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Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

Primary Purpose

Folliculotropic Mycosis Fungoides, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Durvalumab
Laboratory Biomarker Analysis
Lenalidomide
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Folliculotropic Mycosis Fungoides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorized representative
  • Registered into Revlimid REMS program
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
  • Relapsed/refractory disease
  • Failed >= 2 prior systemic therapies *NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin

CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY

  • Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF; Phase 2: >= stage IB

    • Stage of disease according to TNMB classification
    • Pathology report must be diagnostic or be consistent with MF/SS criteria
    • SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
    • For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used
  • Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count
  • Baseline skin biopsy taken within 6 months available for central review submission

PERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY

  • Histologically confirmed PTCL as defined by World Health Organization (WHO) 2008 criteria
  • Measurable and/or evaluable disease per Lugano Classification
  • Absolute neutrophil count (ANC) >= 1000/mm^3

    * Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement

  • Platelets >= 100,000/mm^3

    * Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement

  • Total serum bilirubin =< 2.2 mg/dL
  • Aspartate aminotransferase (AST) =< 2 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) =< 2 x ULN
  • Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula
  • If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =< 1.5 x ULN

    * If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants

  • Female of childbearing potential: negative urine or serum pregnancy test

    * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

  • Female of child bearing potential: willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication

    * Childbearing potential defined as not being surgically sterilized or have not been free from menses for > 1 year

  • Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria:

  • Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines
  • Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs)
  • Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy
  • Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
  • Any skin-directed therapy within 14 days prior to initiating protocol therapy
  • Any radiation therapy within 21 days prior to initiating protocol therapy
  • Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion:

    • Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
    • Systemic corticosteroids at physiologic doses of < 10 mg/day of prednisone or equivalent
  • Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy
  • History of pneumonitis (non-infectious) that required steroids or current pneumonitis
  • Disease free of prior malignancies for >= 5 years with the exception of:

    • Currently treated squamous cell and basal cell carcinoma of the skin
    • Carcinoma in situ of the cervix, or
    • Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or
    • Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or
    • Any other malignancy that has/have been curatively treated with surgery and/or localized radiation
  • Allergic reaction/ hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab
  • Female only: pregnant or lactating
  • Prior stem cell transplantation
  • Acute infection requiring systemic treatment
  • Known history of human immunodeficiency virus (HIV) infection
  • Active hepatitis B or C infection
  • Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
  • Current peripheral neuropathy >= grade 2
  • Renal failure requiring hemodialysis or peritoneal dialysis
  • Unstable cardiac disease as defined by one of the following:

    • Cardiac events such as myocardial infarction (MI) within the past 6 months
    • NYHA (New York Heart Association) heart failure class III-IV
    • Uncontrolled atrial fibrillation or hypertension
  • Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
  • Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:

    • Vitiligo or alopecia;
    • Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or
    • Psoriasis not requiring systemic treatment
  • History of primary immunodeficiency
  • Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide
  • Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
  • In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sites / Locations

  • City of Hope Medical CenterRecruiting
  • Memorial Sloan-Kettering Cancer Center
  • Thomas Jefferson University Hospital
  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (durvalumab)

Arm II (durvalumab, lenalidomide)

Arm Description

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

CTCL specific response assessed by Lugano Classification
CTCL response will be used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool will be used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification will be used.
Dose limiting toxicity assessed by CTCAE version 4.03
Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Duration of complete response
Event-free survival
Will be estimated using the product-limit method of Kaplan and Meier.
Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03
Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
ORR defined as proportion of patients with complete response (CR) and partial response (PR)
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier.
Progression free survival
Response duration
95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapies.
Time to response

Secondary Outcome Measures

Pruritus assessment
Changes in pruritus VAS score will be assessed using descriptive statistics.

