Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Givinostat hydrochloride

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Eligible patients had to be treated with weekly single doses of ITF2357 according to the above mentioned treatment plan.

Treatment was to be administered on an inpatient basis from week 1 to week 13 and on an outpatient basis from week 14 to anticipated end of treatment (week 18). The patients had to be hospitalized on day 1 every week. The Investigator had to administer ITF 2357 in one single dose (two or three 200 mg capsules at one time) under his/her direct control.

ITF2357

Giorgio La Nasa, MD

Primary objective:

To assess the safety of ITF 2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma.

Secondary objectives:

1. To evaluate the anti-tumour activity of ITF 2357 administered once weekly at high pulse dose in patients with advanced multiple myeloma, measured as decrease of M protein.
2. To assess the therapeutic response to ITF3257 according to EBMT criteria.
3. To determine pharmacokinetic profile of ITF 2357 administered following high pulse dose schedule.

This is open label, phase IIa High Pulse Dose Clinical Trial testing ITF2357 (orally administered) in adult patients with relapsing/refractory multiple myeloma after at least 2 previous lines of treatment.

Patients are planned to receive ITF2357 in accordance with following scheme:

Weeks 1-6

Patient #01 is planned to receive ITF 2357 at 400 mg in one single dose on day 1, 8, 15, 22, 29 and 36. Safety assessments are planned to be performed twice a week. If no issue (grade \>3 neutropenia or any other grade ≥3 toxicity) emerges at day 15, two further patients (#02 and #03) will be enrolled and receive the same dose. If patients #02 and #03 show a favourable safety profile at day 15, and in the meantime no safety concerns arise from patient #01, the further patients will be enrolled and treated according to the below reported scheme:

* 8 more patients (#04-11) will receive 400 mg once weekly; safety assessments will be performed weekly.
* 1 patient (#12) will receive 600 mg once weekly; safety assessments will be performed twice a week.

If no safety concern emerges from patient 12 at day 15, two further patients (#13 and #14) will be enrolled and treated with 600 mg once weekly. If patients #13 and #14 don't show relevant safety concerns (grade \>3 neutropenia or any other grade ≥3 toxicity) at day 15, and in the meanwhile patient #12 maintains a favourable safety profile, eight further patients (#15-22) will be recruited and receive the same treatment regimen.

If grade \>3 neutropenia or any other grade ≥3 toxicity appear at any time during week 1-6, the treatment will be permanently discontinued.

In this phase, treatment will be administered on an inpatient basis.

Weeks 7-12

For patients still on therapy at day 43 visit, M protein will be quantified and the treatment continued or possibly modified as follows on the basis of this parameter:

Decrease \>or= of 25%:

patients in 400/week group continue 400mg for 6 further weeks patients in 600/week group continue 600mg for 6 further weeks

Stable +or- of 25%:

patients in 400/week group increase to 600mg and continue for 6 further weeks patients in 600/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 600mg for 6 further weeks

Increase \> of 25%:

patients in 400/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 400mg for 6 further weeks patients in 600/week group failure:out of the study patients in 600/week group

Safety assessments will be performed at weekly intervals. In case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.

In this phase treatment will be administered on an inpatient basis.

Weeks 13-18

For patients still on therapy at day 85 (week 13, day 1), the response rate will be quantified according to EBMT criteria. In case of response (complete, partial or minimal) or stable disease (no change) the treatment will be prolonged until week 18, whereas in case of disease progression the patient will leave the study. A new complete efficacy evaluation will be performed at day 127 (end of treatment).

During this phase safety will be assessed at weekly intervals and in case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.

This phase of the study will be conducted on an outpatient basis.

No dosage modification or temporary discontinuation is admitted.

Only one patient has been enrolled. The drug was ineffective in determining an improvement of the patient's disease status according to the EBMT response criteria.The study was prematurely discontinued for lack of recruitment.No firm conclusion on the safety and efficacy of ITF2357 administered at high (400 or 600 mg) single weekly doses can be drawn from the data collected from the only one patient recruited.

Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Phase II High Pulse Dose Clinical Trial of Orally Administered ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Number of patients with TEAE, included serious AE, was assessed while receiving once weekly ITF2357 at high pulse dose.

Anti-tumour activity of ITF 2357 was measured as decrease of M protein. While the clinical response rate was represented by a Partial or complete response according to the EBMT criteria.

Italfarmaco

Lymphoma

Hodgkin Disease

Lymphatic Diseases

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

Mechlorethamine

Patients received the following therapy cycle

* ITF2357, 50 mg every 6 hours, per os, days 1 - 3;
* Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there was no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.

