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Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02722733
Recruitment Status : Unknown
Verified March 2016 by Sebastian Giebel, Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Sebastian Giebel, Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's lymphoma and non-Hodgkin's lymphoma patients.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Drug: G-CSF (filgrastim) Drug: Cytosine arabinoside with G-CSF (filgrastim) Phase 3

Detailed Description:

Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (HL, NHL). AutoHSCT allows to further improve results of the therapy. Nowadays, 99% of the procedures are performed using peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate number of stem cells allowing hematopoietic recovery. The number of 2 × 10^6 CD34+ cells/kg is considered the minimal level in autoHSCT. There are two main mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy (cyclophosphamide (CY) at dose range 1.6 g/m2 is mainly used in HL and NHL setting). However, a proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for mobilization of hematopoietic stem cells has not been determined so far.

Randomized trials compare chemomobilization with the use of CY + G-CSF to G-CSF alone, which had been conducted so far, did not demonstrate clear advantage of addition of CY to the growth factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been shown to produce very high efficacy as a first or second-line mobilization regimen in patients with lymphoid malignancies. In a retrospective comparison, this strategy was significantly more effective than CY + G-CSF. This suggest that the type of chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of current study is to verify this hypothesis in randomized controlled trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Active Comparator: G-CSF (filgrastim)
1.G-CSF at 10 μg/kg per day (divided into two doses every 12 hours) subcutaneously for up to 7 days.
Drug: G-CSF (filgrastim)
Active Comparator: Cytosine arabinoside + G-CSF (filgrastim)
  1. Cytosine arabinoside will be administered as a 2-hour i.v. infusion at a dose of 0.4 g/m2 twice daily on days 1 and 2 (total dose 1.6 g/m2).
  2. G-CSF 5-10 μg/kg per day (divided into two doses every 12 hours) will be started on day 5 subcutaneously and continued until last leukapheresis.
Drug: Cytosine arabinoside with G-CSF (filgrastim)

Primary Outcome Measures :
  1. • The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm. [ Time Frame: After up to three leukaphereses (7-20 days after starting mobilization regimen). ]

Secondary Outcome Measures :
  1. Peak level of CD34+ cells in peripheral blood (cells/μl). [ Time Frame: 7-20 days after starting mobilization regimen. ]
  2. Total number of harvested CD34+cells/kg. [ Time Frame: After up to three leukaphereses (7-20 days after starting mobilization regimen). ]
  3. Number of leukaphereses needed to harvest target amount of stem cells. [ Time Frame: 7-20 days after starting mobilization regimen. ]
  4. The proportion of hematologic and non-hematologic complications. [ Time Frame: 1 month after transplantation. ]
  5. Duration of neutropenia < 0.5 x10^9/L. [ Time Frame: 1 month after transplantation. ]
  6. Number of blood transfusions needed. [ Time Frame: 1 month after transplantation. ]
  7. Duration of hospital stay. [ Time Frame: 1 month after transplantation. ]
  8. Time of neutrophil and platelet engraftment after autologous stem cel transplantation. [ Time Frame: 1 month after transplantation. ]
  9. Duration of thrombocytopenia <50 x 10 ^9/L. [ Time Frame: 1 month after transplantation. ]
  10. Number of days of antibiotics therapy. [ Time Frame: 1 month after transplantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Hodgkin's lymphoma and non-Hodgkin's lymphoma patients considered eligible for autologous stem cell transplantation procedure.
  2. Must not have achieved complete remission after first line of therapy or must have relapsed lymphoma.
  3. Must have received at least two lines of therapy including four or more cycles.
  4. Must have achieved a partial (PR) or complete remission (CR) .
  5. Must be 18-65 years of age.
  6. Must have World Health Organization performance status 0-1.
  7. Time from administration or discontinuation of any chemotherapy agent must be at least four weeks.
  8. Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 10^9/L, Platelet count >100 x 10^9/L.
  9. Serum creatinine < 1.5 x upper limit of normal (ULN), serum bilirubin < 1.5 ULN, serum aspartate transaminase (AST/SGOT) < 2.5 x ULN, serum alanine transaminase (ALT/SGPT) < 2.5 x ULN.
  10. Negative human immunodeficiency virus (HIV) infection test.
  11. Negative pregnancy test.
  12. Must understand and voluntarily sign informed consent form.

Exclusion Criteria:

  1. Failure of prior, first-line mobilization regimen.
  2. Infiltration of central nervous system.
  3. Bone marrow plasma cell infiltration of above 20%.
  4. Administration of nitrosourea derivatives (Carmustine, Lomustine) within 4 weeks before starting study treatment.
  5. Administration of growth-factor other than G-CSF Administration of G-CSF within 14 days before starting study treatment.
  6. Ongoing or active infection.
  7. Coexisting neoplasm, other than Hodgkin's or non-Hodgkin's lymphoma.
  8. Administration of radioimmunotherapy in past.
  9. Pregnant or lactating females.
  10. Patients treated with use of autologous or allogenic stem cell transplantation in the past.
  11. Positive human immunodeficiency virus (HIV) infection test.

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 identifier (NCT number): NCT02722733

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Contact: Katarzyna Soska, MD +48322788520

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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch Recruiting
Gliwice, Poland, 44-101
Contact: Sebastian Giebel, Prof MD    +48322788523   
Principal Investigator: Katarzyna Soska, MD         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center

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Responsible Party: Sebastian Giebel, Prof., MD, Maria Sklodowska-Curie Institute - Oncology Center Identifier: NCT02722733    
Other Study ID Numbers: HL/NHLMobil-COI-01
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Keywords provided by Sebastian Giebel, Maria Sklodowska-Curie Institute - Oncology Center:
Hodgkin's lymphoma
Non-Hodgkin's lymphoma
cytosine arabinoside
autologous stem cell transplantation
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents