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NCT00345865 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-07-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With 1 Year Progression Free Survival

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outcome · POSTED

Number of Participants With 2 Years Progression Free Survival

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outcome · POSTED

Number of Participants With 1 Year Overall Survival

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outcome · POSTED

Number of Participants With 2 Years Overall Survival

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outcome · POSTED

Number of Participants With Hematopoietic Recovery After Transplantation

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
75 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
    intervention Names
    1. Drug: cyclophosphamide
    2. Procedure: peripheral blood stem cell transplantation
    3. Radiation: irradiation therapy
    4. Biological: G-CSF
    label
    NHL with irradiation
    type
    EXPERIMENTAL
  2. description
    Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
    intervention Names
    1. Drug: carmustine
    2. Drug: cyclophosphamide
    3. Drug: etoposide
    4. Procedure: peripheral blood stem cell transplantation
    5. Biological: G-CSF
    label
    HL without irradiation
    type
    EXPERIMENTAL
  3. description
    Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
    intervention Names
    1. Drug: cyclophosphamide
    2. Procedure: peripheral blood stem cell transplantation
    3. Radiation: irradiation therapy
    4. Biological: G-CSF
    label
    NHL - HIV infected with irradiation
    type
    EXPERIMENTAL
  4. description
    Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
    intervention Names
    1. Drug: carmustine
    2. Drug: cyclophosphamide
    3. Drug: etoposide
    4. Procedure: peripheral blood stem cell transplantation
    5. Biological: G-CSF
    label
    NHL - HIV infected without irradiation
    type
    EXPERIMENTAL
  5. description
    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).
    intervention Names
    1. Drug: carmustine
    2. Drug: etoposide
    3. Procedure: peripheral blood stem cell transplantation
    4. Biological: G-CSF
    5. Drug: Cytarabine
    label
    NHL without radiation and cyclosporine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. HL without irradiation
    2. NHL - HIV infected without irradiation
    3. NHL without radiation and cyclosporine
    description
    Day -6, 300 mg/m\^2 over 2 hour
    name
    carmustine
    other Names
    1. BNCU
    type
    DRUG
  2. arm Group Labels
    1. HL without irradiation
    2. NHL - HIV infected with irradiation
    3. NHL - HIV infected without irradiation
    4. NHL with irradiation
    description
    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.
    name
    cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  3. arm Group Labels
    1. HL without irradiation
    2. NHL - HIV infected without irradiation
    3. NHL without radiation and cyclosporine
    description
    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.
    name
    etoposide
    other Names
    1. VP-16
    type
    DRUG
  4. arm Group Labels
    1. HL without irradiation
    2. NHL - HIV infected with irradiation
    3. NHL - HIV infected without irradiation
    4. NHL with irradiation
    5. NHL without radiation and cyclosporine
    description
    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.
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBSC
    type
    PROCEDURE
  5. arm Group Labels
    1. NHL - HIV infected with irradiation
    2. NHL with irradiation
    description
    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.
    name
    irradiation therapy
    type
    RADIATION
  6. arm Group Labels
    1. HL without irradiation
    2. NHL - HIV infected with irradiation
    3. NHL - HIV infected without irradiation
    4. NHL with irradiation
    5. NHL without radiation and cyclosporine
    description
    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.
    name
    G-CSF
    other Names
    1. filgrastim
    type
    BIOLOGICAL
  7. arm Group Labels
    1. NHL without radiation and cyclosporine
    description
    100 mg/m\^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.
    name
    Cytarabine
    other Names
    1. Ara-C
    2. cytosine arabinoside
    3. Cytosar-U
    4. Depocyt
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
473
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
    measure
    Number of Participants With 1 Year Progression Free Survival
    time Frame
    1 year
  2. description
    Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
    measure
    Number of Participants With 2 Years Progression Free Survival
    time Frame
    2 years
  3. measure
    Number of Participants With 1 Year Overall Survival
    time Frame
    1 year
  4. measure
    Number of Participants With 2 Years Overall Survival
    time Frame
    2 years
secondary Outcomes
  1. description
    return to ANC (absolute neutrophil count) more than 500 cells/milliliter.
    measure
    Number of Participants With Hematopoietic Recovery After Transplantation
    time Frame
    Day 42
Full 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.
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 5 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 4 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 and cyclophosphamide): Patients receive camustine IV over 2 hours on days -6, etoposide IV over 2 hours twice daily on days -5 to -2, and melphalan over 1 hour on day -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 PBSC transplantation (PBSCT) (Patients with HL not undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -6 to -3, camustine IV over 2 hours 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. * Post-transplant Rituximab therapy: patients with CD20+ NHL may undergo Rituximab maintenance starting between day +45 and +90 and being repeated at day +180 ± 14 days. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice