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Non-Hodgkin LymphomaPhase 2NCT03125642

Auto Stem Cell Transplant for Lymphoma Patients

A Phase 2 study testing Etoposide, BCNU and AraC in people with Non-Hodgkin Lymphoma and Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase II study of autologous transplant for patients with Hodgkin (HL) and non-Hodgkin lymphomas (NHL) including those who are HIV positive. Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
What is being tested?
Etoposide, BCNU and AraC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
20 Apr 2017to 30 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible Diseases
  • 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:
Show all 50Show fewer
  • All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR)
  • Patients with any high-risk features will be eligible in first complete remission
  • High risk features include: Stage IV, LDH >2 x upper limit of normal, ≥ 2 extranodal sites
  • Mature B-cell Lymphoma
  • Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2
  • 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
  • Mantle Cell Lymphoma: in first or greater CR or PR
  • 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
  • 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.
  • Mycosis fungoides/Sezary syndrome will be eligible in ≥CR2/PR2
  • 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:
  • fail to achieve complete remission with initial combination chemotherapy
  • 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.
  • 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:
  • 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
  • Renal: GFR > 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age
  • 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
  • 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%
  • Pulmonary: no significant obstructive airways disease (FEV1 must be ≥ 50%) and must have acceptable diffusion capacity (corrected DLCO > 50% of predicted)
  • 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
  • At least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
  • 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
  • Patients who are carriers of Hepatitis B will be included in this study
  • Voluntary written consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy Krepski contact

612-273-2800

tkrepsk1@fairview.org

United States1 site, 1 recruiting

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

    Timothy Krepski, 612-273-2800, tkrepsk1@fairview.org

    Veronika Bachanova, MD

    Recruiting

Other trials in United States

About this study

Official title: Autologous Stem Cell Transplant In Patients With Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

This is a phase II study of autologous transplant for patients with Hodgkin (HL) and non-Hodgkin lymphomas (NHL) including those who are HIV positive.

Keywords
Lymphoblastic Lymphoma, Mature B-cell Lymphomas, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Burkitt's/Burkitt's like, Mature T-Cell Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtoposideDrug

    Also called VP-16

    BEAM: 100 mg/m^2 IV over 2 hours BID on Days -5, -4, -3, -2 | CBV: 150 mg/m^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4

  • BCNUDrug

    Also called Carmustine

    BEAM \& CBV: 300 mg/m^2 IV over over 2 hours on Day -6

  • AraCDrug

    Also called Cytarabine, cytosine arabinoside, Cytosar-U, Depocyt

    BEAM: 100 mg/m^2 IV over 1 hour BID on Days -5, -4, -3, -2

  • MelphalanDrug

    Also called Alkeran

    BEAM: 140 mg/m^2 IV over 20 minutes on Day -1

  • Peripheral blood stem cell transplantationProcedure or surgery

    Also called PBSC

    All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF.

  • G-CSFBiological

    Also called filgrastim

    All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is >2500 x 10^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm^3

  • CyclophosphamideDrug

    Also called Cytoxan

    CBV: 1.5 gm/M^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 | CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6

  • Total Body IrradiationRadiation

    Also called TBI

    CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

Study groups in NCT03125642
Study groupRoleWhat they receive
BEAM: NHL & HLExperimentalBCNU, etoposide, Ara-C and melphalan (BEAM) for all NHL and those HL patients who are unable to receive CBV
Receives: Drug: Etoposide; Drug: BCNU; Drug: AraC; Drug: Melphalan; Procedure: Peripheral blood stem cell transplantation; Biological: G-CSF
CBV: HLExperimentalCyclophosphamide, BCNU and VP-16 (CBV) for HL patients
Receives: Drug: Etoposide; Drug: BCNU; Drug: Cyclophosphamide
CY/TBIExperimentalCyclophosphamide/Total Body Irradiation (CY/TBI) for patients with recent history of CNS lymphoma or those with allergies/contra-indications to agents used in BEAM
Receives: Procedure: Peripheral blood stem cell transplantation; Biological: G-CSF; Drug: Cyclophosphamide; Radiation: Total Body Irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival Comparison

    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.

    Measured: 3 years post transplant

Secondary outcomes (6)

  1. Overall Survival

    Incidence of survival

    Measured: 3 years post transplant

  2. Treatment related mortality

    Incidence of treatment related mortality

    Measured: 6 months post transplant

  3. Treatment related mortality

    Incidence of treatment related mortality

    Measured: 1 year post transplant

  4. Secondary malignancies

    Cumulative incidence of secondary malignancies

    Measured: 3 years post transplant

  5. Neutrophil engraftment

    Average days to neutrophil engraftment

    Measured: Day +1 to engraftment

  6. Platelet engraftment

    Average days to platelet engraftment

    Measured: Day +1 to engraftment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start20 Apr 2017
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03125642
Sponsor's protocol ID
2016LS132
Other IDs
MT2016-11C
Status last verified
Oct 2025
First submitted
19 Apr 2017
Last updated
4 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etoposide, BCNU and AraC in people with Non-Hodgkin Lymphoma and Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota 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 50 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy Krepski (612-273-2800, tkrepsk1@fairview.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival Comparison (time frame: 3 years post transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03125642.

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 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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