The mean number of complete treatment cycles received by patients was 5.25, with a minimum of 1 cycle and a maximum of 12 cycles.

ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.

Alessandro Massimo Gianni, MD

This study has the following objectives:

Primary Objective

* To evaluate the anti-lymphoma efficacy of daily oral doses of ITF2357 followed by intravenous Mechlorethamine administered to patients with refractory/relapsed Hodgkin's lymphoma.

Secondary Objective

- To evaluate the safety and tolerability of multiple courses of ITF2357 followed by Mechlorethamine in a population of chemotherapy pretreated patients.

This is a single-center, open label, phase II study aimed at testing the activity of multiple cycles of ITF2357 followed by Mechlorethamine administered to patients with relapsed/refractory Hodgkin's lymphoma.

Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by Mechlorethamine according to the following schema:

* ITF2357, 50 mg every 6 hours, per os, days 1 - 3
* Mechlorethamine, 6 mg/sqm, intravenously , day 4 Study therapy will be administered every 21 days as long as there is no evidence of progressive disease or unacceptable adverse events or patient's request to discontinue treatment occurs, but in any case for a maximum of 12 cycles.

Decision regarding the continuation of ITF2357/Mechlorethamine therapy will be made on (i)the basis of tumor reassessment following cycles 2, 6, 9, and 12 and (ii) the occurrence of toxicity. Tumor response will be evaluated according to the International Working Group response criteria HL.

Treatment will be administrated on an outpatient basis and patients will be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalisation, the treatment will be continued or interrupted according to the Investigators' decision.

The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the study is about 24 months.

Histone deacetylases (HDACs) are enzymes involved in the remodeling of chromatin, and have a key role in the epigenetic regulation of gene expression. In addition, the activity of non-histone proteins can be regulated through HDAC-mediated hypoacetylation. In recent years, inhibition of HDACs has emerged as a potential strategy to reverse aberrant epigenetic changes associated with cancer, and several classes of HDAC inhibitors have been found to have potent and specific anticancer activities in preclinical studies.

Hodgkin's lymphoma (HL) is a relatively uncommon lymphoma histotype, with an incidence in Italy of approximately 1700 new cases per year (approximately 12% of all lymphomas). Combination chemotherapy with or without radiotherapy cures approximately 70 percent of advanced-stage HL. Fifty percent of the failing patients can be salvaged by second line chemotherapy (mainly high-dose regimens), while the remaining patients eventually die by disease progression. The development of an effective salvage regimen for this refractory/resistant population represents a true unmet medical need.

The use in the latter patient subset of HDAC inhibitors, like ITF2357, is supported by several considerations. Namely: (1) a related hydroxamate, SAHA, has shown activity in this clinical condition; (2) the drug markedly inhibits the production of several cytokines, and cytokine production in HL granuloma has a defined role in the pathogenesis of HL; (3) an effective treatment for refractory/relapsed HL is presently lacking; (4) ITF2357, up to 200 mg daily per os, has shown a favorable toxicity profile. All the above mentioned arguments represent a strong rationale prompting the use of ITF2357 in this patient population.

Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma

Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma Patients

OR rate among patients treated is defined according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group.

In medicine, a response rate is the percentage of patients whose cancer shrinks or disappears after treatment.

The FDA definition of ORR is the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period.

The tumor objective response rate (ORR) is an important parameter to demonstrate the efficacy of a treatment in oncology.

The ORR is valuable for clinical decision making in routine practice and a significant end-point for reporting the results of clinical trials.

Complete responder (CR) and partial responder (PR) among patients treated are defined according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group.

CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

PR is defined as regression of measurable disease and no new sites. The frequencies of patients achieving objective response (i.e. subjects whose best overall response was CR or PR) and the frequencies of patients who did not achieve an objective response (i.e.subjects whose best overall response was equal to stable disease - SD, progressive disease - PD - or not evaluable) in ITT and PP populations are reported.

NED= no evidence of disease

PFS is defined as the time from the 1st day of the 1st cycle of treatment until objective tumor progression or death. It included deaths, thus could be correlated to overall survival. If a patient did not have disease progression, PFS was censored at the date of last available tumor assessment (including those at end of study or follow-up visit).

TTR is defined as the time from the 1st day of the 1st cycle until the date of achieving a response (CR or PR).

In case of no objective response, TTR was censored at the date of last available tumor assessment (including those at end of study or follow-up visit).

Duration of objective response (CR or PR) was applied only to patients whose best overall response was CR or PR.

Patients will receive the following therapy cycle

* ITF2357, 50 mg every 6 hours, per os, days 1 - 3;
* Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy will be administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.

ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Italy

Region of Enrollment

Maurizio Caserini, MD

Objective Response achieved

Objective Response not achieved

Patients received the following therapy cycle

* ITF2357, 50 mg every 6 hours, per os, days 1 - 3;
* Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there is no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycles.

ITF2357: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.

ITT Population

PP Population

Intent-to-treat population: all patients valid for Safety population. Per Protocol population: all recruited patients who: 1) were not severe protocol violators; 2) had at least one on-study tumor assessment beside baseline; 3) experienced disease progression or, if not, received at least 2 cycles of the study treatment consecutively.

Objective Response Rate (ORR)

CR/NED

Not evaluable

Proportion of Responders (Complete -CR- or Partial PR-)

Progression-Free Survival (PFS)

Time To Response (TTR)

Response Duration (RD):

Overall Study

Polycythemia Vera

Polycythemia

Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Antisickling Agents

Hydroxyurea

50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy

GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea

50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy

GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea

Alessandro Rambaldi, MD

The primary objective of the study was to evaluate the efficacy of Givinostat in combination with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to the maximum tolerated dose of hydroxyurea monotherapy.

The secondary objectives of this study were:

* To evaluate the safety and tolerability of Givinostat in combination with hydroxyurea in patients with JAK2V617Fpositive PV non-responders to the maximum tolerated dose of hydroxyurea monotherapy;
* To explore the impact in terms of efficacy and tolerability of Givinostat 50 mg dose escalation in patients not achieving at least a partial response at the time when the primary endpoint was assessed (week 12);
* To evaluate the molecular response (JAK2 mutated allele burden) by quantitative Real Time-Polymerase Chain Reaction (RT-PCR);
* To evaluate the reduction of the fraction of JAK2V617F positive clonogenic progenitors.

This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Recruited patients will be randomly assigned to one of the following treatment groups:

* group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study;
* group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study.

The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.

In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.

After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:

* Partial or Complete Response at week 12:
* group A: continue 50 mg o.d.;
* group B: continue 50 mg b.i.d.;
* No Response at week 12:
* group A: increase to 50 mg b.i.d.;
* group B: increase to 50 mg t.i.d.. At any time during study course, if toxicity is observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.

The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera

Phase II Study of the Histone-deacetylase Inhibitor GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Patients With JAK2V617F Positive Polycythemia Vera Non-responder to Hydroxyurea Monotherapy.

The percentage of patients with overall (complete or partial) response at week 12 were assessed. · Complete response: 1. HCT (Hematocrit) \< 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC (white blood cell) ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); · Partial response: 1. HCT \< 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; · No response: any response that did not satisfy the criteria set for partial response.

Haematological response after a 50 mg increase of the initial Givinostat dose in non-responder patients at the time when the primary endpoint was assessed (week 12).

* Complete response:

  1. HCT\< 45% without phlebotomy, and
  2. platelets ≤ 400 x109/L, and
  3. WBC ≤ 10 x 109/L, and
  4. no splenomegaly, and
  5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache);
* Partial response:

  1. HCT \< 45% without phlebotomy, or
  2. fulfilment of at least 3 of the other above mentioned criteria;
* No response:

any response that did not satisfy the criteria set for partial response.

To determine JAK2V617F mutational status, a quantitative RT-PCR (Real Time-Polymerase Chain Reaction) is executed on peripheral blood granulocyte and haematopoietic colonies (with and without hepatocyte growth factors - HGFs).

JAK2V617F genotyping and quantification were performed on gradient-separated mononuclear cells during the pre-treatment evaluations (baseline), halfway through the study (12th weeks) and at the end of the study period (24th weeks).

Baseline: n=22 (50 mg od); 22 (50 mg bid) Week 12: n=20 (50 mg od); 19 (50 mg bid) Week 24: n=18 (50 mg od); 18 (50 mg bid)

50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy

GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy

GIVINOSTAT + MTD Hydroxyurea_1

50 mg b.i.d. of GIVINOSTAT + MTD of HU monotherapy

GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy

GIVINOSTAT + MTD Hydroxyurea_2

Total

Safety/Intention-to-treat (ITT) population, which included all randomized subjects who received at least one dose of study medication.

Carlo Bianchini, MD

Responder

Non responder

Safety/ITT population: included all randomized subjects who received at least one dose of study medication.

Percentage of Patients With Overall Haematological Response at Week 12.

Safety/Intention to treat (ITT) population included all randomized subjects who received at least one dose of study medication.

Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12.

