Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: irradiation therapy Biological: G-CSF |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma |
- Percentage of patients achieving complete response [ Time Frame: Day 100, 1 Year, 2 Years ] [ Designated as safety issue: No ]response rate uses standard definition
- Prospective validation of the previously published formula used to estimate targeted collection of PBSC [ Time Frame: At end of study ] [ Designated as safety issue: No ]Outcome will be descriptive in nature.
- Immune reconstitution post-transplant in HIV-positive patients compared to HIV-negative patients [ Time Frame: At end of study ] [ Designated as safety issue: No ]Outcome will be descriptive in nature.
- Time to hematopoietic recovery after transplantation [ Time Frame: Days (range) ] [ Designated as safety issue: No ]return to ANC (absolute neutrophil count) more than 500 cells/millileter.
- Duration of response [ Time Frame: At end of study ] [ Designated as safety issue: No ]median calculation measured in months (range)
- Progression-free and overall survival [ Time Frame: 1 Year, 3 Years and 5 Years ] [ Designated as safety issue: No ]Includes those patients whose disease does not progress, and those alive at specified timeframes.
Estimated Enrollment: | 150 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | August 2014 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: NHL With Radiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
|
Drug: cyclophosphamide
NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days NHL or HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing. Other Name: Cytoxan
Procedure: peripheral blood stem cell transplantation
Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and without or without rituximab. Leukapheresis is to begin on Day 5.
Other Name: PBSC
Radiation: irradiation therapy
Patients undergo total body irradiation (TBI) twice daily on days -4 to -1.
Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF. Other Name: filgrastim
|
Experimental: NHL / HL Without Radiation
Patients with non Hodgkin's lymphoma or Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
|
Drug: carmustine
Day -6, 300 mg/m^2 over 1 hour
Other Name: BNCU
Drug: cyclophosphamide
NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days NHL or HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing. Other Name: Cytoxan
Drug: etoposide
Days -6 through -4, 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses.
Other Name: VP-16
Procedure: peripheral blood stem cell transplantation
Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and without or without rituximab. Leukapheresis is to begin on Day 5.
Other Name: PBSC
Biological: G-CSF
Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF. Other Name: filgrastim
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the disease-free survival and overall survival of patients with non-Hodgkin's or Hodgkin's lymphoma treated with autologous peripheral blood stem cell transplantation (PBSCT).
- Verify the safety and efficacy of autologous PBSCT in patients with HIV disease and relapsed lymphoma.
Secondary
- Evaluate immune reconstitution in HIV-positive patients undergoing autologous PBSCT and compare to immune reconstitution in HIV-negative patients.
- Predict the adequacy of peripheral blood stem cell (PBSC) harvest prior to flow analysis of a PBSC yield.
- Determine the time to engraftment for neutrophils and platelets.
OUTLINE:
- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF) alone: Patients not requiring further disease reduction receive G-CSF subcutaneously (SC) once daily on days 1-8. Patients undergo PBSC collection by leukapheresis on days 5-8. Patients who do not adequately mobilize with G-CSF alone proceed to chemo-mobilization.
Chemo-mobilization: Patients requiring further disease reduction receive 1 of 2 chemo-mobilization regimens.
- Patients with CD20+ non-Hodgkin's lymphoma (NHL) or lymphocyte predominant Hodgkin's lymphoma: Patients receive rituximab intravenously (IV) over 6-8 hours on day 1, ifosfamide IV over 2 hours and etoposide IV over 30 minutes on days 2-4, and carboplatin IV over 1 hour on day 2. Patients receive G-CSF SC once daily beginning on day 7 and continuing until leukapheresis is completed. Patients undergo PBSC collection by leukapheresis on days 12-15.
- All other patients: Patients receive ifosfamide IV over 2 hours and etoposide IV over 30 minutes on days 1-3 and carboplatin IV over 1 hour on day 1. Patients receive G-CSF SC once daily beginning on day 5 and continuing until leukapheresis is completed. Patients undergo PBSC collection by leukapheresis on days 12-15.
- Autologous PBSC transplantation (PBSCT) (Patients with NHL undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.
- Autologous PBSCT (Patients with Hodgkin's lymphoma or NHL not undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours twice daily on days -6 to -4. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.
- Post-transplant irradiation: Patients undergo post-transplant irradiation beginning on day 28. Persisting nodal masses ≥ 2 cm are treated with additional localized external beam irradiation.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
- 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
- Patients may be transplanted under this protocol using a syngeneic (identical) twin donor.
Exclusion Criteria:
- Patients eligible for any higher priority transplant protocols
- Women who are pregnant or breast feeding
- Patients with chemotherapy resistant disease
Contact: Timothy Krepski | 612-273-2800 | tkrepsk1@fairview.org |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Principal Investigator: | Veronika Bachanova, MD | Masonic Cancer Center, University of Minnesota |
Additional Information:
No publications provided
Responsible Party: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00345865 History of Changes |
Other Study ID Numbers: | 2005LS048, UMN-0508M72589, UMN-MT2004-24 |
Study First Received: | June 28, 2006 |
Last Updated: | November 6, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Masonic Cancer Center, University of Minnesota:
Hodgkin lymphoma non-Hodgkin lymphoma HIV-associated lymphoma |
Additional relevant MeSH terms:
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Cyclophosphamide Etoposide phosphate Etoposide |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on February 24, 2013