Phase 2
N=473
Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00345865 ↗Enrolled (actual)
473
Serious AEs
11.4%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With 1 Year Progression Free Survival — 112; 102; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carmustine (Drug); cyclophosphamide (Drug); etoposide (Drug); peripheral blood stem cell transplantation (Procedure); irradiation therapy (Radiation); G-CSF (Biological); Cytarabine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 1 Year Progression Free Survival |
112; 102; 1; 2; 116 | — |
| PRIMARY Number of Participants With 2 Years Progression Free Survival |
96; 91; 1; 1; 106 | — |
| PRIMARY Number of Participants With 1 Year Overall Survival |
139; 144; 1; 5; 128 | — |
| PRIMARY Number of Participants With 2 Years Overall Survival |
124; 140; 1; 4; 121 | — |
| SECONDARY Number of Participants With Hematopoietic Recovery After Transplantation |
171; 147; 2; 5; 145 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
- Karnofsky performance status: >80% (>60% if poor performance status is related to lymphoma)
- No evidence of serious organ dysfunction that is not attributable to tumor
- Central nervous system: Patients with a history of CNS involvement by lymphoma or with relapsed primary lymphoma will be eligible.
- Infection: Patients with serious uncontrolled infections at the time of transplant will be excluded.
- Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study. These patients are not eligible to receive rituximab as a component of their chemotherapy mobilization.
- HIV disease. Patients with HIV disease are eligible for this study provided that:
- Patients will be 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.
- Must be on a maximally active anti-HIV regimen
- 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 one month of enrollment.
- Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed NHL.
- Precursor B-cell or Precursor T-cell NHL
- Lymphoblastic lymphoma
- All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR)
- Mature B-cell Lymphomas:
- Small lymphocytic lymphoma (SLL) or Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Mantle Cell Lymphoma
- Burkitt's/Burkitt's like
- Mature T-cell lymphoma
- Hodgkin's lymphoma (HL)
- patients with histologically proven HL will be eligible for transplantation after failing prior therapy.
Exclusion Criteria
- Patients eligible for any higher priority transplant protocols
- Women who are pregnant or breast feeding
- Patients with chemotherapy resistant disease
Data sourced from ClinicalTrials.gov (NCT00345865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.