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

NCT00345865 | Completed Phase 2 Results DMC

• 3 other identifiers: 2005LS048UMN-0508M72589UMN-MT2004-24
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Hodgkin lymphoma; non-Hodgkin lymphoma; HIV-associated lymphoma

Outcome Measures

Primary Outcomes (4)

• Number of Participants With 1 Year Progression Free Survival

  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.

  1 year

• Number of Participants With 2 Years Progression Free Survival

  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.

  2 years

• Number of Participants With 1 Year Overall Survival

  1 year

• Number of Participants With 2 Years Overall Survival

  2 years

Secondary Outcomes (1)

• Number of Participants With Hematopoietic Recovery After Transplantation

  Day 42

Study Arms (5)

NHL with irradiation

EXPERIMENTAL

Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.

Drug: cyclophosphamide; Procedure: peripheral blood stem cell transplantation; Radiation: irradiation therapy; Biological: G-CSF

HL without irradiation

EXPERIMENTAL

Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.

Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: peripheral blood stem cell transplantation; Biological: G-CSF

NHL - HIV infected with irradiation

EXPERIMENTAL

Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.

Drug: cyclophosphamide; Procedure: peripheral blood stem cell transplantation; Radiation: irradiation therapy; Biological: G-CSF

NHL - HIV infected without irradiation

EXPERIMENTAL

Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.

Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: peripheral blood stem cell transplantation; Biological: G-CSF

NHL without radiation and cyclosporine

EXPERIMENTAL

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; Drug: etoposide; Procedure: peripheral blood stem cell transplantation; Biological: G-CSF; Drug: Cytarabine

Interventions

carmustine DRUG

Day -6, 300 mg/m\^2 over 2 hour

Also known as: BNCU

HL without irradiation; NHL - HIV infected without irradiation; NHL without radiation and cyclosporine

cyclophosphamide DRUG

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.

Also known as: Cytoxan

HL without irradiation; NHL - HIV infected with irradiation; NHL - HIV infected without irradiation; NHL with irradiation

etoposide DRUG

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.

Also known as: VP-16

HL without irradiation; NHL - HIV infected without irradiation; NHL without radiation and cyclosporine

peripheral blood stem cell transplantation PROCEDURE

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.

Also known as: PBSC

HL without irradiation; NHL - HIV infected with irradiation; NHL - HIV infected without irradiation; NHL with irradiation; NHL without radiation and cyclosporine

irradiation therapy RADIATION

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.

NHL - HIV infected with irradiation; NHL with irradiation

G-CSF BIOLOGICAL

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.

Also known as: filgrastim

HL without irradiation; NHL - HIV infected with irradiation; NHL - HIV infected without irradiation; NHL with irradiation; NHL without radiation and cyclosporine

Cytarabine DRUG

100 mg/m\^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.

Also known as: Ara-C, cytosine arabinoside, Cytosar-U, Depocyt

NHL without radiation and cyclosporine

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Patients eligible for any higher priority transplant protocols
• Women who are pregnant or breast feeding
• Patients with chemotherapy resistant disease

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Lymphoma, Primary Effusion

Interventions

Carmustine; Cyclophosphamide; Etoposide; Peripheral Blood Stem Cell Transplantation; Granulocyte Colony-Stimulating Factor; Filgrastim; Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr.Veronika Bachanova
• Organization: Masonic Cancer Center, University of Minnesota

bach0173@umn.edu

612-625-5469

Study Officials

• Veronika Bachanova, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: August 24, 2005
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-07

Locations

US (1)