant regimen (e.g. MOPP)
Patients with any high-risk features will also be eligible, including those who:
Patients should receive chemotherapy to attempt to achieve CR or minimal disease state for all patients pre-transplantation. The use of up to three cycles of non-cross resistant combination chemotherapy is advised.
Residual areas of limited disease should be considered for radiotherapy after and not prior to transplantation. 3. HIV positive patients who are otherwise eligible for this study may be enrolled if they meet the following requirements:
Are 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.
Are on maximally active anti-HIV regimen to control disease as determined appropriate by the ID/HIV physicians. For the majority of patients, this will be a highly active anti-retroviral therapy (HAART)-type therapy including a protease inhibitor.
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 30 days of enrollment.
Performance Status: Karnofsky Performance Status ≥ 80% for patients ≥ 16 years of age or Lansky Play Score ≥ 80 for patients \< 16 years of age. Note: if poor performance status is due to lymphoma - KPS ≥ 60% or LPS ≥ 60 is acceptable
Organ Function
hemoglobin \> 8 gm/dL
WBC \> 2.5 x 109/L with an ANC \> 1.5 x 109/L off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
platelets \> 100 x 109/L without transfusion
bone marrow cellularity of \> 20% with \<5% involvement with tumor 2. Renal: GFR \> 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age 3. Hepatic: no history of severe prior or ongoing chronic liver disease. Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase \<5x upper limit of normal 4. Cardiac: free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. The ejection fraction by gated cardiac blood flow scan (MUGA) or Echocardiogram must be \>40% 5. Pulmonary: no significant obstructive airways disease (FEV1 must be ≥ 50%) and must have acceptable diffusion capacity (corrected DLCO \> 50% of predicted) 6. Central Nervous System: Patients with a history of CNS involvement by lymphoma or with relapsed primary CNS lymphoma will be eligible for Cy/TBI arm. Patients with active CNS disease are eligible if they have completed a standard treatment for CNS lymphoma and have no evidence of progressive CNS disease at the time of enrollment
Exclusion
Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Eligible for any higher priority transplant protocols
Chemotherapy resistant disease
Unrelated active infection
What this trial measures
- Progression Free Survival Comparison3 years post transplant
Compare progression-free survival (PFS) at 3 years post-transplant for patients who received who received a radiation free preparative regimen to the prior study MT2004-24 where NHL subjects received total body irradiation (TBI) as part of their preparative regimen.