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New treatment option for Non-Hodgkin Lymphoma
Official title Auto Stem Cell Transplant for Lymphoma Patients
ClinicalTrials.gov ID: NCT03125642
What this study is testing
What is Etoposide?
Etoposide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Also referred to as VP-16.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 75
You may be able to join if
- 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...
You likely can't join if
- Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out...
- Eligible for any higher priority transplant protocols
- Chemotherapy resistant disease
- Unrelated active infection
See the full eligibility criteria
- 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:
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 ≥...
- 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...
- 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...
- Other 1. 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.