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NCT Number: NCT01022996

Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.

This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California at Los Angeles UCLS School of Medicine, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a history of classical Hodgkin's lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment
  • Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by PET and CT Scan (or MRI)
  • Patients with adequate bone marrow, liver and renal function (confirmed by laboratory values)
  • Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN

Exclusion criteria

  • Previous treatment with mTOR inhibitors
  • Prior allogeneic stem cell transplant
  • Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other investigational drugs within 4 weeks of starting study treatment
  • Another malignancy within 3 years of study entry (except adequately treated non-melanoma skin cancer and carcinoma in situ of the cervix)
  • Severe and/or uncontrolled medical conditions that could affect participation in this study
  • Female patients who are pregnant or breastfeeding; patients who are not willing to use adequate birth control during the study and for 8 weeks after the last study treatment Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Everolimus (RAD001)

Drug

Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.

Other names: RAD001

Primary outcomes

  1. Overall Response Rate (ORR) Based on the Assessments by Investigator

    Time frame: at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal & extranodal lesions: Radiological regression to normal size of all lymph nodes & nodal masses & complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal & extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal & extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented & one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.

Secondary outcomes

  1. Time to Overall Response (TTR) Per Kaplan-Meier Estimate

    Time frame: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.

  2. Duration of Overall Response (DoR)

    Time frame: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.

  3. Disease Control Rate (DCR)

    Time frame: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).

  4. Duration of Disease Control

    Time frame: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.

  5. Progression Free Survival (PFS) by Kaplan-Meier Estimate

    Time frame: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason

    Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 1, 2009
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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