Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

This study is currently recruiting participants.
Verified June 2012 by Polish Lymphoma Research Group

First Received on November 14, 2011.  
Last Updated on June 22, 2012  
History of Changes
This Clinical Trial Sponsored By: Polish Lymphoma Research Group
Information provided by (Responsible Party): Polish Lymphoma Research Group
ClinicalTrials.gov Identifier: NCT01481272
 

Purpose for Clinical Trial

It is expected that addition of anti-CD20 antibody – ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

Condition Study Intervention Clinical Trial Phase
Diffuse Large B Cell Lymphoma Drug: Ofatumumab
Drug: Etoposide
Drug: Ifosfamid
Drug: Mesna
Drug: Cytarabine
Drug: Methotrexate
Drug: Leukovorin
Drug: G-CSF
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Methotrexate
Cytarabine
Leucovorin Calcium
Methotrexate sodium
Mesna
Etoposide
Levoleucovorin
Etoposide phosphate
Ofatumumab

U.S. FDA Resources

Further study details as provided by Polish Lymphoma Research Group:

Primary Outcome Measures For Clinical Trial:

  • Response rate [ Time Frame: 12 months post-therapy ] [ Designated as safety issue: No ]
    Complete response + partial response

Secondary Outcome Measures For Clinical Trial:

  • Progression-free survival [ Time Frame: 12 month post-therapy ] [ Designated as safety issue: No ]
    Staying free of disease progression

  • Event-free survival [ Time Frame: 12 month post-therapy ] [ Designated as safety issue: No ]
    Staying free of event such as disease progression, relapse, death, starting new anticancer therapy, patient’s refusal to continue study treatment, Serious Adverse Event that causes discontinuation of study treatment

  • Overall survival [ Time Frame: 12 months post-therapy ] [ Designated as safety issue: No ]
    Time since entering the study till death of any reason

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months post-therapy ] [ Designated as safety issue: Yes ]
    Reporting Adverse Events and Serious Adverse Events

Estimated Enrollment: 77
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: Ofatumumab

    1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
    Other Name: Arzerra

    Drug: Etoposide

    60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles

    Drug: Ifosfamid

    1500mg/m2 or 1000mg/m2 (patients >/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles

    Drug: Mesna

    300mg/m2 or 200mg/m2 (patients >/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients >/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles

    Drug: Cytarabine

    2g/m2 or 0,5-1g/m2 (patients >/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles

    Drug: Methotrexate

    12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles

    Drug: Leukovorin

    15mg, po 24 hours after methotrexate it

    Drug: G-CSF

    5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC>1.0×109/l

Detailed Description:

The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under consideration for participation in this study must meet all of the following inclusion criteria:
  • Histologically confirmed CD20 positive diffuse large B-cell lymphoma.
  • Progressing or relapsed following prior treatment including but not limited to rituximab-CHOP chemotherapy regimen.
  • Not suitable for ASCT (age > 60 years, PS ≥ 2, prior ASCT as a part of the previous treatment for DLBCL, and/or other medical conditions that unable the patients to undergo the ASCT, e.g. NYHA II, creatinine clearance < 50 mL/min).
  • Age ≥ 18 years.
  • ECOG/ WHO performance status grades 0 – 3.
  • Resolution of toxicities from previous therapy to grade ≤ 1.
  • Written signed and dated informed consent prior to any study procedures being performed.

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