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T-cell LymphomasPhase 1/2NCT02341014

Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas

A Phase 1/2 study testing Carfilzomib, Romidepsin and Lenalidomide in people with T-cell Lymphomas and Relapsed or Refractory, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell lymphomas who are treated with carfilzomib, lenalidomide and romidepsin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-cell Lymphomas, Relapsed or Refractory
What is being tested?
Carfilzomib, Romidepsin and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
6 sitesUnited States
Study dates
2 Jan 2015to 11 Jan 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Pathologically confirmed B- or T-cell lymphomas at the enrolling institution, including stage ≥ Ib CTCL, which has relapsed or progressed after at least one systemic therapy.
  • Hodgkin lymphoma is allowed and will be classified as a B-cell lymphoma in the phase IIA portion.
  • Age ≥ 18,
  • Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment and adverse effects must have resolved to ≤Grade 1 or baseline. In the phase IIa portion, in progressing subjects, a 2 week washout may be allowed after discussion with the MSK Principal Investigator.
  • Previous radiation, hormonal therapy, and/or surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved. Lymph node or other diagnostic biopsies within 2 weeks are not considered exclusionary.
  • ECOG ≤ 2
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  • Meet the following laboratory criteria:
  • Absolute neutrophil count 1.0/mm³,
  • Platelet count 80 K/μ (in the Phase II portion, if thrombocytopenia is due to bone marrow involvement platelet count must be 50 K/μL),
  • Phase Ib subjects must have calculated creatinine clearance 50ml/min by Cockcroft-Gault formula, phase IIa subjects must have calculated creatinine clearance ≥ 40ml4/min by Cockcroft-Gault formula.
  • Total bilirubin 1.5 x upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) 3 x ULN
  • Measurable disease for phase IIa portion only.
  • Lymphoma (includes CTCL patients who are without evidence of the disease in the skin): CT or PET/CT by modified Cheson criteria with incorporation of PET.
  • CTCL: mSWAT >0, or absolute Sezary count ≥ 1000 cells/μL.
  • All study participants must be registered into the mandatory Revlimid REMS ® program, and be willing and able to comply with the requirements of the REMS ® program.
  • Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (< 7 days) must have been discontinued at least 6 days prior to study treatment. Stable ongoing corticosteroid use (≥ 30 days) up to an equivalent dose of 15 mg of prednisone is permissible.
  • Topical steroids that have been used for > 3 weeks may be continued (CTCL only).
  • Women of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  • A female of reproductive potential is a sexually mature female who:
  • has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).

Who cannot join

  • Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded. For eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant females. (Lactating females must agree not to breast feed while taking carfilzomib, lenalidomide or romidepsin).
  • Known hypersensitivity to thalidomide.
  • The development of erythema multiforme if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Prior use of lenalidomide if discontinued due to toxicity.
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  • Prior therapy with romidepsin if discontinued due to toxicity.
  • Prior therapy with carfilzomib if discontinued due to toxicity.
  • Prior therapy with a proteasome inhibitor if discontinued due to toxicity.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known seropositive and requiring anti-viral therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Concurrent malignancy requiring active therapy.
  • Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
  • Known central nervous system or meningeal involvement (in the absence of symptoms investigation into central nervous system involvement is not required).
  • The following known cardiac abnormalities:
  • Congenital long QT syndrome.
  • QTc/QTf interval ≥ 480 milliseconds; unless secondary to pacemaker or bundle branch block.
  • Myocardial infarction within 6 months of cycle one, day one (C1D1). Subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate.
  • Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block.
  • Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix B). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
  • An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix C) and/or ejection fraction <45% by, echocardiogram, or cardiac MRI.
  • A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD).
  • Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes.
  • Uncontrolled hypertension, i.e., blood pressure (BP) of ≥170/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria.
  • Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
  • Patients taking drugs that can cause significant QTc/QTf prolongation unless able to be switched to non-QTc/QTf prolonging medication or on a stable dose without significant QT prolongation (>470 msec).
  • Concomitant use of significant CYP3A4 inhibitors unless able to be switched to a non-CYP3A4 inhibiting medication.
  • Caution should be used when administering study drugs to patients taking medications significantly metabolized by these enzymes refer to (http://medicine.iupui.edu/clinpharm/ddis/clinical-table/ ) for clinically relevant medications. Particular attention should be paid to patients receiving warfarin. Patient should have coagulation parameters monitored regularly, and warfarin dose adjusted accordingly. If these drugs cannot be discontinued or replaced, enrollment may be allowed after discussion with MSK PI.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memoral Sloan Kettering Cancer Center

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York, 11570

Other trials in United States

About this study

Official title: Phase Ib/IIa Study of Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas

This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell lymphomas who are treated with carfilzomib, lenalidomide and romidepsin.

Being tested
Carfilzomib, Romidepsin, Lenalidomide
Keywords
Carfilzomib, Romidepsin, Lenalidomide, Lymphomas, 14-179
Medical subject headings
Lymphoma, T-Cell, Recurrence, Lymphoma

What participants receive

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

  • CarfilzomibDrug

    The initial dose of carfilzomib (cycle 1, day 1) given to any patient must be 20mg/m2 .

  • RomidepsinDrug

  • LenalidomideDrug

Study groups in NCT02341014
Study groupRoleWhat they receive
Carfilzomib, Romidepsin, LenalidomideExperimentalAll patients will be treated with romidepsin administered intravenously on days 1 and 8 of a 21-day cycle. Lenalidomide will be taken orally daily for days 1-14 of a 21-day cycle. The carfilzomib will be given weekly on days 1, and 8 of a 21-day cycle.
Receives: Drug: Carfilzomib; Drug: Romidepsin; Drug: Lenalidomide

What is being measured

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

  1. Maximum Tolerated Dose of Romidepsin

    Determine the MTD by NCI-CTCAE v4.0.

    Measured: 21 days

  2. Maximum Tolerated Dose of Lenalidomide

    Determine the MTD by NCI-CTCAE v4.0.

    Measured: 21 days

  3. Maximum Tolerated Dose of Carfilzomib

    Determine the MTD by NCI-CTCAE v4.0.

    Measured: 21 days

Secondary outcomes (1)

  1. Overall Response Rate (Orr) at the Maximum Tolerated Dose

    will be summarized using percentages and confidence intervals will be provided. ORR will be calculated based on the best response at any time during the course of treatment on this protocol.

    Measured: 1 year

Timeline

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

  1. First posted19 Jan 2015 (estimated)
  2. Study start2 Jan 2015
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341014
Sponsor's protocol ID
14-179
Status last verified
Jan 2023
First submitted
14 Jan 2015
Last updated
4 Apr 2024

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carfilzomib, Romidepsin and Lenalidomide in people with T-cell Lymphomas and Relapsed or Refractory, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

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 20 inclusion and 29 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: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose of Romidepsin (time frame: 21 days). The study lists 3 primary outcomes in all. 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 NCT02341014.

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 4 Apr 2024.

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