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

NCT02722733 | Unknown Phase 3 DMC

• 1 other identifier: HL/NHLMobil-COI-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Keywords

Hodgkin's lymphoma; Non-Hodgkin's lymphoma; mobilization; G-CSF; filgrastim; cytosine arabinoside; autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• • The proportion of patients with stem cell yield at least 2 × 10^6 CD34+ cells/kg in each treatment arm.

  After up to three leukaphereses (7-20 days after starting mobilization regimen).

Secondary Outcomes (10)

• Peak level of CD34+ cells in peripheral blood (cells/μl).

  7-20 days after starting mobilization regimen.

• Total number of harvested CD34+cells/kg.

  After up to three leukaphereses (7-20 days after starting mobilization regimen).

• Number of leukaphereses needed to harvest target amount of stem cells.

  7-20 days after starting mobilization regimen.

• The proportion of hematologic and non-hematologic complications.

  1 month after transplantation.

• Duration of neutropenia < 0.5 x10^9/L.

  1 month after transplantation.

Study Arms (2)

G-CSF (filgrastim)

ACTIVE COMPARATOR

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)

Cytosine arabinoside + G-CSF (filgrastim)

ACTIVE COMPARATOR

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)

Interventions

G-CSF (filgrastim) DRUG

G-CSF (filgrastim)

Cytosine arabinoside with G-CSF (filgrastim) DRUG

Cytosine arabinoside + G-CSF (filgrastim)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hodgkin's lymphoma and non-Hodgkin's lymphoma patients considered eligible for autologous stem cell transplantation procedure.
• Must not have achieved complete remission after first line of therapy or must have relapsed lymphoma.
• Must have received at least two lines of therapy including four or more cycles.
• Must have achieved a partial (PR) or complete remission (CR) .
• Must be 18-65 years of age.
• Must have World Health Organization performance status 0-1.
• Time from administration or discontinuation of any chemotherapy agent must be at least four weeks.
• Hemoglobin level \> 8 g/dl, Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, Platelet count \>100 x 10\^9/L.
• 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.
• Negative human immunodeficiency virus (HIV) infection test.
• Negative pregnancy test.
• Must understand and voluntarily sign informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch

Gliwice, 44-101, Poland

RECRUITING

Related Publications (5)

• Narayanasami U, Kanteti R, Morelli J, Klekar A, Al-Olama A, Keating C, O'Connor C, Berkman E, Erban JK, Sprague KA, Miller KB, Schenkein DP. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001 Oct 1;98(7):2059-64. doi: 10.1182/blood.v98.7.2059.

  PMID: 11567990 BACKGROUND

• Karanth M, Chakrabarti S, Lovell RA, Harvey C, Holder K, McConkey CC, McDonald D, Fegan CD, Milligan DW. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant. 2004 Sep;34(5):399-403. doi: 10.1038/sj.bmt.1704598.

  PMID: 15273706 BACKGROUND

• Sheppard D, Bredeson C, Allan D, Tay J. Systematic review of randomized controlled trials of hematopoietic stem cell mobilization strategies for autologous transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2012 Aug;18(8):1191-203. doi: 10.1016/j.bbmt.2012.01.008. Epub 2012 Jan 16.

  PMID: 22261379 BACKGROUND

• Kruzel T, Sadus-Wojciechowska M, Najda J, Czerw T, Glowala-Kosinska M, Holowiecki J, Giebel S. Very high efficacy of intermediate-dose cytarabine in combination with G-CSF as a second-line mobilization of hematopoietic stem cells. Int J Hematol. 2012 Aug;96(2):287-9. doi: 10.1007/s12185-012-1135-5. Epub 2012 Jul 14. No abstract available.

  PMID: 22797877 BACKGROUND

• Giebel S, Kruzel T, Czerw T, Sadus-Wojciechowska M, Najda J, Chmielowska E, Grosicki S, Jurczyszyn A, Pasiarski M, Nowara E, Glowala-Kosinka M, Chwieduk A, Mitrus I, Smagur A, Holowiecki J. Intermediate-dose Ara-C plus G-CSF for stem cell mobilization in patients with lymphoid malignancies, including predicted poor mobilizers. Bone Marrow Transplant. 2013 Jul;48(7):915-21. doi: 10.1038/bmt.2012.269. Epub 2013 Jan 7.

  PMID: 23292239 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Cytarabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; 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

Central Study Contacts

Katarzyna Soska, MD

CONTACT

+48322788520; katarzyna.soska@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

PL (1)