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Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

ConditionEarly Stage Follicular Lymphoma WHO Grade 1/2 or 3a
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeidelberg University

About this trial

The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems to show a high CR rate based on the 50% of the patients. This is in contrast to the FORT trial, which showed an inferiority of the 4 Gy dose compared to the standard dose (24 Gy) in terms of response and progression free survival.

The goal of the FORTplus trial is to prove (1) the non-inferiority of LDRT (4Gy) in a combined approach with an anti-CD20-antibody. In case of non-inferiority, a possible (2) superiority of the Obinutuzumab + LDRT should be tested against Rituximab + standard dose using the same test set.

The radiation dose can significantly be reduced to 16% of the standard dose if (1) is confirmed. Knowing the data of the FORT trial, this would have a significant influence on the treatment of the disease worldwide even if the difference in the CR rate at week 18 is not as high as currently in the historical comparison expected.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)

Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)

Age: ≥18 years

ECOG: 0-2

Disqualifiers

Extra nodal manifestation of follicular lymphoma

Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago)

Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease

Severe psychiatric disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard

    Radiation

    12 x 2 Gy involved site radiotherapy plus Rituximab

  • Experimental

    Radiation

    2 x2 Gy involved site radiotherapy plus Obinutuzumab

  • Standard

    Drug

    Rituximab with 12 x 2 Gy involved site radiotherapy

  • Experimental

    Drug

    Obinutuzumab with 2 x2 Gy involved site radiotherapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: StandardActive comparator 2 interventions
Group B: ExperimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Morphologic complete response

Rate of morphologic complete response based on CT scan in patients with initially remaining lymphoma

Time frame
Week 18

Secondary outcomes

1

Metabolic complete response

Rate of metabolic complete response based on FDG PET in patients with initially remaining lymphoma

Time frame
week 18
2

Morphologic response

Morphologic CR in patients with initially remaining lymphoma

Time frame
Month 6
3

PFS

Progression-free survival (PFS) of each treatment arm

Time frame
2 years
4

Frequency and extent of Toxicity

Toxicity (NCI-CTC criteria, version 5) of all patients

Time frame
until month 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heidelberg University

Lead sponsor

Source ClinicalTrials.gov
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