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Status:

UNKNOWN

A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)

Lead Sponsor:

Fondazione Italiana Linfomi - ETS

Conditions:

Relapsed Follicular Lymphoma

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or th...

Detailed Description

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT vs. ASCT in patients with FL in CR or PR after second or third...

Eligibility Criteria

Inclusion

  • Age 18-65
  • Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required)
  • Availability of BM and PB for Minimal Residual Disease (MRD) analysis (see Appendix I)
  • Relapsed or refractory disease after ≤ two chemotherapy lines at least one containing Rituximab (Rituximab maintenance is UNOTU considered a therapeutic line)
  • Clinical indication of treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria (see Appendix II)
  • ECOG performance status 0-2 (unless disease-related) (see Appendix III)
  • Availability of histological material for centralized revision
  • Laboratory values:
  • ANC ≥ 1500/mmc unless due to marrow involvement by lymphoma and/or platelets ≥ 100000/mmc unless due to marrow involvement by lymphoma
  • Serum creatinine ≤ 1.5 x ULN, unless it is disease related
  • Bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)
  • AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN if not lymphoma related or ≤ 5.0 x ULN in case of lymphoma liver involvement
  • Adequate cardiac function: LVEF \> 50% by echocardiography or MUGA scan
  • Not pregnant or breast-feeding
  • Willingness to use effective contraception during the study and 3 months after the end of treatment
  • No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 5 years (see Exclusion criteria 14)
  • Signed informed written consent

Exclusion

  • Grade IIIb FL, transformed FL or histologies different from FL
  • Previous treatment with \> two lines of chemotherapy ± rituximab Maintenance is UNOTU considered a therapeutics line)
  • Previous ASCT or RIT treatment
  • CNS involvement by lymphoma
  • HBV positivity with the exception of patients who are seropositive because of hepatitis B virus vaccination and patients HbcAb positive and HbsAg negative with undetectable serum HBV-DNA. Occult carriers: must receive treatment with Lamivudine 100 mg for the duration of treatment program and at least 12 months after treatment cessation; HBV-DNA levels and HBsAg will be monitored every month
  • HCV positivity with elevated transaminases or INR or APTT or active virus replication
  • HIV positivity
  • Any concurrent medical condition requiring long term use (\> one month) of systemic corticosteroids
  • Active bacterial, viral, or fungal infection requiring systemic therapy
  • Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent
  • Treatment with an experimental agent within 30 days prior to study entry
  • Myelosuppressive chemo or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy)
  • Major surgery other than diagnosis within 4 weeks prior to study entry
  • Previous i.v. or i.m. treatments with murine or animal derived antibodies

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2024

Estimated Enrollment :

159 Patients enrolled

Trial Details

Trial ID

NCT01827605

Start Date

January 1 2012

End Date

January 1 2024

Last Update

December 14 2023

Active Locations (38)

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Page 1 of 10 (38 locations)

1

A.O.U. San Martino

Genova, GE, Italy, 16132

2

Ematologia, A.O. San Gerardo

Monza, Milano, Italy, 20052

3

A.O. Niguarda

Milan, MI, Italy, 20162

4

IRCCS-Centro di riferimento oncologico UO di ematologia e Trapianto Cellule Staminali

Rionero in Vulture, Potenza, Italy, 85028