Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00345865

Recruitment Status : Active, not recruiting

First Posted : June 29, 2006

Last Update Posted : February 13, 2018

Sponsor:

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Drug: carmustine Drug: cyclophosphamide Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: irradiation therapy Biological: G-CSF Drug: Cytarabine	Phase 2

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	421 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
Study Start Date :	August 2005
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma Lymphoma AIDS Related

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: NHL with irradiation 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. 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 with 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. > 1000 cGy to whole lung, kidney, or abdominal bath. > 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes. > 3600 cGy to whole brain. 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
Experimental: HL without irradiation Patients with 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 2 hour Other Name: BNCU Drug: cyclophosphamide NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. 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 NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4. 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 with 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
Experimental: NHL without radiation and cyclosporine Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).	Drug: carmustine Day -6, 300 mg/m^2 over 2 hour Other Name: BNCU Drug: etoposide NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4. 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 with 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 Drug: Cytarabine 100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen. Other Names: Ara-C cytosine arabinoside Cytosar-U Depocyt

Outcome Measures

Primary Outcome Measures :

Percentage of patients achieving complete response [ Time Frame: Day 100, 1 Year, 2 Years ]
response rate uses standard definition

Secondary Outcome Measures :

Prospective validation of the previously published formula used to estimate targeted collection of PBSC [ Time Frame: At end of study ]
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 ]
Outcome will be descriptive in nature.
Time to hematopoietic recovery after transplantation [ Time Frame: Days (range) ]
return to ANC (absolute neutrophil count) more than 500 cells/milliliter.
Duration of response [ Time Frame: At end of study ]
median calculation measured in months (range)
Progression-free and overall survival [ Time Frame: 1 Year, 3 Years and 5 Years ]
Includes those patients whose disease does not progress, and those alive at specified timeframes.

Eligibility Criteria

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Ages Eligible for Study:	up to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345865

Locations


United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators


Principal Investigator:	Veronika Bachanova, MD	Masonic Cancer Center, University of Minnesota

More Information


Responsible Party:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00345865 History of Changes
Other Study ID Numbers:	2005LS048 UMN-0508M72589 ( Other Identifier: IRB, University of Minnesota ) UMN-MT2004-24 ( Other Identifier: Blood and Marrow Transplantation Program )
First Posted:	June 29, 2006 Key Record Dates
Last Update Posted:	February 13, 2018
Last Verified:	December 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:


Hodgkin lymphoma non-Hodgkin lymphoma HIV-associated lymphoma

Additional relevant MeSH terms:


Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Cytarabine Carmustine Etoposide phosphate Etoposide Lenograstim Immunosuppressive Agents Immunologic Factors	Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents

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