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

March 24, 2016 updated by: Sebastian Giebel, Maria Sklodowska-Curie National Research Institute of Oncology

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Gliwice, Poland, 44-101
        • Recruiting
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
        • Contact:
        • Principal Investigator:
          • Katarzyna Soska, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• 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).
After up to three leukaphereses (7-20 days after starting mobilization regimen).

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL/NHLMobil-COI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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