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DLBCLPhase 2itTRIOlymNCT02488512

Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas

A Phase 2 study testing 90Y-DOTATOC in people with DLBCL and MCL, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, single arm,single centre open-label, phase II study in relapsed or refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies, included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous stem-cell transplantation (ASCT), treated with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL, MCL, Recurrent Disease
What is being tested?
90Y-DOTATOC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteItaly
Study dates
22 Dec 2016to 23 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female, aged >18 years.
  • Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments.
  • Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT with 68Ga-DOTATOC images demonstrate a significant uptake in the tumour (SSR-positive tumour).
  • Patients must have at least one bidimensional measurable lesion with long axis > 15 mm at CT scan (MRI is allowed only if CT scan cannot be performed), according to Cheson Criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy of at least 3 months.
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  • Adequate cardiac function as assessed at echocardiography and ECG.
  • Conserved hematological, liver and renal parameters, and in particular: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X UNL (upper normal limit), Alanine aminotransferase (ALT) <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL
  • Patients must not have received other treatments with radiopeptides (e.g. 111In-pentetreotide, 177Lu-DOTATATE, 131I-MIBG).
  • If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 7 days of starting treatment.

Who cannot join

  • Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
  • Bone marrow invasion > 25 %.
  • Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers); subjects must be free from other neoplasms at least 3 years. All acute toxic effects of any prior therapy (including surgery radiation therapy,chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
  • Evidence of myelodysplastic syndrome or other hematologic diseases
  • Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks.
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HbsAg). In addition, if negative for HBsAg but Hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a hepatitis B virus (HBV) DNA test will be performed and if positive the subject will be excluded. Any patient with HBcAb positivity will receive anti viral prophylaxis during the study, according to the procedures suggested by local Hepatology service.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition.
  • Previous autologous stem cell transplant in the last 2 months.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Nuclear Medicin Division, IRST IRCCS

    Meldola, FC, 47014

Other trials in Italy

About this study

Official title: Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell (DLBCL) and Mantle Cell Lymphomas (MCL)

This is a prospective, single arm,single centre open-label, phase II study in relapsed or refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies, included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with 90Y-Dotatoc.

Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.

35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).

Read the detailed description

PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) WITH 90Y-DOTATOC IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL AND MANTLE CELL LYMPHOMAS.

This is a prospective, single arm, open-label, phase II study. It is estimated that a maximum of 35 patients will be enrolled in 36 months; the treatment efficacy will be tested in 18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed; if > 2 objective responses will be observed, a total of 35 patients will be enrolled.

Follow up period is 48 months.

Single-center

The primary objective is the evaluation of objective response rate (ORR). of Y-PRRT in relapsed or refractory DLBCl and MCL NHL, not suitable to other therapies, included HDCT, or patients relapsed after HDCT with ASCT.

The secondary objectives are toxicity (acute and late), progression free survival, overall survival and Quality of life.

35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).

Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.

The study will be conducted following the Optimal Two Stage Design assuming the true response probability:

  • under H0 (p0) <=10%
  • under H1 (p1) >=30% and considering alpha=0.05 and power=0.90.
Being tested
90Y-DOTATOC
Keywords
Relapsed/refractory diffuse large b cell, Relapsed/refractory mantle cell lymphomas, DLBCL, MCL, 90Y-DOTATOC, SSR-positive tumour
Medical subject headings
Recurrence, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 90Y-DOTATOCDrug

    Also called Y-PRRT

    Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi) [45-46], divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The activity to be administered will be measured in a dose calibrator, properly calibrated for the 90Y-radionuclide.

Study groups in NCT02488512
Study groupRoleWhat they receive
90Y-DOTATOCExperimental90Y-DOTATOC
Receives: Drug: 90Y-DOTATOC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate (ORR)

    ORR will be calculated according to Response Evaluation Criteria in Non Hodgkin's lymphoma according to Cheson Criteria

    Measured: up to 48 months

Secondary outcomes (5)

  1. acute toxicity evaluation

    The acute toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (48 months).

    Measured: up to 48 months

  2. progression free survival (PFS)

    PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation

    Measured: up to 48 months

  3. overall survival (OS)

    OS is defined as the time from treatment start to the time of death from any cause. Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.

    Measured: up to 48 months

  4. Quality of Life (QLQ)

    Quality of life will be evaluated with Version 3.0 European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

    Measured: up to 48 months

  5. late toxicity evaluation

    The late toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (48 months) .

    Measured: up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study start22 Dec 2016
  3. Primary completion23 Feb 2018
  4. Study completion23 Feb 2018

Why it stopped: critical low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02488512
Sponsor's protocol ID
IRST202.02
Acronym
itTRIOlym
Status last verified
Mar 2018
First submitted
19 Jun 2015
Last updated
19 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Y-DOTATOC in people with DLBCL and MCL, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: critical low recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (ORR) (time frame: up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02488512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.

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