A Phase II Study of Oral Panobinostat in Adult Patients with Relapsed/Refractory Classical Hodgkin?s Lymphoma after Failure of High-dose Chemotherapy with Autologous Stem Cell Transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-Containing Treatment Regimen - ND
- Conditions
- Relapsed/Refractory Classical Hodgkin?s LymphomaMedDRA version: 9.1Level: LLTClassification code 10020328Term: Hodgkin's lymphoma
- Registration Number
- EUCTR2008-003016-35-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
1. Patient age is ≥ 18 years 2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted) 4. Patient has progressive disease after receiving high dose chemotherapy with AHSCT 5. Patient has progressive disease on or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, after first relapse. Note: If last therapy was more than ≥ 18 months ago, then a biopsy should be performed to confirm diagnosis. Note: Patients will be allowed on study who have also received an allogeneic hematopoietic stem cell transplant, however this therapy alone is not sufficient for inclusion into this study. 6. Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan can not be performed). See Post-text supplement 1. Note: Patients with bone marrow involvement are eligible, but this criteria alone should not be used for disease measurement. 7. Patient has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail): Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L [SI units 1.5 x 109/L] Platelet count ≥ 75 x 109/L Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patient has a history of prior treatment with a DAC inhibitor including panobinostat. 2.Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment. 3.Patient has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment. 4.Patient has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1. 5.Patient has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples). 6.Patient has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1. 7.Patient is using any anti-cancer therapy concomitantly 8.Patient has been treated with allogeneic hematopoietic stem cell transplant who has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD). 9.Patient has a history of another primary malignancy ≤ 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix 10.Patient has a history of CNS involvement with lymphoma. 11. Patient has impaired cardiac function (see protocol for details). 12. Patient has any other clinically significant heart disease (e.g., uncontrolled hypertension). 13. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection). 14. Patient has unresolved diarrhea ≥ grade 2 15. Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol. 16. Patient has a known HIV seropositivity. 17. Patient has active bleeding diathesis or is currently being treated with therapeutic doses of sodium warfarin (Coumadin)or other vitamin K active agents Note: mini-dose of Coumadin (e.g., 1 mg/day) or anti-coagulants given to maintain intravenous line patency, as well as unfractionated or low molecular weight heparin therapy is permitted. 18. Patient is using medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug 19. Patient is a woman who is pregnant or breast feeding, or a women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study through 3 months after the end of treatment. One of these methods of contraception must be a barrier method. 20. Male patient whose sexual partner(s) are WOCBP who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method