Oral azacitidine for Lymphoma, T-Cell, Peripheral

Phase-Based Estimates
1
Effectiveness
2
Safety
Cedars Sinai Medical Center, Los Angeles, CA
Lymphoma, T-Cell, Peripheral+10 More
Oral azacitidine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, T-Cell, Peripheral

Study Summary

This study is evaluating whether a drug called duvelisib may be better than chemotherapy for treating patients with peripheral T-cell lymphoma.

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Eligible Conditions

  • Lymphoma, T-Cell, Peripheral
  • Enteropathy-Associated T-Cell Lymphoma
  • Lymphoma
  • Immunoblastic Lymphadenopathy
  • Lymphoma, T-Cell
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Follicular T-cell Lymphoma (FTCL)
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Oral azacitidine will improve 1 primary outcome and 8 secondary outcomes in patients with Lymphoma, T-Cell, Peripheral. Measurement will happen over the course of Up to 6 months.

Year 5
Duration of response
Year 5
Overall Survival (OS)
Year 5
Event-free Survival (EFS)
Year 5
Progression-free Survival (PFS)
Up to 5 years
Correlation of follicular helper T-cell phenotype with response, PFS, EFS and OS
Incidence of adverse events
Up to 6 months
Complete remission (CR) rate
Overall response rate (ORR)
Patient reported outcomes (PROs)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Arm C (CHO[E]P)
Arm A (duvelisib, CHO[E]P)

This trial requires 170 total participants across 3 different treatment groups

This trial involves 3 different treatments. Oral Azacitidine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A (duvelisib, CHO[E]P)Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO BID on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Arm B (CC-486, CHO[E]P)Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Arm C (CHO[E]P)Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Azacitidine
FDA approved
Etoposide
FDA approved
Prednisone
FDA approved
Vincristine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Cedars Sinai Medical Center - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with a diagnosis of other PTCL subtype histologies other than those specified in the inclusion criteria are excluded including large cell transformation of mycosis fungoides
Patients will be stratified by presence or absence of TFH phenotype (i.e. diagnosis of AITL, TFH-PTCL, follicular T-cell lymphoma) based on local review of pathology. Determination of TFH phenotype can be defined by expression of two or more of the following markers CD10, BCL6, CXCL13, ICOS, and PD1 by immunohistochemistry
Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma
Patients with expression of CD30 in >= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted
Measurable disease as defined by the Lugano criteria
No prior systemic therapy for lymphoma (excluding corticosteroids)
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Platelet count >= 75,000/mm^3 (>= 50,000/mm^3 if secondary to bone marrow involvement from lymphoma per investigator assessment; the first 12 patients on each arm of the study must have platelets >= 75,000/mm^3 regardless of bone marrow involvement)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma, t-cell, peripheral?

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Lymphoma, t-cell, peripheral is treated through various modes of therapy including chemotherapy, radiation therapy, and immunotherapy. More recently, some lymphomas are treated with stem cell transplantation.

Unverified Answer

Can lymphoma, t-cell, peripheral be cured?

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Patients with lymphoma, t-cell, peripheral, have a good long-term prognosis. There might be a role for bone marrow transplantation, but no evidence on which to base it would be available. One of the major issues in the management of this patient group is the early stage at diagnosis, because there is very little evidence to advise on long-term management. The UK Lymphoma Multidisciplinary Group recommends an initial watch-and-wait policy following the current 'wait and see' regime. [Hodgkin's (n.d.).

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How many people get lymphoma, t-cell, peripheral a year in the United States?

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Between 25,000 and 80,000 Americans will be diagnosed with non-Hodgkin lymphoma in 2013, according to ACSC, whereas the number of people diagnosed with T-cell, Nodal, or Peripheral Lymphoma is expected to be less than 50.

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What causes lymphoma, t-cell, peripheral?

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The specific cause of T-cell lymphomas is not well understood, as many lymphomas are thought to arise from a defective, aberrant peripheral T-cell. Oncogenes appear to be implicated in a smaller proportion of cases. In non-Hodgkin's lymphoma, the incidence of non-mucosa-associated lymphatic tissue can approach that of B-cell lymphoma and may be due to differing etiologies. The most common, and frequently treated, non-Hodgkin's lymphoma is diffuse large-cell lymphoma (predominantly CD5+/leukaemia-associated "double-hit" lymphoproliferative disorder).

Unverified Answer

What is lymphoma, t-cell, peripheral?

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Primary peripheral B-cell lymphoma typically presents in persons older than 65 years. In this series, B-cell lymphoma accounted for 37% of all lymphomas, and the rate of lymphoma development was highest in patients younger than 60 years. The majority of secondary lymphomas exhibited a more favorable clinical behavior than in cases of primary B-cell lymphoma.

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What are the signs of lymphoma, t-cell, peripheral?

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Lymphoma, t-cell, peripheral, is an uncommon and complex condition characterised by several signs. The presence of a lump in the neck, a swollen neck, or in the area where lymph nodes would normally be located may be signs that the disease is more advanced than you may expect.

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What does oral azacitidine usually treat?

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These case reports demonstrate that a new oral therapy, azacitidine, is useful for the treatment of CMML and that it also has a favorable safety profile.

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Does lymphoma, t-cell, peripheral run in families?

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The occurrence of cancer in a first-degree relative is a risk factor for subsequent lymphoma in the first-degree relative. The risk is much greater if lymphoma evolves to CLL. A family history of lymphoma does not seem to influence the course of the disease in the lymphoma patient.

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Have there been any new discoveries for treating lymphoma, t-cell, peripheral?

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Although the chemotherapy and rituximab have the same effectiveness of achieving a complete remission with little side effect. Lymphoma, t-cell, peripheral is more challenging to treat compare to lymphoma, t-cell, other types.

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What are the chances of developing lymphoma, t-cell, peripheral?

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There are two forms of lymphoma. One is a common blood cancers (myeloma and lymphoma) which can be effectively treated. The other is t-cell lymphoma that can be effectively treated. Patients with less common cancers like non-Hodgkin lymphoma should be advised to undergo clinical exam annually as patients who develop less common cancers such as lymphoma can be hard to identify on a routine basis.

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What are the latest developments in oral azacitidine for therapeutic use?

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Oral AZA has been demonstrated to be effective in patients with t-cell acute lymphoblastic leukemia who had previously been treated with BHZL and are now on maintenance therapy with AZA alone or combination with other cytostatic agents. This finding indicates that AZA can be administered, in some patients, without an increase in the toxicities normally associated with this approach to treatment.

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Who should consider clinical trials for lymphoma, t-cell, peripheral?

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Results from a recent paper suggest a large proportion of lymphoma patients would benefit from clinical trials. Physicians should consider clinical trials when lymphoma presents with complications not related to the B-cell precursor disease itself, and when chemotherapy or other therapies should be considered.

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