Full Information

First Posted
January 4, 2017
Last Updated
January 12, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03011814
Brief Title
Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma
Official Title
A Phase 1/2 Trial of Durvalumab (MEDI4736) When Given as a Single Agent or in Combination With Lenalidomide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma, Including Cutaneous T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (recommended phase 2 dose, RP2D) of lenalidomide, when given in combination with fixed-dose durvalumab. (Phase 1) II. To assess the safety and tolerability of the lenalidomide/durvalumab regimen, and accompanying dose modification plan, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase 1) III. To evaluate the anti-tumor activity durvalumab (MEDI4736) as single agent therapy and as part of combination therapy (+lenalidomide); activity assessed by overall response rate (ORR). (Phase 2) SECONDARY OBJECTIVES: I. To estimate and assess response duration and survival probabilities (overall and event-free). (Phase 2) II. To summarize and assess toxicities by type, frequency, severity, attribution, time course and duration. (Phase 2) III. To assess clinically meaningful reduction in pruritus (CMRP) in patients with CTCL (critical quality of life measure). (Phase 2) TERTIARY OBJECTIVES: I. To identify the malignant CD4+ T cells within the skin microenvironment. II. To characterize the spatial and functional relationship of malignant T cells with other immune cells, their expression of key immune checkpoints and correlate with response. III. To identify aberrantly expressed micro(mi) ribonucleic acid (RNA)s involved in cutaneous T-cell lymphoma (CTCL) and messenger (m)RNAs that may predict response and/or treatment-related toxicity. IV. To evaluate whether or not the identified miRNAs are involved in regulating key immune checkpoints. OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients are randomized to 1 of 2 arms, ARM I: Patients receive durvalumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 28 days (+/- 3) for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Folliculotropic Mycosis Fungoides, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Mycosis Fungoides, Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified, Sezary Syndrome, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (durvalumab)
Arm Type
Experimental
Arm Description
Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (durvalumab, lenalidomide)
Arm Type
Experimental
Arm Description
Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, CC5013, CDC 501, Revlimid
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
CTCL specific response assessed by Lugano Classification
Description
CTCL response will be used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool will be used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification will be used.
Time Frame
Up to 12 months
Title
Dose limiting toxicity assessed by CTCAE version 4.03
Description
Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Time Frame
Up to 84 days
Title
Duration of complete response
Time Frame
Date when criteria for CR first met until time of loss of CR (relapse/recurrence) or death (as a result of MF/SS or acute toxicity of treatment), assessed up to 12 months
Title
Event-free survival
Description
Will be estimated using the product-limit method of Kaplan and Meier.
Time Frame
From date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, assessed up to 12 months
Title
Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03
Description
Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Time Frame
Up to 90 days post-treatment
Title
ORR defined as proportion of patients with complete response (CR) and partial response (PR)
Time Frame
Up to 12 months
Title
Overall survival
Description
Will be estimated using the product-limit method of Kaplan and Meier.
Time Frame
From date of first dose of study drug to date of death from any cause, assessed up to 12 months
Title
Progression free survival
Time Frame
Date of initiation of treatment to first date meets criteria for progressive disease or death as a result of any cause, assessed up to 12 months
Title
Response duration
Description
95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapies.
Time Frame
From the date of first documented response to the date of first documented disease relapse, progression or death whichever occurs first, assessed up to 12 months
Title
Time to response
Time Frame
Date of initiation of treatment to date when criteria for response (PR or CR) first met, assessed up to 12 months
Secondary Outcome Measure Information:
Title
Pruritus assessment
Description
Changes in pruritus VAS score will be assessed using descriptive statistics.
Time Frame
Baseline up to 12 months
Other Pre-specified Outcome Measures:
Title
Changes in biomarkers
Time Frame
Baseline up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Registered into Revlimid REMS program Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 Relapsed/refractory disease Failed >= 2 prior systemic therapies *NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF; Phase 2: >= stage IB Stage of disease according to TNMB classification Pathology report must be diagnostic or be consistent with MF/SS criteria SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count Baseline skin biopsy taken within 6 months available for central review submission PERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY Histologically confirmed PTCL as defined by World Health Organization (WHO) 2008 criteria Measurable and/or evaluable disease per Lugano Classification Absolute neutrophil count (ANC) >= 1000/mm^3 * Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement Platelets >= 100,000/mm^3 * Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement Total serum bilirubin =< 2.2 mg/dL Aspartate aminotransferase (AST) =< 2 x upper limit of normal (ULN) Alanine aminotransferase (ALT) =< 2 x ULN Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =< 1.5 x ULN * If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants Female of childbearing potential: negative urine or serum pregnancy test * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Female of child bearing potential: willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication * Childbearing potential defined as not being surgically sterilized or have not been free from menses for > 1 year Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy Exclusion Criteria: Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs) Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy Any skin-directed therapy within 14 days prior to initiating protocol therapy Any radiation therapy within 21 days prior to initiating protocol therapy Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion: Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days Systemic corticosteroids at physiologic doses of < 10 mg/day of prednisone or equivalent Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy History of pneumonitis (non-infectious) that required steroids or current pneumonitis Disease free of prior malignancies for >= 5 years with the exception of: Currently treated squamous cell and basal cell carcinoma of the skin Carcinoma in situ of the cervix, or Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or Any other malignancy that has/have been curatively treated with surgery and/or localized radiation Allergic reaction/ hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab Female only: pregnant or lactating Prior stem cell transplantation Acute infection requiring systemic treatment Known history of human immunodeficiency virus (HIV) infection Active hepatitis B or C infection Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy Current peripheral neuropathy >= grade 2 Renal failure requiring hemodialysis or peritoneal dialysis Unstable cardiac disease as defined by one of the following: Cardiac events such as myocardial infarction (MI) within the past 6 months NYHA (New York Heart Association) heart failure class III-IV Uncontrolled atrial fibrillation or hypertension Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: Vitiligo or alopecia; Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or Psoriasis not requiring systemic treatment History of primary immunodeficiency Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Querfeld, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Querfeld, MD
Phone
626-256-4673
Email
cquerfeld@coh.org
First Name & Middle Initial & Last Name & Degree
Christiane Querfeld, MD
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven M. Horwitz, MD
Phone
212-639-3045
Email
horwitzs@mskcc.org
First Name & Middle Initial & Last Name & Degree
Steven M. Horwitz, MD
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierluigi Porcu, MD
Phone
215-955-8874
Email
Pierluigi.Porcu@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Pierluigi Porcu, MD
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle A. Fanale, MD
Phone
713-792-2860
Email
mfanale@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Michelle A. Fanale, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32632956
Citation
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Results Reference
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Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

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