Week 12

Week 24

Drop-out

Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR

Baseline - heterozygous

Baseline - homozygous

Baseline - not done

week 12 - heterozygous

week 12 - homozygous

week 12 - not done

week 24 - heterozygous

week 24 - homozygous

week 24 - not done

Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints

50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of hydroxyurea (HU) monotherapy

GIVINOSTAT (ITF2357) 50 mg o.d. + maximum tolerated dose (MTD) of Hydroxyurea (HU): 50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_1

50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

GIVINOSTAT (ITF2357) 50 mg b.i.d. + maximum tolerated dose (MTD) of Hydroxyurea (HU): 50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

GIVINOSTAT +Maximum Tolerated Dose (MTD) of Hydroxyurea (HU)_2

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

ITF2357 was supplied as hard gelatine capsules for oral administration at the strength of 100 or 50 mg. Patients had to receive ITF2357 100 mg x 2/die at 12-hour intervals, in fed conditions, for three consecutive months.

Massimo Martelli, MD

Primary objective:

- To determine overall response-rate, complete response (CR) or partial response (PR)

Secondary objectives:

* To assess the safety and tolerability of ITF2357;
* to assess total rate of responders (complete + partial responders);
* to determine the 6 months progression free survival;
* to determine the effects of the drug on haematological parameters.

This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a population of CLL patients relapsed after or refractory to conventional chemotherapy or relapsed after autologous bone marrow transplantation.

Patient received ITF 2357 orally at the dose of 100 mg x 2/die for three months with subsequent dose modifications if requested by the patient's conditions.

The study was prematurely discontinued due to recruitment problems. Since February 2008, date of first patient's first visit, until April 2009, date of early study discontinuation, only 3 patients were enrolled. The Sites involved in the study were 6 but only two actively recruited patients.

CLL is the most frequent type of leukemia in the western world and affects mainly elderly individuals, although about one third of patients are less than 60 years of age at diagnosis.

CLL is a heterogeneous disease characterised by a surprisingly diverse clinical course with patients that may have an overall survival time ranging from months to decades.

CLL accounts for approximately 7000 new cases and 4500 deaths per year in the US.

Chemotherapeutic treatment of CLL is largely ineffective and despite new emerging therapies, CLL still remains an incurable disease.

ITF 2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research Laboratories, provided with an established and powerful HDAC-inhibitory activity (see below for further details). It is being developed for a range of possible clinical applications both in oncohaematological conditions and in chronic inflammatory diseases. The former application is consistent with the well known antitumor pharmacological properties of HDAC-inhibitors as a family (i.e. cell-cycle arrest, pro-apoptotic and cell-differentiating effects); the latter application (chronic inflammation) is based of the demonstrated anticytokine effect of ITF 2357.

Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia

Open Label, Uncontrolled, Pilot, Phase II Study of ITF2357 Administered Orally to Subjects With Chronic Lymphocytic Leukemia (CLL) Refractory/Relapsed After Conventional Chemotherapy or Relapsed After Autologous Bone Marrow Transplantation

ITF2357 was given at 100 mg x 2/die for up to three months. A positive response was defined to be a patient experiencing a complete or partial remission.

Complete remission (CR) Absence of lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms.

Normal blood count: neutrophils ≥1.5x109/L, platelets \>100x109/L, lymphocytes ≤4.0x109/L, Hb \>11.0 g/dL (not supported by transfusion), BM biopsy: normal cellularity, lymphocytosis \<30%.

Partial remission (PR)

≥50% reduction in blood lymphocytes and ≥50% reduction in lymphadenophaty and/or 50% reduction in hepatomegaly and/or splenomegaly. Neutrophils ≥1.5x109/L or 50% improvement over baseline, platelets \>100x109/L or 50% improvement over baseline, Hb \>11.0 g/dL or 50% improvement over baseline (not supported by transfusion) It was considered PR

* CR with nodular infiltrates at bone marrow biopsy (RPn)
* CR with persistent anemia and thrombocytopenia therapy-related

ITF2357 was given at 100 mg x 2/die for up to three months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma	NCT00792506	Multiple Myelom...	ITF2357	18 Years -	Italfarmaco
Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma	NCT00792467	Hodgkin's Lymph...	ITF2357	18 Years -	Italfarmaco
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera	NCT00928707	Polycythemia Ve...	GIVINOSTAT (ITF... GIVINOSTAT (ITF...	18 Years - 80 Years	Italfarmaco
Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia	NCT00792831	Chronic Lymphoc...	ITF2357	18 Years - 75 Years	Italfarmaco
Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma	NCT00792467	Hodgkin's Lymph...	ITF2357	18 Years -	Italfarmaco

Spots Global Cancer Trial Database for itf2357

Every month we try and update this database with for itf2357 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for itf2357

Every month we try and update this database with for itf2357 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for itf2357 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.