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New stem cell approach aims to beat lymphoma without radiation

NCT ID NCT03125642

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests a stem cell transplant procedure for people with Hodgkin or non-Hodgkin lymphoma, including those with HIV. Participants receive high-dose chemotherapy followed by an infusion of their own stem cells. The goal is to see if this radiation-free approach can improve survival and reduce side effects compared to older methods.

What this could mean

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

Active substance
chemotherapy (etoposide, carmustine, cytarabine, melphalan) followed by stem cell transplant
What this could lead to
If successful, this approach could offer a better, radiation-free way to control lymphoma and improve long-term survival for patients, including those with HIV.
What could go wrong
This is a mid-stage trial with only 150 participants, so results may not apply to everyone. The chemotherapy has serious side effects, and the transplant carries risks like infection and organ damage.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Apr 2017

Expected to finish

Apr 2027

An estimate. End dates often move.

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

Up to 75 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: * Eligible Diseases 1. Non-Hodgkin's Lymphoma (NHL) * 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: 1. All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR) 2. Patients with any high-risk features will be eligible in first complete remission 3. High risk features include: Stage IV, LDH \>2 x upper limit of normal, ≥ 2 extranodal sites * Mature B-cell Lymphoma 1. Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2 2. Diffuse Large B-Cell Lymphoma: in ≥ CR2 or ≥ PR1; a high intermediate or high IPI (≥ 2 for age-adjusted IPI or ≥3 for IPI) at diagnosis and double-hit or triple-hit lymphoma will be eligible in first CR; transformed lymphoma from FL (or other indolent lymphoma) or chronic lymphocytic leukemia will be eligible if chemosensitive and bone marrow is negative 3. Mantle Cell Lymphoma: in first or greater CR or PR 4. Burkitt's/Burkitt's like: all patients except localized lymphoma will be eligible any time after initial therapy (after achievement of first complete remission), or in partial remission if they fail to achieve CR; patients with localized (stage I or Ziegler stage A) will be eligible only if they fail to achieve CR1 or after relapse * Mature T-Cell Lymphoma 1. Chemosensitive T-cell lymphomas including Primary T-cell not otherwise specified angioimmunoblastic, and ALK-positive anaplastic large cell, will be eligible after initial therapy, whether or not CR is achieved. 2. Mycosis fungoides/Sezary syndrome will be eligible in ≥CR2/PR2 2. Hodgkin Lymphoma (HL) * 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: 1. fail to achieve complete remission with initial combination chemotherapy 2. have bulky disease after initial therapy (chemotherapy or radiation) defined as residual mediastinal mass ≥ 5 cm or other residual mass ≥ 10 cm accompanied by other features of persisting disease (e.g., PET scan positive; high LDH; enlarging on serial x-rays or biopsy positive) will be eligible - if feasible, persistent disease should be proven by biopsy * 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 1\. No evidence of serious organ dysfunction that is not attributable to tumor including: 1. Hematologic: * 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 * Other Inclusion Criteria 1. At least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas 2. Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment 3. Patients who are carriers of Hepatitis B will be included in this study 4. Voluntary written consent Exclusion Criteria: * 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

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Masonic Cancer Center, University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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